SOFTWARE VALIDATION.

It has to be understood that all validation starts with a requirement and more than likely a whole bunch of requirements together known as the User Requirements Specification (URS).  You require a software program; to do what, why, where and when?

Validation ends with the PQ that verifies that the software you have procured or written; satisfies all your requirements as detailed in your URS.

(i.e. no URS equates to no content for your PQ = flawed validation).

In between are the Validation Plan (VP), Validation Risk Assessment (VRA) and the Design Qualification (DQ).  The regulatory authorities require these documents to be in place with the dates for content approval and execution to running consecutively.

The devil is in the detail:  The User Requirements Specification (URS) must be fully detailed and include all aspects of procurement; such as usage, maintainability, calibration, cleaning, utility requirements, facility requirements, user training, support documentation, support engineering drawings, software programs and all the attendant SOP’s that are required in the execution of the these and all other GMP specified tasks.  There must be no surprised or shocks when the machine/software arrives, all requirements (yes even the most obscure details) must be anticipated and engineered for. 

If you tackle the URS in a professional manor with your colleges and peers, you should develop a sound company reviewed and approved URS that will guide, develop and produce a comprehensive URS; that is worth its weight in gold.

The FDA have stated that over 70% of validation problems stem from the procurement not being properly detailed and or managed.  Get the URS correct and you are well set to execute your validation task smoothly, compliantly, on time and on cost. 

Your risk assessment (this RA is used only to ensure validation scope is adequate) must authorize your whole approach the validation of the software under qualification.  Software used in equipment can normally be validated by testing the functionality of the equipment then ensuring all GMP requirements for this class of software are complied with.  However software that is designated (by the RA) as Critical; requires to be subjected to full life cycle validation (FLCV).  The content of the respective IQ, OQ and PQ protocols will reflect the different intensities of the validation process. 

The requirement for three batches in PQ is not set in stone and you can do what ever you want to do; providing you have a sound compliant and peer approved documented justification for your choice of action.  This justification along with all responsibilities and policies must be documented in the Validation Plan (VP) for this task. 

It must be getting rather obvious now that the documentation required for compliant validation (and expected by the regulators) does indeed form a chain, with each link firmly supported by the previous link and forming a sound footing for the next link. 

URS – VP – VRA – DQ – IQ – OQ – PQ.

Click here and go to bottom of page:            Software Validation Package (Issue 1) 10000770

Regards Alex

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Climatic Zone Validation Package-1 (Issue 1)
$1525.00
10000399

This package is complete with all the validation documentation you require to validate the climatic condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP) the Validation Risk Assessment (VRA) the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are 10 highly accurate and easy to use data loggers ready to monitor and record close to 17K (each) parameters over what ever time base you select. This is now the simplest most expedient and most cost effective method of validating the climatic condition within any climatically controlled zone.
Includes VP, VRA, IQ, OQ & PQ. Along with 10 RH & Temp EL-USB-2 data loggers.

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Climatic Zone Validation Package-2 (Issue 3)
$2575.00
10000398

This package is complete with all the validation documentation you require to validate the climatic condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP) the Validation Risk Assessment (VRA) the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are 10 highly accurate and easy to use data loggers ready to monitor and record close to 17K (each) parameters over what ever time base you select. This is now the simplest most expedient and most cost effective method of validating the climatic condition within any climatically controlled zone.
Includes VP, VRA, IQ, OQ & PQ. Along with 20 RH & Temp EL-USB-2 data loggers.

Combination IQ/OQ/PQ Protocol.