Case Study: Leading Life Sciences company slashes timelines with One-Click Automation
This case study highlights how a global biopharma company automated GMP software change validation, cutting project timelines in half and improving compliance.
Overview
Under increasing pressure to improve the efficiency of GMP software change validation, the automation team at a leading global biopharmaceutical company partnered with Apperture Solutions to transform their specification and validation workflows. Initially deployed for control system elements, a solution based on Informetric’s AgileDoc System Lifecycle Management (SLC) has since been extended to cover manufacturing execution.
Prior to AgileDoc manual updates to design specifications and test plans took weeks and were susceptible to human error. With AgileDoc, the team established repeatable, validated procedures to generate redlines, update specifications, create test plans, and route them for approval—all in less than half the time for large projects, with even greater savings for routine changes.
“We use it for everything, all the time, always… Our ability to decrease project execution time has been more than worth the effort of implementation.” – Senior automation engineer
Discover the Details
See how a global biopharma leader cut validation timelines in half and accelerated production with AgileDoc.
Key Benefits of AgileDoc Automation
By automating change validation, the company achieved:
- Design Change Efficiency: Redlines, test templates, and scope of testing generated in minutes.
- Automation Engineering: Reduced manual effort across dozens of phases and modules.
- Faster Production Timelines: Large projects completed in days instead of weeks.
- GMP Compliance: Structured, validated processes ensure traceability and quality.
