Data Integrity – Requirements in the pharmaceutical industry
The EU GMP guidelines require detailed documentation of transfer plans and reports.
Automation increases process efficiency and system availability, while also improving quality and safety in the pharmaceutical industry.
A seamless, digitally recorded and legally compliant workflow is perfect for traceability and counterfeit protection. The error rate is significantly reduced by the automatic recording of production data. Relevant production data and resources are available at the right time. The smallest deviations are recognised, so that early, controlled intervention by the operating personnel is guaranteed.
In addition, recorded data from various systems is included in a performance check and potential for improvement is uncovered. The optimisation of process automation enables user-specific and predictive maintenance. For Pitzek GMP Consulting, it is very important to consider the entire life cycle of a system and to identify solution-orientated proposals.
COMPUTER SYSTEM VALIDATION PLAYS A MAJOR ROLE IN THIS
Computer validation is the documented testing of software or a computer system and provides manufacturers of pharmaceutical products with documented proof that computer-controlled or automated systems deliver consistent performance in compliance with specified regulations.
The software is tested for practical suitability and reliability. It is then verified that the computer system used functions correctly after modifications, modernisation or new planning and is suitable for the purpose for which it is used. Automated systems are generally tested and validated in accordance with US and EU regulations. This gives you inspection security through documented measures and various tests with a 100% life science focus.
Contact at Pitzek GMP Consulting
Head of Automation/CSV