Radio and Magnetic Interference.


RFI / EMI and FDA Validation.

IQ/OQ and combined IQ/OQ/PQ Validation protocols have now been updated to reflect the current regulatory expectation for Radio Frequency and Electro-Magnetic interference certification. Persons not familiar with these should review and digest the FDA guidance and reference documents; listed below.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077210.htm

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm106367.htm

RFI and EMI revalidation is considered essential when equipment is relocated. Radio frequency emitters and power cables can have a devastating effect on low power data processer hardware.


Combination IQ/OQ/PQ Protocol.

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
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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

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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.


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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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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.
Purchase your copy now at Special Price of $ 22.00.

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Some of Our Current Fast Moving Documents.


Combined IQ/OQ/PQ Equipment Protocol (Issue-2). -- $159.00
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Combined IQ-OQ-PQ Computer Protocol (Issue 3) -- $159.00
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Software Validation SOP (Issue-2) -- $22.00

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Software Validation Master Plan (issue-2) -- $115.00
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Software Validation Risk Assessment (Issue 2) -- $125.00
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Software User Requirements Specification. (Issue 2) -- $115.00
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Software Validation Plan (Issue 2) -- $89.00
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Software Design Qualification. (Issue 2) -- $89.00
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Software Installation Qualification. (Issue 2) -- $89.00

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Software Operational Qualification. (Issue 2) -- $89.00
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Software Performance Qualification. (Issue 2) -- $89.00
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Software Validation Package (Issue 1) -- $699.00
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GO TO:- VALIDATION ONLINE DOCUMENT STORE