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Charles Murphy, Cloud and Customer Success Leader, IQVIA Quality Compliance Solutions

With the advent and continuing adoption of new technologies such as cloud computing, big data, and artificial intelligence, deeper and lasting relationships at both the consumer and enterprise levels have become necessary to achieve successful business outcomes. Customer Success is the term used to describe this paradigm shift in the business world, reminiscent of the transformation last seen when IT became a value driver, in addition to a core function, within organizations.

Customer Success focuses on helping customers achieve their business objectives by optimizing the customer experience and customer satisfaction through innovative products, excellent service delivery, outstanding support, and reliable operations service levels.

Customer Success Drives Quality

Among QMS technology providers, the most successful Customer Success teams are proficient at meeting customers where they are and assisting them to move forward on their Quality Maturity journey. This is particularly evident among Life Sciences organizations where Quality is critical to their mission of provide life-altering and life-saving products and services.

Successful technology provider teams consistently monitor their customers’ progress, as well as the use and effectiveness of their technology products and services by their customers, particularly in several key focus areas:

  • Product Adoption
  • Onboarding
  • Reliable Support and Operations Service Levels
  • Customer Engagement

World-class technology provider teams are comprised of an integrated collective of specialized support and services teams, all striving together to ensure the customer experience within each of these focus areas is excellent, seamless, and consistently leading to increased Customer Satisfaction.

Product Adoption

To fully realize the value of the investment made in any product or technology platform, it is important that the product features, functions, and processes be adopted. A successful Customer Success team will effectively guide its customers through these steps. Critical to providing guidance is knowing a customer’s industry and the global quality compliance requirements that govern it.

Key extensions to the Customer Success team in driving the customer’s success during the product adoption phase are the Product and Development teams that continuously work to evolve the product’s solution architecture and to innovate new solutions. Another extension during this phase is the solution provider’s Training teams that deliver instruction to new or existing users.

Onboarding

After the initial or continuing investment in a product or technology platform, the next factor critical to customer success is the time to realize value. The primary objectives during the onboarding process for a new technology solution are to deploy the solution in a short timeframe, with the customer-specific business requirements incorporated to a trained user population.

The provider partner contributing to customer success at this stage is the Implementation Services team. Before engaging with the customer in deploying the solution, this group should quickly ramp up to understand the customer’s requirements, and then accurately configure the technology solution to the customer’s specific operation.

During onboarding, Training Services join in the Customer Success mission to accelerate user proficiency with the solutions being implemented. A successful training program will elevate the customer’s success by making its solution users experts with the technology and arm them with knowledge to support their extended organization. With guidance from truly skilled trainers, the customer will gain a thorough understanding of the solution’s functionality and learn to maximize the benefits and total value of the solution.

In the Life Sciences, quality is essential to product efficacy, and compliance with industry regulations is mandatory. With these considerations top-of-mind, a truly world-class Customer Success operation will also will be buoyed by elite Quality and Compliance consultants who will guide related programs and processes improvements that enable the Life Science customer’s quality and compliance. These programs and processes include areas such as organizational change management, process harmonization, risk management, and remediation.

Outstanding Support and Reliable Operations Service Levels

After the trust conferred by a customer, there should always be confidence in having a reliable partner that is reachable if an issue or question surfaces. In any technology organization, essential to the supporting cast of professional teams that drive their customer’s success is an expert Technical Support team that will provide dedicated solution support from first contact through resolution.

Day-in and day-out, this team’s mantra is “Customers First.” Their continuous objective is to resolve customer inquiries as quickly as possible to reduce the customer’s time spent out of production. The goal of a truly world-class Technical Support team is to achieve 100% customer satisfaction through Total Contact Ownership, an industry best practice which guarantees the support team take full responsibility for every call every time customers request technical support services.

Customer Success is a universal concept that, when superiorly practiced, offers equal commitment to organizations that choose to implement their technology solutions in the Cloud. Today’s leading global technology providers deliver their Cloud solutions using enterprise-class infrastructure and services. For Life Sciences organization, data integrity and privacy are paramount. The world-class Cloud solution team will ensure the integrity of its customer’s data within a guaranteed secure environment. Further, successful organizations that are growing on a world stage call for cloud solutions and services that scale easily alongside them.

Customer Engagement

The distinguishing characteristic of Customer Success is listening to the Voice of the Customer at each step along the journey, and communicating internally so that actions may be taken to maintain alignment and help the customer succeed at meeting their objectives. The most accomplished Customer

Success team members are unrelenting Customer Advocates, with extensive knowledge and hands-on experience in their customers’ industry and their very own provider organization’s solutions. In a technology solution enterprise, they strive to get the most out of their customer engagement efforts by harnessing the combined power of technology and human interaction.

IQVIA Quality Compliance – World-Class Solutions Driving World-Class Customer Success

At IQVIA Quality Compliance, the focus of all employees is to ensure the customer experience is excellent, seamless, and consistent leading to increased Customer Satisfaction. Our Customer Success Team guides and coordinates these efforts, but every member of our entire extended enterprise team is focused on the success of our customers. IQVIA provides world-class solutions and is recognized for its commitment to driving worldwide Customer Success within the Life Sciences.

IQVIA Quality Compliance Fact Sheet

Learn how IQVIA can help you advance your quality maturity by supporting your people, processes and technology.

The post Achieving Customer Success with World-Class Customer Service appeared first on Pilgrim Quality Solutions Blog | Quality Management Blog.

