Validation of 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 protocol has been produced in response
to several hundred
suggestions we received in our ‘Suggestions
Section’. It has been carefully
designed to make it the preferred choice for Process and Laboratory
equipment. It is an interactive, fully detailed, sixty three page
runs to approximately seven thousand words. It is presented in 'MS
facilitate ease of final editing by the end user. It has become a very
Protocol (Issue-2). -- $159.00
A recent warning letter demonstrates just how few companies use a Gap Analysis to validate that they are compliant. CAPA discrepancies continue to be the biggest single source of problems. However the daddy of them all recently has been a well known company that had carefully documented the levels of experience and educational standards required for various GMP sensitive roles (In accordance with GMP), only for the FDA to find the persons in these jobs were not qualified properly. (click here to read)
Do use a Gap Analysis and avoid these embarrassing events. Gap Analysis Tool (Issue 2.) -- $115.00
Validation Risk Assessment (Issue10.) -- $125.00
This popular Validation Risk Assessment (VRA) has now been edited and enlarged to include Part 11 assessment tables for you to use in classifying which of your predicate records require to be stored in compliance with 21 Part 11, and which do not. It also includes an Excel spreadsheet to allow you to establish a permanent record of all such judgements, as is now mandated by the regulatory authorities.
Are you ready for an inspection?
With HEPA filters, the manufacturers recommended dirty filter change pressure differential (PD), is only correct if the filter is used at exactly the the same air flow as the makers specify. If there is any digression (there is often as much as 50% digression) then the makers PD must be corrected. If this is not carried out you can compromise the integrity of your room / machine pressure regimes. As you are no doubt aware this would be a very serious state to be in. There are also health and safety problems that can arise, if personnel are not getting the air flow protection that is sometimes designed into the system. This test script is not in the standard OQ, and is only available here as a download. Regulators ask to review your writen justification for these filter change PD's; make certain you have them.
Purchase your copy of this test script now at Special Price of $16.00.