Case Study: Computer System Validation
One of the India’s top ranked pharmaceutical company that offers its products to various therapeutic areas such as cardiology, neuro-psychiatry, gastroenterology, anti-infective, diabetology and dermatology. Its manufacturing units are situated in India, United States and Brazil. Their major product range consists of generics, branded generics, specialty products, over-the-counter (OTC) products, anti-retroviral (ARVs) and APIs.
The client made a business decision to achieve paperless Analytical QC laboratory. Pharma being a regulated industry has tremendous importance towards processes, records and audit trails hence client migrated from existing paper based system to Laboratory Execution System (LES) based on a product from a world leader in laboratory informatics. B.A.T provided Computer System Validation (CSV) services as per applicable regulatory guidelines for LES. The scope of the program included SOP’s for preparation of reagents, standards, instrument calibration, QA processes for API and drug formulations.
B.A.T has expertise in Analytical Laboratory systems development, testing and Computer System Validation. Our strong domain knowledge enabled us in understanding the requirements as well as the challenges, ensuring satisfactory achievement of business objectives behind this Computer System Validation program. The first iteration of Computer System Validation in a plant also became guideline to improve planning and execution in the subsequent plants. Except the OQ execution and customer reviews all activities like development, testing of LES, script preparations and dry-runs were carried out at B.A.T. premises.
Domain : Regulatory Compliance
Type : Knowledge and Consulting