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Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Product Quality is a given in Life Sciences organizations; after all, the purpose of producing a medical device or pharmaceutical is to improve the life of the patient using the product. The backbone to producing quality goods is a Quality Management System (QMS) that, by definition, supports the processes focused on consistently meeting customer requirements and enhancing customer satisfaction.

In a global industry environment that is constantly evolving, it is apparent that a new approach is required if organizations are to achieve the goal implicit in that definition. The Quality Management System will need to simultaneously evolve beyond the role of company historian and expand its primary focus of achieving compliance. Quality data needs to be turned into information that is informed, actionable, proactive, and predictive. In other words, information that truly fosters a culture of quality.

Looking Back

Traditionally, within the Life Sciences, an organization’s level of quality has been gauged by its compliance with regulatory requirements. Recently, we have witnessed unprecedented level of change in regulatory requirements as well as an ever-increasing level of regulatory oversight. This pressure to demonstrate compliance and support regulatory reporting puts the focus on history, and the reporting of that history. We all know the rallying cry: “We’re being inspected by [insert favorite regulatory body here], rally the troops!” And everyone works to ensure that all the documentation needed is available. This is, however, a very rear-view mirror perspective and does little to enhance the customer experience or foster a culture of continuous improvement.

Looking for Answers

As product recalls, product bans, drug shortages, plant shutdowns, and enforcement actions continue to occur, the industry and regulators alike are looking for answers. Is the answer to the challenge of improving quality found in the data and documents? After all, we have a lot of data that we so carefully record within the quality system. However, the data is not the answer. Two themes that have gained mindshare in terms of improving quality in the Life Sciences industry are Quality Maturity Models and Metrics.

Quality Maturity Models
Quality Maturity Models focus on assessing the level of quality maturity within an organization and the QMS. Maturity Models aren’t new — CMMI and Crosby’s Quality Management Maturity Grid are just two that are well known. What is new is the renewed interest by industry analysts, regulators, and corporations in applying them to Quality Management Systems. All of them measure maturity by level, determined by how a company takes action: reactive, sporadic, proactive, measured and controlled, and future-oriented (improvement oriented, predictive) in a variety of categories which include, but are not limited to, Performance Management, Technology, Business Processes, Culture, and Strategy & Leadership. Applying Quality Maturity Models to QMS will provide organizations with a roadmap for the evolution of their QMS.

Quality Metrics
All Maturity Models reference metrics to varying degrees. The Quality Metrics that we will focus on are those that are receiving interest from an atypical source, the FDA. And it’s not just one division of the FDA, but both the Center for Devices & Radiological Health (CDRH) and the Center for Drug Evaluation & Research (CDER).

Looking to Transition

Medical Devices
For Medical Devices, CDRH kicked off the Case for Quality in 2011 to determine how to shift focus from compliance to quality. This was driven by the lack of demonstrable improvement in patient safety over many years. The Case for Quality was a key part of CDRH’s 2016-2017 strategic priority to promote a culture of quality and organizational excellence. They worked with a variety of stakeholders, including industry, healthcare, patients, academia, and investors, to determine how to promote the use of practices that would result in informed decision making and action, as well as enabling the ability to predict product quality risk. The result was the establishment of a Quality Metrics initiative.

The initiative focused on three measures, one from each major phase of the product lifecycle – pre-production, production, and post-production. Each phase elicits a metric that focuses on the Right-First-Time mentality:

  • Pre-production: the metric will measure total number of changes (product and process) for each project to move towards zero post-design transfer changes.
  • Production: the metric will be the Right-First-Time production result that many organizations already measure. This metric not only assesses production efficiency, it allows for the identification of opportunities for improvement.
  • Post-production: a vast array of metrics are being assessed in the area of Complaints, Service Records, Medical Device Reporting, and Recalls.

Pharmaceuticals
CDER embarked on a similar path for the Pharmaceutical industry. Their focus also has zeroed in on quality of the product, and effectiveness of manufacturing, including site-level quality. The metrics that CDER has focused on are:

  • Lot Acceptance Rate
  • Product Quality Complaint Rate
  • Invalidated Out-of-Specification (OOS) Rate
  • Annual Product Review
  • Additional metrics being assessed include CAPA Effectiveness and Process Capability

The goal in both branches of the FDA is to improve patient health and safety. These metrics help to eliminate subjective opinion, and provide visibility and insight for continuous improvement at the site, enterprise, and industry level.

Looking Ahead

Going forward, it won’t be enough for the Quality Management System to be the company historian, gathering data for the sake of compliance. That data needs to be turned into information. Information that is informed, actionable, proactive, and predictive. Information that truly fosters a culture of quality where customer expectations are always exceeded and customer satisfaction and safety are always achieved.

How does an organization achieve this quality nirvana? It starts with a decision to embark on the journey. The destination? Enterprise Quality Management (EQM), where data is structured and allows for proper aggregation and disaggregation, where measures and processes are harmonized. An EQM journey will guide your organization to a single source of quality truth that breaks down the silos within your organization and allows you to partner with the FDA and other regulatory bodies to improve life through quality within your organization and across the industry.

The Case for Quality System Transformation

Learn how compliance, quality system maturity, and a quality culture all feed into a successful global quality system.

The post Quality Management Systems: More than the Company Historian appeared first on Pilgrim Quality Solutions Blog | Quality Management Blog.

