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The Trials & Tribulations of Spreadsheets. In twenty years working within the regulatory compliance side of the drug and device industries, if I was asked to single out the single most abuse process in use throughout these industries, I would have to nominate the design and use of spreadsheets. Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11. If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply. Having taken Part 11 out of the great debate; what remains. The same debaters might suggest that Excel will round up calculations, and has limitations as to its mathematical abilities. This also could be true. However it is very much up to the spreadsheet designer (and reviewer) to ensure that if number rounding is allowed; it does not meaningfully affect the accuracy of the spreadsheet calculations. Similarly the same persons must validate that the formula calculation is within the capabilities of the Excel software design. We have just launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them. SOP for Spreadsheet Creation. -- $125.00 Spreadsheet Validation Package. (Issue-1) -- $525.00 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. |