Transitioning to Digital Work Instructions
- Client: Global Japanese pharmaceutical company – European lab environment
The Challenges
Laboratory processes relied on printed Word-based forms, filled in by hand—error-prone, hard to analyze, and unscalable. The goal: establish a fully digital, GxP-compliant, 21 CFR Part 11–compliant system.
The Solution
Smart Document System<sup>(c)</sup> was deployed to quickly digitize the existing work instruction templates. Specific form fields within the templates were configured with predefined target values, enabling numerous automated calculations. As a result, processes run seamlessly in the background—without requiring user intervention or the need to open additional systems. The ability to independently further develop work instructions provides maximum flexibility for the customer. Audit trail functionality and intelligent version control support and reinforce this process.
The Result
All data entry is now carried out via tablets. The final PDF files include a complete audit trail with timestamps and user actions. The customer benefits from a fully digital, standardized, and highly automated laboratory process chain that significantly enhances data access, traceability, and data availability for analytics and AI evaluations.
