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How this idea of Paperless Validation evolved

How this idea of Paperless Validation evolved

Introduction

To be begin with, I was working in a CRO for IT department. We used to develop custom application, support existing applications like DMS, LIMS. ERP Etc. I got an opportunity to develop a laboratory information management system (LIMS) for a clinical lab, which needs to be validated before we implement. I was involved in end-to-end validation and deployment. During this process, i was able to understand the end to end flow on how an URS getting realized to a custom application right from development, testing, validation, documentation, deployment & go live.

Development Approach to implement CFR validation

Since it was a custom in-house application (under GAMP5 category), we started with URS & Risk assessment. Followed by drafting Test cases and categorizing as IQ, OQ and PQ.  V Model validation process was followed in a manual way.

  • Defining URS
  • Change control Initiation & Approval
  • Risk assessment
  • Development & Testing
  • Preparing Validation Master plan
  • Execution of Test cases (IQ OQ PQ)
  • Implementation , Signatures & Approval
  • SOP draft and Approval
  • Training to various team members based on their roles and access rights.
  • Validation Summary report
  • System release certification by functional Head
  • Closure of Change control
  • Post implementation Support
  • Backup & DR site setup

GAMP5 validation cycle

Understanding the process of validation was initially difficult. Thanks to my team members who helped me the pharma perspective of validation. Prior knowledge on manual testing, automation testing, software validation and verification helped me a lot during the implementation cycle.

 

 

 

 

 

 

 

 

Practical problems in Manual way.

Manual validation issues

  • Mapping URS vs FS, DS, Test scripts to get a traceability matrix was taking more time.
  • Person dependency while test case execution on review and approval.
  • Human errors while documentation.
  • Sequential way of project execution. Adaption of agile parallel way of execution and implementation was a challenging tasks

I was bit surprised to see 100s of pages printed, reviewed by different departments and physically signed with a date time stamp. This was the driving factor to develop such system to replace a manual paper based system to a workflow based automated system in electronic way. Click here to know more.