Manual Validation Pain Points – An Insider Story
To be begin with, I was working in an IT department of CRO organization. We were tasked to develop custom applications and provide support to existing applications like DMS, LIMS. ERP etc. During that tenor, I was involved in developing a Laboratory Information Management System (LIMS) for the clinical lab of the organization, which needs to be validated before put into production. I had the opportunity to involve in all end-to-end cycle of software development, and validation of the software before it was put into production.
Development Approach to implement CFR validation
Since the LIMS application was custom-built matching our organization requirement (GAMP5 category), we had started with User Requirement Specifications (URS) & Risk Assessments. Following, the draft test cases with the categorization of IQ, OQ and PQ were developed. In absence of software solution, the entire validation effort carried in a paper based system with traditional v-model project approach.
Understanding the validation process was initially difficult for me. Thanks to my team who helped me to understand pharma perspective of the validation. Prior knowledge on manual testing, automation testing, software validation and verification had helped me a lot during the implementation cycle.
The validation project had the following key components or deliverables:
- User Requirements
- Change control Process
- 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 roles.
Validation Summary Report (VSR) - System Release certification by Functional Head
- Closure of Change Control
- Post Implementation Support
- Backup & DR site setup
Issues with paper based Validation process
- Paper Records: I was bit surprised to ascertain 1000s of pages were printed, reviewed by different departments and physically signed with a date time stamp. This was the driving factor to develop such system to replace the paper based system to a workflow based system with electronic records and e-sign.
- Document Management: In absence of organized system, document storage and retrieval was not an easy task, Example: Test case execution Review and approval process consumed more in the paper based system. A software solution with centralized document repository could have helped better in this situation.
- Reusability: Everything needs to be reproduced, no option to reuse in the manual way of executing validation project.
- Traceability: Creating a Requirement Traceability Matrix (RTM) was not an easy task and consumed lot of effort as linking URS with other deliverables done in a manual way.
- Project Execution: Sequential way of project execution. Adaption of agile parallel way of execution and implementation was a challenging task in the paper based system.
GoVal is a comprehensive validation management system that can address all the issues in the paper based manual validation process. With GoVal, the organization can implement 100% paperless validation system that can enable them to transform to digital way with electronic records, e-sign, automated workflow for review & approval and audit trail. With intuitive user interface and array of features, GoVal can help the organization to increase production and fulfil regulatory compliances (FDA CFR Part 11 and EU Annex 11).
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