FAT_test_plans

Validering og dokumentation 

Vi kan levere præcis den type dokumentation du har behov for til din validerings process

Validerings dokumentation

 

 

  • LSS tilbyder tilpasser validerings dokumentation iht. cGMP og GAMP 5 regulativer
     

  • Dokumentationen certificere at udstyret er designet, fremstillet og fungerer i henhold til dine URS krav.
     

  • Validaeringspakkerne er sammensat af DS, DQ, IQ/OQ and FMEA risiko analyse

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

Vil du vide mere om vores løsninger til vials og ampuller?

Så kontakt vores eksperter

Peter B. Hansen
Peter B. HansenProject Sales Manager+45 8711 0824 Se LinkedIn-profil
Jens Heidemann
Jens HeidemannProject Sales Manager+45 8711 0811 Se LinkedIn-profil
Jan Vinther
Jan VintherProject Sales Manager+45 8711 0809 Se LinkedIn-profil
Søren Andersen
Søren AndersenProject Sales Manager+45 2373 3901 Se LinkedIn-profil