FACILITY UTILITY HVAC QUALIFICATION.


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Facility Utility HVAC Qualification Introduction.

This HVAC Qualification document; along with the attached Standard Operating Procedure, will, chapter by chapter take you through the task of raising fully detailed HVAC protocols. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these aspects of document design allowing you to delete some you feel are not relevent to your equipment. It is a superbly easy document to use and will ensure that you’re Facility Utility HVAC qualification  protocol's are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.



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HVAC Installation Qualification.

This combined Facility Utility HVAC qualification, validation SOP and IQ template makes it so easy for you to raise a quality IQ. With the new suite of HVAC documents from the DQ - IQ - OQ - PQ, all user friendly and ready to go, your validation life has got much simpler. The final product is a professional and comprehensive Heating Ventilation and Air Conditioning Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past. There is now no reason for not being able to produce 4 to 8, IQ protocols per 8 hour day, or a complete suite in one day.


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HVAC Operational Qualification.

This easy to use Facility Utility HVAC Qualification SOP and Protocol, can be simply and quickly converted (using find replace techniques) into your own company bespoke document. Now you can purchase these document in a suite DQ to PQ, getting you ready at express speed to qualify a system. It has never been quicker or simpler.



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HVAC Performance Qualification.

This fully formatted Facility Utility HVAC Qualification is the last in the chain of qualifying tests that HVAC systems are subjected to, before being considered qualified. However environmental qualification is required to verify air quality.


HVAC QUALIFICATION.



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Validation Master Plan (Issue 8) -- $115.00

The Validation Master Plan (VMP) must present an overall picture of the company facility, organization and capability. It must give a clear and concise overview of how the company has integrated all applicable cGMP requirements as specified in 21 CFR Part 11, 210, 211 and 820 into its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving, and executing validation documentation and tasks.  It must mandate the production of all Practices and Procedure manuals and SOP's.

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Validation Plan (Issue 10) -- $93.00

The VP must document all methodologies, boundaries and responsibilities, along with defining validation limitation and scopes.  It is a master reference for all validation variables and queries.

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Validation Risk Assessment (Issue11.) -- $125.00

When you declare that your validation is Risk based; then it is incumbent on you to use a suitable tool to convert the perceived level of risk to an appropriate intensity of validation.  This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.  This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance rulings.

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 Package for Equipment Validation Level-2. (Issue 3) -- $585.00

During a regulatory visit the inspectors do expect to see a complete suite of validation documents in place for each validation task.  The use and scope of the individual documents has been documented, discussed and explained in detail.  It is therefore obviously best policy to have in place exactly what the regulator is looking for.  The use of a document packages ensures a multitude of regulatory requirements are catered for and possibly a similar multitude of pitfalls, blunders and omissions are anticipated and negated

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