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.
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.
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.
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.
PSC did multiple projects with this client for their new product development. This included:
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.