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David Thomas, Sr. Director of Global Services, Pilgrim Quality Solutions, an IQVIA company

Frequently, I’m on the road speaking with customers and addressing quality professionals, and frequently I’m asked, “If you had to give one piece of advice to someone looking to implement an Enterprise Quality Management System (QMS), what would it be? When implementing a quality management system, the best advice is inclusion.

It’s one simple word – inclusion – but one loaded with such wide-ranging positive impact.

Benefits of an Inclusive QMS

A global implementation team is imperative to successfully implementing a global Enterprise QMS.

  • A designated team also builds global organizational buy-in and ownership to the process.
  • It also ensures that everyone’s voice is heard and that regional or product-specific requirements are considered.
  • Additionally, acceptance of the harmonized global process is more easily achieved because global communication and collaboration are demonstrated from the start.
Drawbacks of a Siloed QMS

Conversely, siloed approach will adversely result in one of two things. When implementing an Enterprise QMS, often organizations will use one site as the model for the rest of the organization. The result often is a lack of consideration for regional and product-specific requirements. This then typically results in multiple reconfigurations, or worse yet, modification of the solution in future phases. For Life Sciences organizations, this can mean additional policy, procedural, and work instructions updates. It will also require additional project overhead, re-validation of the solution, and re-training of personnel. Do this too often and project fatigue can set in, and time-to-value is significantly elongated.

Another adverse result of a siloed approach is the risk of the appearance of “acceptance.” This leads to multiple work-arounds, back-door processes, and spreadsheets and other documents to support how it “really” works. When this occurs, there is no longer a “Single Source of Quality Truth,” and the organizational synergies, efficiencies, and flexibility, as well as the global visibility and common language of the organization, are not achieved.

This doesn’t mean a complete big bang approach has to be taken during the implementation of a global Enterprise QMS. Many organizations cannot support that level of resourcing. So how does an organization reasonably make the transition from a siloed to an inclusive approach?

Best Practices for Conversion to Inclusion

An organization might start with one end-to-end process, maybe for a particular product family, with a global team leading the charge. Consider the end-to-end process for managing a nonconformance. This won’t be inclusive, just enough to depict the reason for implementing an end-to-end process rather than a siloed process.

First, take into account the sources of nonconformance; suppliers, product, processes, etc. The first consideration in an end-to-end nonconformance process is to ensure all types are identified.

To peel this back a bit more, look, for example, at a supplier nonconformance which will illustrate why an end-to-end process is key to avoiding missed integration points. At receiving inspection, a material nonconformance is created due to out-of-specification inspection results. The nonconformance investigation reveals that the material cannot be used or even re-worked for use. As a result, the material is dispositioned, an ERP inventory status update is submitted, and an ERP return material authorization is potentially triggered.

Additionally, the nonconformance investigation indicates that this is a trend for this supplier, and therefore a Corrective and Preventive Action (CAPA) is issued. The CAPA investigation uncovers the fact that a design change was not considered in the material the supplier shipped.

In turn, this triggers a supplier audit to determine why the supplier QMS processes missed the change notice, or if something changed in the suppliers’ process capabilities. Yet another possibility may be that the CAPA investigation reveals that change notices are not getting sent to this supplier because Engineering was using an outdated SOP.

This will initiate a change request to update the SOP, and additional training is triggered for the Engineering group.

This of course is a simplified example; the point for choosing an end-to-end process is this: there are both internal QMS integration points as well as external integration points that will be missed without a complete process view. Additionally, the global team needs to participate in this process to ensure regional reporting requirements are not overlooked, thereby creating the need for “rework” later.

Through the discussion above, the necessity of a global voice (inclusion) during implementation is clear if an organization is to achieve a successful implementation of an Enterprise QMS. That global voice not only ensures a harmonized process; it also drives organizational synergies, efficiency, and flexibility that work for all sites around the world. It will improve organizational acceptance and shorten global time-to-value.

The Case for Quality System Transformation On-demand Webinar

Learn how compliance, quality system maturity, and a quality culture all feed into a successful global quality system.

The post The Keys to Implementing an Inclusive Quality Management System appeared first on Pilgrim Quality Solutions Blog | Quality Management Blog.

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Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

As product recalls, product bans, drug shortages, plant shutdowns, and enforcement actions continue to rise, industry and regulators alike are looking for answers on how to change the perspective of the Life Sciences industry from one of Compliance to one of Quality.

Is the solution to increase the amount of data we capture and report within our documents? After all, we so carefully record a great deal of data in a Quality Management System (QMS). No, data in and of itself, is not the answer. While data/metrics go a long way toward accomplishing the shift from compliance to quality, that data needs to be transformed into intelligence that is informed, actionable, proactive, and predictive.

The notion of Quality Metrics is not about getting better at gathering metrics; it’s about making business better through quality in all things. The Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER) recognized this need, and both have launched Quality Metrics initiatives in the last few years to extend their industries’ and the Food & Drug Administration’s (FDA) focus beyond compliance and toward a higher assurance of quality.

Both Centers have similar goals but analyze different metrics to demonstrate quality. Some of these metrics may already exist at some level in your organization.

CDRH – Right the First Time Mentality

In 2011, the CDRH launched “The Case for Quality” to begin the shift in focus from one of compliance and enforcement action to one of device quality. The goal of this initiative is to identify ways for the medical device industry to proactively and predictively measure the risk to its own product quality, thereby enabling the industry to focus on improving product quality proportionate with the need.

