Warehouse Climatic Validation.At last a simple none disruptive method of carrying out climatic mapping for large or medium sized warehouses and or zones. No more cables all over the place; being trampled upon or being snagged or damaged by fork lifts. No more disgruntled warehouse staff. No more having to interpret channel colours on multi-pen recorders. What a problem that used to be; using twenty channel recorders all channels with a different colour parameter print out. Well that was what the recorder manufactures stated, in actual practice when colours printed on top of colours it became very difficult to be certain what channel was where. Now the self-contained data logger can quietly and unobtrusively carry out the same task with the minimal usage of manpower or disruption to normal warehouse activities. The data loggers can be left mounted to shelve supports (therefore occupying no shelf space) for as long as is required. For instance the standard data logger we use and recommend could log temperature and humidity parameters every 30 minutes; for one year. It is a requirement that your warehouse validation verifies that the specified internal storage conditions are maintained regardless of external seasonal climatic variations. Where these seasonal variations include extremes of heat, cold and or humidity, your validation studies must verify that the specified internal warehouse climatic conditions were maintained throughout all of these variations. Our latest offer below includes a complete suite of validation protocols along with ten (Package-1) or twenty (Package-2) data loggers. These will enable you to tackle most climatic mapping requirements, simply and expediently. Bottom of Form Climatic Zone Validation Package-1 (Issue 1) This package is complete with all the validation documentation you require to validate the climatic condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP) the Validation Risk Assessment (VRA) the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are 10 highly accurate and easy to use data loggers ready to monitor and record close to 17K (each) parameters over what ever time base you select. This is now the simplest most expedient and most cost effective method of validating the climatic condition within any climatically controlled zone. Bottom of Form Climatic Zone Validation Package-2 (Issue 3) This package is complete with all the validation documentation you require to validate the climatic condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP) the Validation Risk Assessment (VRA) the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are 10 highly accurate and easy to use data loggers ready to monitor and record close to 17K (each) parameters over what ever time base you select. This is now the simplest most expedient and most cost effective method of validating the climatic condition within any climatically controlled zone. 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.Combined IQ/OQ/PQ Equipment Protocol (Issue-2). -- $159.00 SOP Security.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.
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