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 (Bio Analytical Technologies) provided the Computer System Validation (CSV) services as per applicable regulatory guidelines for LES. The scope of the program included with SOP’s for preparation of reagents, standards, instrument calibration, QA processes for API and drug formulations.


  • Client started development of LES and Computer System Validation (CSV) in parallel, therefore requirements kept on changing for Computer System Validation (CSV).
  • Multiple dry run iterations of OQ scripts requires LES configuration specifications which often results in the frequent changes in OQ requirements.
  • SOP for user requirements were not elaborate enough.
  • Inadequate planning for availability of instrument for testing purposes resulted into overruns.



The first iteration of Computer System Validation in a plant 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.


  • The initial scope for Bio-Analytical Technologies (B.A.T) was writing OQ and PQ scripts, as well as OQ execution. This scope expanded to translating SOP’s to requirements, LES development and testing of LES.
  • Carried out detailed study to understand the requirements encompassing User Requirement Specification, System Requirement Specification, Functional Risk Assessment and Standard Operating Procedures (SOP).
  • Test case design based on functional risk assessment including Challenge Test Scenarios as appropriate.
  • Handled requirement changes through Change Management Process by identifying, tracking and resolving discrepancies.
  • OQ and PQ test case creation/updating in adherence to customers Computer System Validation processes and formats using B.A.T. methodology.
  • Scheduled joint review meetings with all the stakeholders to arrive at consensus on testing strategy/approach and prepare guidelines based on the same.
  • OQ test case execution, evidence capture, OQ Summary Report generated and documented as per Good Documentation Practices.

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