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The easing of the requirements detailed in 21 CFR Part 11, has lead to other requirements being mandated. These requirements are all detailed in our up-dated Validation Risk Assessment document. The Validation Risk Assessment (VRA) is now a pretty essential document to have and use. To learn more about this Validation Risk Assessment contents, click here; VRA To purchase a ready to use Validation Risk Assessment document, click here; VRA It is a mandatory requirement that certain aspects of this assessment are documented and held as a regulatory required record. These are; Does the software require full life cycle validation? Does the software produce records that must comply with 21 CFR Part 11? If the data is definitely predicate data; how is compliance achieved? The answers to these questions are required to enable the Validation Plan to provide sufficient information to the protocol writers, to enable them to define the correct content for the IQ/OQ/PQ protocols. The VP is then used by the protocol writers as the official mandate for protocol content New Documents This Month. 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. |