Validation documentation services
We can supply the scope of documentation you need for your validation process
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LSS offers tailored validation documentation packages according to the cGMP and GAMP 5 regulations
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The documentation certifies that the equipment has been designed, built and operates according to your URS requirements
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The validation packages are composed by DS, DQ, IQ/OQ and FMEA risk analysis
1. Design Specification
- Design specification
- Design Review with customer
2. Basic Documentation package
- Quality Activity Plan
- Design Specification incl. design review
- URS – DS cross reference list
- FAT & SAT Test Protocol & Report
3.Extended Documentation package
- Quality Activity Plan
- Design Specification incl. design review
- URS – DS cross reference list
- FAT & SAT Test Protocol & Report
- IQ Protocol, based on customers specification in the URS (Q or C indication)
- OQ Protocol, based on customers specification in the URS (Q or C indication)
4.Validation Documentation package
- Quality Activity Plan
- Design Specification incl. design review
- URS – DS cross reference list
- FAT & SAT Test Protocol & Report
- Validation Plan
- Risk Management Plan
- FMEA risk analysis performed according to the Machine Design Specification and the product criticality (determined by the customer).
- IQ Protocol prepared according to the FMEA
- OQ Protocol prepared according to the FMEA
- Validation Summary Report
Other solutions for pharmaceutical products
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