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.

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 (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.

Challenges

  • 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.


Solution

Overview

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.


Details

  • 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.


In Short

Domain: Regulatory compliance
Type: Knowledge & consulting
Client: Pharmaceutical company

Synthesis Analysis On This Case

We are expertise in Analytical Laboratory systems development, testing and Computer System Validation. We have strong domain knowledge in understanding the requirements as well as the challenges and ensuring satisfactory achievement of business objectives behind this Computer System Validation program.

1. We start with abiding the guidelines as per FDA guidance for industry part 11: Electronic records & signatures, EU annexure 11: computerized systems & WHO guidelines on validation appendixes.

2. Initially create the Validation Master plan for computerized system which gives the entire information starting from Inventory document to project validation report.

3. As it was mentioned in the challenges part i.e., SOP for user requirements were not elaborate enough, we will work for the preparation of SOP’s for relevant process execution in a simplified manner.

On Business Perspective

Predictable budgeting for Computer System Validation

1. Ability to optimize entire process of Computer System Validation 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, Computer System Validation and Software Testing.

2. Transparent & reliable reporting to client/customer ensuring full visibility into project progress.

On Cost Savings

1. Substantial Effort and Time Optimization achieved by re- usability of artifacts.

2. Timely Test Case Authoring and Execution in-spite of software system availability issues.

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