The program directive is to focus on the three major lifecycle stages for a product and analyze the key metric(s) in each phase. These three phases and the quantifiable metric(s) within each are below:

  • Pre-production: the metric will measure total number of changes (product and process) for each project to move towards 0 post-design transfer changes.
  • Production: the metric will be the Right-First-Time production result that many organizations already measure. This metric not only assesses production efficiency, it allows for the identification of opportunities for improvement.
  • Post-production: a vast array of metrics are being assessed in the area of Complaints, Service Records, MDRs, and Recalls.
CDER – Product Quality

FDA announced its Quality Metrics Initiative for the Pharmaceutical industry in 2013 to determine data the industry could submit to FDA that would accurately reflect potential risk to product quality. The metrics framework was built upon driving a mindset of continual improvement that includes feedback loops across the entire enterprise to design quality into the product proactively at the source, instead of reactively catching inadequate quality after manufacture.

To achieve this, the following QMS metrics are assessed:

  • Lot Acceptance Rate
  • Product Quality Complaint Rate
  • Invalidated Out-of-Specification (OOS) Rate
Making the Transformation at Home

So, how do our organizations also shift our focus from Compliance to Quality? We can look to these FDA initiatives to build our own enterprise-wide QMS transformation roadmaps, including how we structure our data within the quality management system and then report against it.

In this age of big data, structuring your global eQMS information is imperative. Properly structured data sets are a must. The goal of properly structured data sets? Turning data into actionable information through its transformation. When properly structured, quality data can be transformed into KPIs, metrics, and measures that can be used consistently at a business unit, division, or site level. For each process, for products and product families, for customers and suppliers around the globe, this data is essential within a global enterprise Quality Management System.

Sorting Out All that Data

Quality records often require data from other systems such as the Failure Mode and Effects Analysis (FMEA) table or the Product Master Data from PLM; the production, inventory or finance data from ERP; or shipments and vendor information from Supply Chain Management solutions. Quality metrics are no different. To ensure that there is only one master data source, an eQMS needs enterprise-level integration to allow for the use of key data from other systems.

To extend the concept of a single master data source, there must be a Single Source of Truth for quality data as well. Providing the organization with that single source of quality truth is the catalyst to transforming the business. It allows us, as quality professionals, to make a case for quality transformation. The FDA’s Quality Metrics initiatives discussed above can give us some insight into how we do this, by shining a light on quality and its transformative impact on the business.

The Case for Transformation

When making the case for QMS transformation, don’t stop at the FDA metrics, however. Speak the language of the business, not just the language of quality. Focus in on the customer and operational excellence. It will be important to speak to metrics that the organization already understands. As Quality professionals, one of our jobs is to help the organization understand how the business is impacted by a quality journey.

And ultimately, ensuring the health of the business will ensure the goal of any Life Sciences organization – to provide quality products intended to improve the lives of the patients using those products.

The Case for Quality System Transformation On-Demand Webinar

Learn how compliance, quality system maturity, and a quality culture all feed into a successful global quality system.

The post The Need for QMS Transformation & Structured QMS Data appeared first on Pilgrim Quality Solutions Blog | Quality Management Blog.

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Stanley Curtis, Head of Software Engineering for SmartSolve EQMS, IQVIA

You rely on an enterprise Quality Management System (eQMS) to manage the quality of your products. Have you stopped to think about the quality of your eQMS? Do you know the level of diligence that your solution provider puts into the quality of the software that powers your eQMS? This is a guideline of what to look for when evaluating an eQMS vendor (or any software solution provider).

The most overarching part of ensuring software is developed to the highest quality standard is a strong Software Development Lifecycle (SDLC). The SDLC defines the entire process of developing software. It is here that the first notion of quality is introduced. The SDLC defines:

  • the processes for defining requirements as well as designing, building, and testing the software;
  • the appropriate workflows to follow when everything is going smoothly;
  • the processes and procedures to follow when problems arise, and defects are found; and
  • the necessary artifacts that are developed during the SDLC and the processes to successfully release the software.
Adopting Structure to Construct a Quality Framework

Without a robust SDLC, consistency and diligence suffer, creating greater opportunity for unpredictable software. The FDA does not define which SDLC must be used when developing software in the Life Sciences, but it does stipulate that an SDLC must be defined and used for software development. Some of the more common SDLC methodologies are Agile, Waterfall, and V-Model. Most SDLC methodologies are guidelines that are tailored for the specific product and company.

Whichever SDLC model you choose, it is important to ensure that it fits your needs and is consistently followed for each software development project. Equally important, your SDLC should be reviewed periodically to ensure it is still defining a methodology that when followed, produces quality software.

“The SDLC should be considered a living methodology that can be adapted for continuous improvement.”

The SDLC typically defines the SDLC processes of requirements definition, design, building, testing, and releasing the software. Depending on the SDLC methodology chosen, these processes may be implemented at different times in the SDLC, and in varying methods, with the ultimate goal of producing high quality software.

Practicing Quality to Build Quality

Requirements definition is a joint effort, typically led by Product Management, involving customers, market forces (Sales and Marketing input), regulatory inputs, engineers, and architects. A weak requirements definition process will likely result in poor quality software that may not meet the needs of the customer. Requirements should be well documented to minimize any ambiguity between the software developer and the originator of the requirements. The SDLC should define requirement tracing between the final software and the defined requirements to confirm that the software meets the requirements.

