The number of regulations is steadily increasing, and compliance efforts allocate more resources and bigger parts of the revenue. GMP quality consulting in pharma prioritizes the Digitization of the Validation Process, either the validation of GMP production equipment or Computer System Validations. The digitization of both validations are effective measures to increase the process efficiency and reduce cost and efforts.
Data-driven and paperless validation processes are an essential first strategic step to reduce business risks and process costs while improving and ensuring the compliance with pharma regulations.
In a second step, Al and IoT can be integrated in the computer system validation processes, which enables Pharma 4.0.
Digital validation workflows
The initial implementation of a paperless validation process in GMP regulated environments enables up to 50% more efficiency than paper-based validation. Cost, effort reductions and time gains, which helps the GMP organization to focus on their business objectives while yet increasing the level of compliance.
Compliance risks of regulated GMP computer system-based environments can cause
Core workflow and documentation requirements of a paperless validation process encompasses
- Acceleration of document handling, processing and approving according to 21 CFR part 11 resp. EMA chapter 11 to decommission traditional paper-based validation life cycles
- Electronic routing and processing of documents to responsible users to ensure execution in quality and compliance
- Automatic notification on due tasks to ensure their execution in time and scope
- Standardization of document templates, qualification scripts & tests to accelerate approval cycles
- Automated generation of the traceability matrix access requirements, functional and design specifications and test cases
- Controlled review, change and approval process across the validation documentation
- Risk assessment and management on the requirements and computer system level
- Centralization and administration and change management of the entire validation documentation
- Support of periodic document reviews and re-validation according to the validation life cycle
GMP quality consulting in pharma and customer experiences
Just these core workflow process improvements of the first Digitized Validation realized by GMP quality consulting in pharma add up to a ~50% higher efficiency of the overall validation process. The feedback on GMP pharma customers to their paperless validation processes experience confirms:
- “Turnaround time of documents approval is significant faster”
- “Electronic execution accelerates the whole process”
- “All validation tasks are being managed more efficiently and faster”
- “Requirements trace matrix generation is now being automated”
- “Document retrieval is instantaneous”
- “Inspections being handled more accurate, complete, and show compliance”
intilaris LifeSciences – LinkedIn