Quality System Regulation.


The QS regulation requires that planned and periodic audits of the quality system shall be performed to verify compliance with the quality system requirements. The audits are to be performed in accordance with written procedures by appropriately trained individuals who do not have direct responsibility for the matters being audited. Audit results shall be documented in written audit reports, which shall be reviewed by management personnel, who have responsibility for the matters audited, and by other involved parties. Follow-up corrective action, including documented re-audit of deficient matters, shall be taken when indicated. Upon request of a designated FDA employee, an employee in management with executive responsibility shall certify in writing that the audits have been performed and documented, the dates on which they were performed, all or any required corrective action has been completed satisfactorily and the company QS system is compliant with the regulatory requirements.

When an auditor discovers any none compliance concerns; they are duty bound to dig deeper and deeper to enable them to accurately define the extent of these none compliances.


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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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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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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Combined IQ / OQ Protocol.
New from Validation Online a Combined almost ready to use; IQ-OQ protocol. Designed to cover equipment in general and specifically laboratory type equipment, with or without embedded or programmable software. This is not a list of chapter headings. It is a fully detailed interactive IQ and OQ protocol.


Combined_IQ-OQ_Issue-1 -- $125.00
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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 $22.00.
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Free Validation Document Downloads


Click Here for further details of CAPA AUDIT document.


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