FAT_test_plans

Validation documentation services

We can supply the scope of documentation you need for your validation process

 
  • LSS offers tailored validation documentation packages according to the cGMP and GAMP 5 regulations
     
  • The documentation certifies that the equipment has been designed, built and operates according to your URS requirements
     
  • 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

Would you like to know more about labelling solutions for the pharmaceutical industry?

Contact our experts
 
Søren Andersen
Søren AndersenProject Sales Manager+45 2373 3901 See LinkedIn profile
Jan Vinther
Jan VintherProject Sales Manager+45 8711 0809 See LinkedIn profile
Frank  Qvortrup Thygesen
Frank Qvortrup ThygesenProject Sales Manager+45 8711 0811 See LinkedIn profile
Peter B. Hansen
Peter B. HansenProject Sales Manager+45 8711 0824 See LinkedIn profile