During the design and build phase of the SDLC, multiple techniques can be used to find discrepancies and defects early in the process. The earlier in the process that these discrepancies are found, the easier and less expensive they are to resolve.

Peer reviews should take place during the design process and the coding phase of the project. Design reviews and code reviews not only help to find potential software defects, but they also are excellent ways to enforce coding standards and educate other members of the team on how that piece of code works. Developers should perform unit testing on all code they develop as the first level of code testing in the product.

Quality Assurance to Assure Effectiveness

Quality Assurance (QA) activities within the SDLC should start early and occur often, and not be relegated to an afterthought. At a minimum, QA should be involved, up front, during the planning and design phases. During the early parts of the SDLC, they should be developing test plans from the requirements, participating in design reviews, and starting to build any necessary testing frameworks. Test plans should be peer reviewed for the same reasons as a developer’s code is reviewed.

Once the test plans are approved, QA engineers can start developing the tests that will be executed as part of the SDLC. The testing should be a combination of manual and automated tests. Test automation is a powerful tool for continuously looking for regressions in existing software that may have been introduced by new code or code changes. Automated regression testing should be executed frequently during the software development process to find the defects as early as possible.

Approved Consent to Signal Readiness

The release process pulls together the other phases of the SDLC to put the software into a package that is then validated and useable by the customer. During this phase, various departments, or responsible roles, sign-off on the release indicating their agreement that the software was developed following all of the necessary processes in the SDLC and the software has met the accepted quality standards.

Having a robust and documented SDLC that is followed during the software development, is a powerful tool to help ensure a high-quality product. Additional measures can enhance the quality process such as using a defined quality framework.

A Powerful Foundation for a Mature Quality System

A mature, compliant quality system requires an automated, integrated approach. That’s where IQVIA SmartSolve® QMS’ advanced compliance technology comes in. SmartSolve® is a powerful compliance platform that makes it easy to scale your quality system as the demands on it grow. The compliance platform enables quality to become a centralized hub for continuous improvement throughout your business while maintaining regulatory compliance.

SmartSolve® is developed using the Agile SDLC as we believe this provides the greatest visibility into the quality of the product as it is being produced. Test automation is one strategic component the SmartSolve product development team engages to produce a high-quality product. Additionally, IQVIA itself is ISO 9001:2015 certified in order to further strengthen its commitment to building quality QMS software.

SmartSolve Platform for Compliance Data Sheet

SmartSolve Platform for Compliance provides a powerful foundation for building a mature quality system.

The post Putting the Quality in eQMS Software appeared first on Pilgrim Quality Solutions Blog | Quality Management Blog.

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Pilgrim Quality Solutions Blog | Quality.. by Pilgrim Quality Solutions - 1M ago

Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA company

Quality Management has traditionally been an area of manufacturing that was slow to adapt and change to technology shifts in the market. Over the past few years, enterprise Quality Management Software (QMS) systems have stepped up their game and caught up to the market by bringing functionality such as 3rd-party secure access, advanced analytics, and proactive monitoring to their portfolio stacks.

What is very exciting is looking ahead to the near future as QMS systems bring the latest concepts, theories and functionality into their solutions. This blog explores three specific areas that are changing the Quality Management Landscape.

Persona-based Experiences

Quality systems of the past, typically, were simply large databases that housed documents and records for regulatory purposes. Today, with increased globalization and competition, companies are trying to get their products to market more quickly. They are uncovering that a high-functioning quality system can be an asset as it is an efficient way to organize, sort, and report on the opportunities and problems within their product portfolio.

Long gone are the days of searching through records and fields to find specific tasks or elements. Companies want users to log into the system and be presented a series of metrics and tasks based on their persona so that they quickly pinpoint their next task and move to the next issue. Quality systems are now enabling personalized dashboards where users can choose which metrics, tasks, and searches they need displayed to make their life much easier.

Machine Learning

Machine Learning, in short, is the scientific study of algorithms and statistical models that computer systems use to effectively perform a specific task without using explicit instructions, relying on patterns and inference instead. It is basically giving the user options based on historical evidence. Machine Learning is now being incorporated into QMS systems to help investigators determine root causes of issues based on historic trends, as well as to propose corrective and preventive actions to alleviate the root cause.

Imagine an investigator logging into a Nonconformance/Deviation and performing a root cause analysis. But in this instance, the system has read historical data and presents the user with potential root causes based on historical trends. The user can determine if those are the appropriate root causes and selects the option that fits the incident. Upon selection, the system will then give the users options for corrective and preventive actions based on historical performance. What traditionally could have taken the user days/weeks to perform, can now be done in a matter of hours. Machine Learning is an area that will greatly impact the future of quality management systems.

Predictive Analytics

While Machine Learning can be applied to events that have already occurred, think of Predictive Analytics as the crystal ball that looks into the future and helps prevent events from ever occurring. Leveraging their years’ worth of historical and market data, Predictive Analytics are being used to warn or notify people of potential threats or opportunities in their market.

Imagine being told that “There is a 90% probability that in 30 days you will have a major issue against a particular product/process based on the past trends in your system.” You now have advance notice of issues arising in the business. This may help you to prevent those issues from occurring. Where traditional quality management systems have responded reactively, this technology shift is driving manufacturing organizations to deploy their quality systems more proactively.

The Future is At Our Door

The standard engagement of these technologies is not far away as most are already in practice today. What is exciting is watching the industry transform into this future state.

