About this Project OBJECTIVE Watson 7.6.1 system implementation and upgrade, including new servers, disaster recovery, computer system validation, and business process remediation. SERVICES PSC Biotech® is helping our client, a global leader in testing and laboratory services located at St. Louis, with a Watson 7.6.1 system implementation and upgrade, including new servers, disaster recovery, computer system validation, and business process remediation. PSC had to support an aggressive project schedule and a global implementation team to ensured the project milestones were met with n ..read more

About this Project OBJECTIVE Commissioning of Utilities, EMS, Electrical and HVAC for the Clients Facility to Meet Certain Criterion SERVICES PSC® performed commissioning of utilities, EMS, Electrical and HVAC for this clients facility. The team worked on the environmental monitoring system (EMS): Monitoring for each individual room, at the formulation standpoint. Each room was required to meet a certain criterion for how much pressure was in there. They also were in charge of making sure each room is in a certain environment that ensures the room and people are safe, and nothing wou ..read more

About this Project OBJECTIVE  Preparation for regulatory agency inspection services  SERVICES Our client, a research foundation in Saskatchewan, brought PSC Biotech on for Quality Assurance services. The client was seeking GLP lab accreditation to aid in their therapeutic development programs. PSC Biotech was able to oversee, arrange, conduct, and report on audits of cGMP facilities, nonclinical systems. PSC Biotech is responsible for overseeing the implementation of a  pharmaceutical quality program to support the client’s agency inspection prepara ..read more

About this Project OBJECTIVE Perform Supplier Audits in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices.  SERVICES This client utilizes PSC® Biotech’s professional services group to perform Supplier Audits. The main focus was to assess the quality systems and records to assure that the materials produced are made in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices to determine if the operation is in a “state of control”. The PSC Biotech® Services Project Manager and S ..read more

About this Project OBJECTIVE CSV Support Projects SERVICES PSC® executes approximately 40 CSV projects per annum across the full spectrum of systems (bench-top instruments through enterprise applications such as ERP, DCMS, and QMS. The PSC® Service Lead manages account (budgets, resources) and provides CSV Subject Matter Expert input. For various CSV projects, PSC® has provided the client with validation plans, risk assessment, HPQC Support, and test script development. Additionally, PSC® has developed installation/operation/performance qualification protocols for the client. HEATHER KELL ..read more

About this Project OBJECTIVE CQV – Qualification of AQUATHERM SWS sterilizer (Syntegon) SERVICES The client engaged PSC to initiate the validation and qualification of a AQUATHERM SWS sterilizer (Syntegon) with a chamber of approximately 2500 ft3. Laboratory and Pharmaceutical Manufacturing equipment validations play a vital role to ensure the quality and effectiveness of the equipment being used for the development of manufactured products. Our team of engineers efficiently completed the tasks of performing qualifications for the AQUATHERM SWS sterilizer (Syntegon). These tasks incl ..read more

About this Project OBJECTIVE Registration of Animal Product SERVICES This project is ongoing, PSC Biotech® is helping our client located in St. Louis with registration of their animal product (vaccine) in 3 countries, UK, Australia and New Zealand. This project involved many critical processes such as providing support in terms of building out a regulatory strategy for the registration of the product, developing formats for submission of critical quality, safety and efficacy data and authoring CTD Modules 1-5 for submission to the respective Regulatory agencies as also prov ..read more

About this Project OBJECTIVE Calibration Software Risk Assessment, Qualification Protocols, and Validation Plan Development.  SERVICES PSC Biotech® performed a Risk Assessment of critical calibration software functionalities and developed a Validation Plan. Our consultant developed configuration specifications, performance qualification protocols, and test scripts for specification of testing of critical calibration software activities. They completed gap assessments or vendor installation qualification, operational qualification, user requirements, and traceability matrix ..read more

About this Project OBJECTIVE The goal of this project was to provide audit services as per GMP guidelines for the client manufacturing facility. SERVICES PSC Biotech executed a 2-day GMP audit in compliance with 21 CFR 211 and 21 CFR 212. A PSC Senior Auditor performed the audit, prepped, and generated a comprehensive report of the project. PROJECT SUCCESS This project was completed successfully as per client specifications and in the expected time for completion ..read more

About this Project OBJECTIVE Perform Supplier Audits in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices.  SERVICES This client utilizes PSC® Biotech’s professional services group to perform Supplier Audits. The main focus was to assess the quality systems and records to assure that the materials produced are made in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices to determine if the operation is in a “state of control”. The PSC Biotech® Services Project Manager and S ..read more