Going forward, b+b Automations- und Steuerungstechnik GmbH is able to supply its customers with the appropriate IT validation documents for their software solutions. End customers are therefore able to independently and reliably perform a GxP-compliant validation of their software.
The GMP service provider gempex took on a special assignment on behalf of b+b Automations- und Steuerungstechnik GmbH. B+Bdevelop software and offers complete solutions in the areas of automation, serialisation and labelling:
b+b initiated a pilot project to offer a validation package with standardised documents, enabling customers to reliably perform a GxP-compliant software validation themselves.
In addition to reviewing the software development concept for GAMP®5-compliant documentation, the focus was on preparing the documents for software validation by the end customer. Exactly coordinated standard templates are the result, covering the following topics:
- User requirement specification
- Functional specification
- Software design specification
- Risk assessment
- Installation qualification
- Operational qualification
- Traceability matrix
The advantages for the end customer are readily apparent: after a quick revision, the documents can be completed and approved through the internal QM system. Internal resources are conserved, and the need to engage external help for the software validation is alleviated.
Learn more about the project here.
We are also happy to answer your questions at booth 36 during PharmaTechnica in Düsseldorf, the trade show accompanying the Pharma Congress on April 9th and 10th.