• Initial definition of GMP-conform operations in a quality plan configured to your requirements in co-ordination with your quality assurance department
• Incorporation of all validation operations in a quality report at the end of the project for creating the transparency that is necessary for a master validation report and for inspections
• Implementation of your requirements taken from the specification in a custom-tailored spec sheet
• The controlled path from the spec sheet to specified and thoroughly tested software modules, from which the whole machine control system is comprised
• Extensive testing of the computer system on the finished line as documented evidence that customer requirements have been implemented and as the basis, for instance, of operational qualification (OQ)
• Traceability of the critical requirements from the specification up to the test using a requirement/test matrix.

Your advantages:

• Your machine operation requirements are implemented exactly
• You receive controlled software that has high transparency and excellent and global documentation for planning, specification, testing and summarising
• We exist you to pass future inspections.

In addition to this prospective computer validation, we also have extensive experience in subsequent "retrospective" validation of your older machine control systems