IQVIA offers your organization solutions with capabilities for next-generation QMS success. SmartSolve® EQMS is based on best-practice quality processes that reduce organizational risk, increase efficiency, improve agility, and reduce cycle times by keeping tasks on track. With SmartSolve, compliance is built-in, so the focus can be on quality.
 

Smart Quality Management E-book

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The post The Future of QMS appeared first on Pilgrim Quality Solutions Blog | Quality Management Blog.

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Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Despite the best efforts of industry and regulators alike, quality issues are on the rise. Product complaints are up, along with product recalls, drug shortages, product bans, plant shutdowns, and enforcement actions. This means that industry and regulators alike are looking for answers.

It happens that many of these answers lie within your existing deviation management processes and data. The key to addressing these increasingly common issues is understanding the true driver behind Good Manufacturing Practices (GMP), and then structuring your deviation and quality management processes accordingly.

Ultimately, GMP is all about the patient and achievement of customer expectations through conformance to their requirements. It’s all about improving the life of the patient using the product. That’s why regulators are increasingly digging into not just the ability to comply with regulations, but sustainability — the ability to produce high-quality product over and over again.

GMP and the Pharmaceutical Product Lifecycle

The management of deviations is not just a GMP concept, it spans the entire product lifecycle, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). Here we’re focusing on GMP because the need to properly manage deviations is compounded by the fact that the product is in the broad market.

At a minimum, GMP requires written procedures for the following:

  • Control of components, drug product containers, and closures
  • Production and process controls
  • Packaging and labeling control
  • Holding and distribution
  • Laboratory controls
  • Complaints

Additionally, while there are various GMP standards, each of them, whether ICH, the FDA, or the EU GMP standard, requires the documentation of any deviation.

Deviations Defined

A deviation is any departure from an approved instruction, procedure, specification, or standard. In a recent blog entitled A Deviation By Any Other Name, it’s noted that historically, the Pharmaceutical industry has called a “deviation” by two other names: either “unplanned deviations” or “planned deviations.” However, the regulators are asking industry to move away from that nomenclature as a best practice.

Temporary Changes (a.k.a. Planned Deviations) are pre-approved deviations from the current operational document or system, covering a specified period of time or number of batches.

Temporary Changes must be approved before execution and should be handled through approved change control procedures. All changes should be evaluated for product impact, significance, and the need for requalification or revalidation.

Generally speaking we should work hard not to abuse temporary changes. Too many temporary changes demonstrates process control, stability, and repeatability problems.

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Deviations (a.k.a Unplanned Deviations) are also known as incidents, unplanned events, or uncontrolled events. The source of deviations include, but are not limited to:

  • Human error
  • Malfunctioning or breakdown of equipment or instrumentation
  • Utility or service failure
  • Yield deviation

A deviation indicates a state of noncompliance from the designed systems or procedures at any stage of manufacturing, packaging, testing, holding, or storage of drug product.

Managing deviations and other unexpected quality events is required by GMP, but properly capturing and measuring these events builds the foundation for the quality improvements regulators will demand from your organization as they renew their focus on quality.

The New Mission: Focus on Quality

Let’s investigate just one example of a regulatory bodies’ renewed focus on quality. The Center for Drug Evaluation and Research (CDER) published in November of 2016 their most recent Guidance for Industry on the Submission of Quality Metrics Data.

There are three metrics to focus on:

  • Lot Acceptance Rate
  • Product Quality Complaint Rate
  • Invalidated Out of Specification Rate (IOOSR)

Each of these metrics focuses on determining product and process quality and sustainability. What does this mean for the Pharma industry? It means we need to think differently about quality and the systems we deploy to manage it, because quality data is becoming critical to compliance.

Need to Think Differently

In this age of big data, structuring your global quality system data is imperative, and properly structured data sets are a must. The goal of properly structured data sets is to turn data into actionable information through its transformation. Properly structured quality data may be transformed into KPIs, quality and compliance metrics, and other measures that can be used consistently at a business unit, division, or site level. For each process, for products and product families, and for customers and suppliers around the globe, this data structure is essential within a global enterprise quality management system.

A Single Source of Quality Truth

Beyond metrics and compliance, the destination of the journey to global enterprise quality management is arriving at a single source of quality truth for the organization. This includes information from the many sources of deviation data that a global, integrated quality system provides.

It is no longer sufficient for the quality management system to be the company historian, recording the events of the organization. Those events, or more accurately the data from those events, must be turned into information. Information that can be used to identify and diagnose quality problems, and predict and prevent quality events as well.

The ability to identify and respond to opportunities for improvement needs to be added to the charter for enterprise quality management, along with the proper use of the information that deviation data can provide. Whether that data is coming from planned or unplanned deviations, out of specification results, complaints, or other nonconformances, it will open the door for improved quality through controlled change management.

Streamlined Deviation Management with IQVIA

IQVIA provides enterprise quality management solutions to help Life Sciences organizations address Quality Events. SmartSolve® Deviation Management provides a closed-loop workflow to capture, verify, disposition and investigate product and process deviations. Contact us today to learn more.

The post Deviation Management: Taking GMP Compliance to the Next Level appeared first on Pilgrim Quality Solutions Blog | Quality Management Blog.

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Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Unforeseen, unanticipated, unpredicted, unplanned, unexpected. These words are typically undesirable descriptors of actions or events. Among Pharmaceutical quality and compliance professionals, they elicit downright fear because the occurrence of an unexpected event signals that something in their organization’s processes or procedures is not completely under control, and detrimental impact to patient safety is likely. For this highly regulated industry, such occurrences carry regulatory implications.

