Product Engineering Services & Solutions blending Applied Sciences with Technologies

Case Study: Computer System Validation

Client

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.

Background:

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.

Challenges:

  • Client started development of LES and CSV in parallel, therefore requirements kept on changing for CSV.
  • Multiple dry run iterations of OQ scripts required as LES configuration specifications and subsequently OQ requirements changed frequently.
  • SOP to user requirements were not elaborate enough.
  • Inadequate planning for availability of instrument/simulator for testing purposes resulted into overruns.

Solution

Overview:

B.A.T has expertise in Analytical Laboratory systems development, testing and CSV. Our strong domain knowledge enabled us in understanding the requirements as well as the challenges, ensuring satisfactory achievement of business objectives behind this CSV program. The first iteration of CSV 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.

Details:

  • The initial scope for 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/updation in adherence to customers CSV processes and formats using B.A.T. methodology backed by CSV requirements management tool.
  • 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 documentation as per Good Documentation Practices.
  • OQ Summary Report generated and documented.

Benefits

Business:

  • Predictable budgeting for CSV because of
    • a. Ability to optimize entire process of CSV execution, resource deployment and utilization by ensuring on-demand availability of highly qualified and trained professionals with relevant skill sets that include Analytical Laboratory, Informatics, CSV and Software Testing.
    • b. Transparent & reliable reporting to client/customer ensuring full visibility into project progress.
  • Cost Savings because of
    • a. Substantial Effort and Time Optimization achieved by re-usability of artefacts.
    • b. Timely Test Case Authoring and Execution in-spite of software system availability issues.
    • c. Reduction in on-site presence
  • Better Regulatory Compliance
    • a. Adequate OQ documentation is an enabler.

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Case Study

Domain : Regulatory Compliance

Type : Knowledge and Consulting

Client

Challenges

Solution

Benefits

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