Validation of all Critical Software.

Validation of product software requires a document chain that starts in the initial stages with extraction from the concept documentation of sufficient information to development a robust, comprehensive and inclusive User Requirements Specification (URS).  This URS must be reviewed and approved by all parties that will be involved in the procurement, installation, training, use, maintenance, calibration and regulatory compliance, to ensure that all the requirements associated with the successful qualification of the equipment have been identified, documented and provisioned for.

Once the equipment is in the qualified state; all subsequent modification proposals must follow the same route and intensity of investigation, identification and documentation, prior to being approved for execution.  Once approved has been attained; a Validation Risk Assessment (VRA) must be used to set and justify the scope of revalidation that the incorporation of the modification demands.

Every month there is fresh evidence; in the form of FDA Warning Letters, that scream out that many companies are either not aware of this requirement, or perhaps opt to ignore it.  A sample warning letter is reproduced below. 

Validation of software was not performed. Specifically, the Integrated analyzers in commercial clinical use have either a VME Motorola ICS board or a PowerPC board running the software. When validating the software version change; your firm did not do system integration testing on the VME board. Neither did it conduct a code review of the software change for the VME board. The modified version was then released to the field in late 2009. It was subsequently determined that this software had a bug introduced by the change and a recall was necessary in February 2010.  (FDA Archives)

The above Warning Letter is seriously bad news for any company.  To recall (in an accountable manner) every single item of product from warehouses, shippers, distributors and retailers, world-wide is an extremely costly operation.  However if the product is an implanted device the costs may well escalate exponentially. 

It bodes well to always be aware that software to be used in any;  regulated manufacturing process, which has been rated (using an official VRA) as critical to the quality of that process or predicated records of that process, requires to be subjected to the same procedure listed above.

Combination IQ/OQ/PQ Protocol.
This combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand-alone equipment. It is an interactive, fully detailed, sixty three page protocol that runs to approximately seven thousand words. It is presented in 'MS Word' to facilitate ease of final editing by the end user. It has become a very popular document.