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XXX Final Validation Report
I. Introduction............................................................................................................................................................ 1
II. XXX System description.................................................................................................................................... 1
A. Validation Documentation.......................................................................................................................... 1
B. Hardware description................................................................................................................................... 1
C. Software version description..................................................................................................................... 2
D. Dependencies................................................................................................................................................... 2
E. Storage of version........................................................................................................................................... 2
F. Residual problems.......................................................................................................................................... 2
G. Restrictions for use........................................................................................................................................ 2
III. Conclusion............................................................................................................................................................ 2
I. Introduction
This report contains the results of the validation protocol of :
XXX system,
In version :
Installed/deployed on :
II. XXX System description
Add here a brief description of the validated system.
A. Validation Documentation
List the number, title, revision, and date of all documents referenced in or used in the
validation protocol. If this report is an update to the validation of an existing system, list the
validation report that document is replacing as a reference document.
Example
The documentation of XXX validation comprises:
Computer software validation procedure Vx.x
Process Risk assessment report Vx.x
IQ Validation protocol Vx.x
OQ Validation protocol Vx.x
PQ Validation protocol Vx.x
Etc…
B. Hardware description
Target platform where the system was installed
Ou
For software that could be installed "anywhere", the HW and SW configuration prerequisites.
C. Software version description
Add here the full version number of validated software, or any identifier which allows to
identify without any doubt the version of validated software.
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D. Dependencies
Identification of 3rd party software: OS, drivers, …
E. Storage of version
Describe here where is the master of the validated version.
EG : in a software configuration management tool, on a shared directory, on a CDROM stored
in Quality Department…
F. Residual problems
List residual anomalies or non-closed non-conformities.
Add justification proving that they don’t impair the conformity of the process(es) where
software is used.
G. Restrictions for use
Restrictions of use are possible when bugs or non-conformities are not closed.
III. Conclusion
The system is :
X Compliant
Compliant with reserves
Non compliant
with requirements of quote an input document containing user requirements and with
normative and regulatory requirements quote applicable regulations and standards.
Compliant: recorded results are compliant and anomalies are closed. Residual anomalies
don’t impair the conformity of the computerized system or of the process.
Compliant with reserves: one or more recorded results are not compliant but the
computerized system can be put in service with workaround solutions. Provided that
workaround solutions are effective, residual anomalies don’t impair the conformity of the
computerized system or of the process.
Non-Compliant: one or more recorded results are not compliant. Residual anomalies may
impair the conformity of the computerized system or of the process
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