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Do we have to validate ‘off the shelf software’? Do we have to validate ‘freeware’?
No matter how often we answer these questions; every week they are reappear in our queries section. The simple answer is; there is no way you can shirk or shift your company’s regulatory requirements. Quite simply; your company is at all times responsible for validating any and all software used in producing a regulated product. Whether your software (off the shelf or otherwise) is to be used in a medical device or as a production tool in producing a regulated product and can in any way, affect the quality, efficacy or records of that product, pretty similar regulatory requirements exist. In this guidance document a summary of a Risk Assessment (RA) is given. Follow this and you will be able to assess the degree of validation that the regulators expect you to have in place. This guidance document indicates where minimum validation is acceptable and where it is not. Where full life cycle validation becomes a requirement, then development history of the proposed software is required to ensure quality of conception and build. This is often the major deciding factor on what ‘off the shelf’ or ‘freeware’ software (if any) can and can’t be used. Some of Our Current Fast Moving Documents. Software Validation SOP (Issue-2) -- $22.00 Software Validation Master Plan (issue-2) -- $115.00 Software Validation Risk Assessment (Issue 2) -- $125.00 Software User Requirements Specification. (Issue 2) -- $115.00 Software Validation Plan (Issue 2) -- $89.00 Software Design Qualification. (Issue 2) -- $89.00 Software Installation Qualification. (Issue 2) -- $89.00 Software Operational Qualification. (Issue 2) -- $89.00 Software Performance Qualification. (Issue 2) -- $89.00 Software Validation Package (Issue 1) -- $699.00 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.
Combined IQ / OQ Protocol. 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. The SOP for Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q. |