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Are you worried that passing FDA regulations for your medical device are going to slow time-to-market and cause your team massive headaches?

Speed to market is an enormous competitive advantage for organizations in the device manufacturing vertical. Avoidable delays can result in hard and soft costs to your company, which include loss of competitive advantage or regulatory fines.

While the best eQMS and knowledge of regulatory requirements can help you comply with FDA cGMP, your organization may also opt for some expert assistance. Leaning on a consultant to guide you through the process can make things easier and provide peace of mind. We'll show you several strong options for FDA consultants who specialize in the medical device manufacturing industry so you can find the best fit for your company.

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There are plenty of software providers that deliver the functionality needed to help you become 21 CFR Part 11 compliant. You can meet the FDA’s requirements for electronic records and signatures by using more than one software product.

However, achieving compliance isn’t maximizing value. To move to the top of your market and position your company for future growth, you don't need adequate compliance software—you need the best software for 21 CFR Part 11.

Don't simply ask, "Which platform can help me get the job done?" Ask, "Which platform will help me get the job done fast and keep my team productive?" FDA guidance on software for electronic records and signatures is very broad, which provides organizations with an opportunity to adopt compliant software for more excellent quality management. A compliance software could offer more benefits than just helping you avoid regulatory risks, such as better collaboration, smarter document control, or better data security.

While there’s no such thing as just one “best” software for every FDA-regulated organization, there are a few characteristics common among all of the leading options for 21 CFR Part 11 compliant software. Let's take a look at the features and qualities some of the most valuable options have to offer.

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Using a quality management system specifically designed for ISO 13485 is a smart move. To get the most value from a QMS, you need a solution which is tailored to the unique needs of medical device quality management, as well as the size of your manufacturing company.

How do ISO 13485 medical device quality management systems differ from more generic solutions? How will you know when you've found a good one?

The best systems include features to meet all ISO 13485 requirements and capabilities which facilitate more efficient compliance and greater collaboration. We'll show you what to look for in an ISO 13485 QMS below so that you can move forward confidently.

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In highly regulated industries like life sciences, you have to make sure every i is dotted, and every t is crossed. The US FDA and other regulatory agencies have strict requirements for document control, training, CAPA, and other aspects of operations. Your processes must support continuous compliance, and your organization needs to be ready to respond to requests for documentation, an audit, or regulatory changes.

Ensuring your processes and procedures are compliant can feel like an overwhelming task if you're just getting started. Life sciences startups and scale-ups in the research and development phase need to create a quality management system which can scale.

We'll guide you through the steps to ensure your organization can maintain compliance and deliver exceptional, industry-leading products.

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Should you use a cloud-based FDA regulatory compliance software or host a solution on-premises?

It's a question we hear a lot.

Many companies justifiably wonder if the decision between cloud vs. on-premises software can have an impact on regulatory risk or data security. In FDA-regulated industries such as pharma and medical devices, it's wise to take a conservative approach to risk.

While software-as-a-service (SaaS) may have been a business risk when cloud computing was first introduced, cloud software has reached maturity and become significantly more secure and stable. Cloud software is quickly reaching full adoption. Ninety-four percent of organizations are using the cloud, including the majority of organizations in highly regulated industries.

Unfortunately, some companies choose on-premises software because of outdated myths about cloud risks. Comparing cloud vs. on-premises software is now like a physician asking a patient "would you like to try antibiotics or would you like to go straight to amputation?"

Let's take a look at some of the reasons companies consider on-premises FDA regulatory compliance software and how cloud solutions stack up.

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When it comes to getting regulatory approval, creativity is rarely, if ever, a good thing.

Medical device organizations have the opportunity to exercise innovation in product development and process improvement. However, creativity and innovation aren't the best approaches to take if you're creating a formal ISO 13485 Risk Management Plan.

A Risk Management Plan is intended to be a product-level document which identifies the risk activities that occur throughout your organization's product lifecycle. Risk management activities are intended to operate as living documents and receive updates each time your organization adopts new processes or controls against risk. The smartest approach you can take is simple—to create a document that's easy to use as part of your risk management file and update it frequently.

An ISO 13485 risk management document should address your organization's systems for applying policy and procedure to the various activities involved in analyzing, evaluating, controlling, and measuring risk throughout the product lifecycle. Each device is a little different, which can require some customization of this template format. However, we'll show you the major components of a great Risk Management Plan to get you started.

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What's the difference between ISO 13485 and ISO 9001?

Do we need to adhere to both or just one of them?

Fortunately, you only need to worry about ISO 13485:2016 if you're going to make and distribute medical devices. To obtain a CE marking, which indicates conformity with safety standards for products sold in the European Economic Area, medical device manufacturers must either obtain a certification with a notified body or have a quality system in place.

ISO 13485 is a quality system for the medical device industry, and it effectively covers ISO 9001 with some additional requirements.

What many medical device manufacturers fail to realize, however, is that comparing ISO 9001 and ISO 13485 is a valuable exercise. By understanding the differences between these two standards, you learn where device manufacturers need to raise the bar on quality.

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A Quality Management System (QMS) is a critical investment life sciences companies cannot ignore.

Revenue-boosting benefits of QMS software include better consistency, minimized rework, happier customers, and better brand valuation and positioning.

Achieving a quality-driven culture enables your organization to reduce unnecessary quality costs and regulatory risks, which means bringing better products to market faster.

However, to save time, money, and resources with QMS software, you need to choose the solution that fits your organization's needs. An electronic QMS (eQMS) should be right-sized to your organization's growth stage, budget, structure, and industry. Trying to adopt a QMS that doesn't fit your use case can lead to wasted cost, non-compliance, or costly software bloat from overly extensive configurations.

How do you know which QMS software can quickly provide a return on investment?

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Understanding Current Good Manufacturing Practices (cGMP) in the pharmaceutical industry can, at first, seem like trying to pick up a handful of water. It's a broad concept that is hard to hold together.

The FDA currently offers 34 distinct final guidance documents for cGMP in the pharmaceutical industry, which include requirements for process validation, data integrity, quality metrics, and countless other topics.

The FDA's definition of cGMP is accurate. The information included in a final guidance document, which typically ranges from 10-30 pages long, is comprehensive but that doesn't mean it's clear. Reading cGMP guidelines provided by the regulatory agency can leave you with a lot of questions.

If you're wondering why "current" good manufacturing practices and why "quality by design" matters, you're not alone. In this post, we'll cover the official definition for these essential guidelines in terms you can understand with insights from pharma industry experts. Read on for some extra color and context on the definition of what cGMP is, why it's important, and how to achieve compliance in your organization.

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The cost of quality in the medical device industry is probably even higher than you think.

The global impact of medical device quality assurance and failures is $36 billion, according to a recent study by McKinsey & Company, or between 7-9% of the industry's total sales revenue. Organizations collectively spend $12 billion on quality assurance and lose $24 billion on issues related to poor quality control.

Better quality assurance is a huge competitive advantage and an insurance policy against costly quality losses for organizations who are willing to invest.

Quality assurance training can improve skill and knowledge at your organization and allow you to take a more proactive approach to drive quality improvements throughout the medical device lifecycle. But how do you know which medical device QA training options are the best? As a team of medical device Quality Management System (QMS) specialists, we know which options are the most up-to-date and which are worth your time and financial investment.

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