FAT_test_plans

Validation documentation services

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

Validation documentation

 

 

  • 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

a) Design specification 
b) Design Review with customer

 

2.Basic Documentation package

a) Quality Activity Plan
b) Design Specification incl. design review
c) URS – DS cross reference list
d) FAT & SAT Test Protocol & Report

 

3.Extended Documentation package

a) Quality Activity Plan
b) Design Specification incl. design review
c) URS – DS cross reference list
d) FAT & SAT Test Protocol & Report
e) IQ Protocol, based on customers specification in the URS (Q or C indication)
f) OQ Protocol, based on customers specification in the URS (Q or C indication)

 

4.Validation Documentation package

a) Quality Activity Plan
b) Design Specification incl. design review
c) URS – DS cross reference list
d) FAT & SAT Test Protocol & Report
e) Validation Plan
f) Risk Management Plan
g) FMEA risk analysis performed according to the Machine Design Specification and the product criticality (determined by the customer).
h) IQ Protocol prepared according to the FMEA
i) OQ Protocol prepared according to the FMEA
j) Validation Summary Report

Other solutions for pharmaceutical products

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

Contact our experts
 
Peter B. Hansen
Peter B. HansenProject Sales Manager+45 8711 0824 See LinkedIn profile
Jens Heidemann
Jens HeidemannProject Sales Manager+45 8711 0811 See LinkedIn profile
Jan Vinther
Jan VintherProject Sales Manager+45 8711 0809 See LinkedIn profile
Søren Andersen
Søren AndersenProject Sales Manager+45 2373 3901 See LinkedIn profile