One associated regulatory standard, the FDA’s 21 CFR 211.192, states: “Any unexplained discrepancy…shall be thoroughly investigated…The investigation shall extend to other batches…that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and follow-up.”

EudraLex, The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the World Health Organization (WHO), and other agencies around the globe have standards and guidances that reflect the same.

Regulatory bodies around the globe are increasingly shifting their focus from compliance to quality, and more specifically, to the sustainability of quality within Pharmaceutical organizations. This means that your organization’s quality system needs to be ready to manage the unexpected.

But how does one manage what it doesn’t anticipate? By properly documenting, investigating, and correcting unplanned events that vary from the expected. Additionally, it should allow for preventive actions to minimize or eliminate the risk of re-occurrence.

Manage the Unexpected

“To expect the unexpected shows a thoroughly modern intellect.” ~ Oscar Wilde, Dramatist

Pharmaceutical quality professionals are trained to anticipate the unexpected, and it is important to have tools and processes in place to manage the unexpected when it occurs. For example, when a batch doesn’t come out as expected or when a lab result is out of specification, when documented procedures aren’t followed, or a process fails to complete as expected, your team needs to know what steps to take to record the problem, understand its risk, and investigate accordingly. That’s why you have tools like Failure Mode and Effects Analysis (FMEA), procedures that detail the steps to take when a problem occurs, corrective and preventive action management processes, and change control.

Common unplanned deviations include, but are not limited to:

  • Malfunctioning equipment
  • Instrument breakdown
  • Utility or service failure
  • Human error
  • Yield deviation
  • Unapproved changes to processes or product ingredients
  • Operating outside of defined limits

Managing these quality processes – which ideally integrate with and trigger one another – in manual or siloed systems becomes tricky. It’s difficult to ensure that the right steps are consistently taken to resolve a problem, and this consistency is critical to maintaining quality and compliance. Whether you’re recording a deviation, out of specification result, customer complaint, or other quality event, each must be carried out in a harmonized way to ensure ongoing improvement.

Measure the Unexpected

An enterprise Quality Management System (QMS) provides integrated, automated processes to manage, correct, and when possible, prevent the unexpected, smoothly and consistently. The ultimate goal of a QMS is to improve quality and efficacy through continuous improvement, thereby improving patient safety and satisfaction. One of the ways EQMS does this is by turning data into information. Harmonized, codified QMS data allows for the delivery of reports and analytics that adequately measure the unexpected turning that data into actionable information.

A QMS ensures:

  1. Consistent data capture for key elements such as failure mode, product, risk, and root cause.
  2. Data analysis and threshold alerts to understand ongoing results and trends, identifying systemic problems that need correction and prevention.

“Any enterprise CEO really ought to be able to ask a question that involves connecting data across the organization, be able to run a company effectively, and especially to be able to respond to unexpected events. Most organizations are missing this ability to connect all the data together.” ~ Tim Berners-Lee, Inventor

Play a Role in Setting the Industry’s Yardstick

The Center for Drug Evaluation and Research (CDER) has recently begun focusing on Pharmaceutical product quality and the effectiveness of manufacturing at the site level. The metrics under review are:

  • Lot Acceptance Rate
  • Product Quality Complaint Rate
  • Invalidated Out-of-Specification (OOS) Rate
  • Annual Product Review
  • CAPA Effectiveness
  • Process Capability

This program is still in pilot mode, which means there is still time for your organization to impact this program. If you join the pilot program now, your organization will be ready when the new measurements are required.

Beyond the compliance implication, documenting and analyzing the unexpected can serve as the platform for organizational and product improvement, and risk prevention as well.

Prevent the Unexpected

Once you’re able to consistently manage and measure the unexpected within your organization, it’s time to move to the next step – prevention and ultimately prediction. While you can’t prevent every defect, you can minimize scrap and wasted batches, improve yield, and product compliance, improve Overall Equipment Effectiveness, ensure supply chain safety, and reduce errors by using data from unexpected events to predict and prevent future problems while identifying opportunities for improvement across the extended enterprise.

“If history repeats itself, and the unexpected always happens, how incapable must Man be of learning from experience.” ~ George Bernard Shaw, Playwright

Is your organization ready to learn from history and use the unexpected to drive continuous improvement?

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The post Pharmaceutical Organizations: Managing the Unexpected! appeared first on Pilgrim Quality Solutions Blog | Quality Management Blog.

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Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

The standard supply chain within the Pharmaceutical industry is complicated. It is subject to strict regulations and industry best practice standards. In addition to heavy oversight from regulators, industry, and consumers, the intricate structure of the Pharmaceutical supply chain, as well was its global nature, add to its complexity. The emergence of India and China, where there are now many excipient, API, and CMO suppliers, exemplify that global nature. This expansion on the global stage adds another serious layer of complexity. With distance, comes risk — the risk that something could go wrong not only in manufacturing, but in transit.

With so much at stake, a manufacturing organization must focus its vision from the very beginning.

Understanding Regulations and Standards

There are many regulations and standards to reference regarding the Pharmaceutical supply chain. Below is a list of just a few that cite the need to start at the beginning by first knowing your suppliers, and their suppliers.

