The EU GMP guidelines require detailed documentation of transfer plans and reports.
The AUTOMATION
Automation increases process efficiency and system availability, while at the same time 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 thanks to the automatic recording of
production data. Relevant production data and resources are available at the right time. Even the smallest deviations are detected, 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 identified. The optimization 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-oriented proposals.
the 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 practicality and reliability. It is then verified that the computer system used functions correctly after modifications, modernizations 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 provides inspection reliability through documented measures and various tests with a
100% life science focus.
Contact at Pitzek GMP Consulting
Head of Engineering & Automation
Arvid Duchardt
Mobile: +49(0) 151 511 192 24