  1. ISO 9001:2015 Section 8.4
  2. ICH Q10 – Pharmaceutical Quality System (section 2.7)
  3. ICH Q9 – Annex II.5 Quality Risk Management as a Part of Materials Management
  4. FDA Guidance for Industry – Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
  5. 21 CFR Part 211
  6. Active Pharmaceutical Ingredients Committee (APIC)

ICH Q10 requires the use of approved suppliers and a defined supply chain. ISO 9001:2015 section 8.4 states that the organization shall determine and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. It also states that the organization shall retain documented information of these activities and any necessary actions arising from the evaluations.

Without going into the text of each regulation, it suffices to say that these regulations and standards, echo the same base requirement: the need to manage the evaluation, selection, management, and decommissioning of Suppliers which results in an Approved Supplier List (ASL).

It Starts with Supplier Life Cycle Control

The creation of an ASL isn’t an annual event. It is the result of a continuous supplier life cycle control process. To understand fully the criticality of engaging Supplier Life Cycle control, look to one of the guidances which makes the case for a defined supply chain very clear. FDA’s Guidance for Industry – Contract Manufacturing Arrangements for Drugs: Quality Agreements states, “In all cases, the Owner is responsible for assuring that drugs introduced for interstate commerce are neither adulterated nor misbranded…”. In other words, regardless of the “source” of a problem, it’s the brand owners’ problem.

For this reason alone, it is critical that each of your suppliers is properly evaluated, allowing your organization to understand each of these respective operational attributes:

  • What are their business systems?
  • Are they financially stable?
  • What do the financial analysts and market have to say about them?
  • What percent of their sales is the product or resource you need?
  • Do they have a quality system?
  • What metrics do they calculate and trend?
  • Do they have any certifications?
  • Have there been any regulatory compliance findings against the organization?
  • What is the capacity of the supplier’s operations?
  • What technology do they use?
  • Do they have a good reputation in the industry?
  • Are their product costs and distribution costs in line with the competition and your budget?
  • Physically, where are they located, and who are your points of contact?

While this list is not entirely inclusive, one can see that the purpose of a supplier evaluation process is indeed to assess and assign supplier risk. It is equally important to assess the process your suppliers use to evaluate, select and monitor their suppliers. Organizations must track and understand where raw materials, APIs, and intermediates are coming from for a fully defined supply chain.

Defined Supply Chain’s Purpose

When something goes wrong in the supply chain, regardless of where it went wrong in the supply chain, it impacts your organization and the patients it serves. Having a well-defined supply chain is ultimately about patient safety. It’s about understanding the genesis of the products you deliver to the market and how they are ultimately delivered to the market. And if something does go wrong, it’s about quickly identifying and correcting the problem, minimizing the impact on product availability, and preventing any adverse impact on the patient.

In addition to ensuring patient safety, a well-defined supply chain will reduce risk by ensuring upstream and downstream quality, aiding in your organization’s ongoing pursuit of regulatory compliance. This continuous performance also will be reflected in improved overall business metrics, such as reductions in supplier defects and supplier returns, improved in-compliance product ratios, reduced scrap and waste, and reduced re-work and improvements in first pass yield.

Reduce Supplier Risk, Reduce Organizational Risk E-book

This e-book addresses ways to reduce supplier risk in your organizations, and the role of Quality in that process.

The post Defining the Pharmaceutical Supply Chain: Start at the beginning appeared first on Pilgrim Quality Solutions Blog | Quality Management Blog.

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IQVIA

It is an exciting, and formidable, mandate – to solve the world’s healthcare challenges. To continually find new ways of delivering value and real outcomes to patients, providers, and payers. To rise to the challenge to be more precise, from clinical trials to commercialization. To make the most out of increasingly limited resources. And to minimize while maximizing success. That is what IQVIA, the Human Data Science Company, is about.

The collection of recent IQVIA blogs below take a look at the landscape and issues impacting the Pharmaceutical industry in the era of Technology 4.0. Learn more about the IQVIA perspective on the future of Pharma here:

Growth perspectives for the pharma market – According to the latest 2019 Market Prognosis publication, despite a growing global healthcare burden, pharma market growth* is expected to slow to a CAGR of 4.6% over the five years to 2023.

Artificial Intelligence and In Vitro Diagnostics: Advancing Patient Care – The in vitro diagnostics (IVD) laboratory stands at the center of clinical decision-making, because of its role in data generation. A recent study on the awareness of AI in the U.S. clinical laboratory, conducted by the IQVIA BBC IVD Solutions team, showed that most laboratory professionals have already seen some advances driven by AI in their laboratory. As a result, they expect dramatic changes within the next two to five years in both the laboratory landscape and their routine workflow.

A new (protected) future for genomic data – How breakthrough privacy protection will accelerate research and transform precision medicine.

Virtual Trials 101: Answering questions (and dispelling myths) about virtual clinical research models – Virtual trials promise to transform the way clinical research is conducted. This model delivers multiple benefits including access to larger patient populations, easier recruiting, more and better data collection, lower levels of attrition, and ultimately lower costs.

Yet because this model is still relatively new, many industry professionals are uncertain about how it works, where it’s appropriate, and what it means for site staff. To address these concerns, we’ve answered the most common questions when it comes to virtual trials.

 

Smart Quality Management E-book

Learn how you can build a business case to gain organizational support for your Quality 4.0 initiatives.

The post The Future of Pharmaceuticals appeared first on Pilgrim Quality Solutions Blog | Quality Management Blog.

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