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We have had a large number of queries regarding the use of the Design Qualification, and we have been amazed at the number of these queries that try to justify not using a DQ at all.

The Design Qualification (DS) is executed as the final verification that the Design Specification (DS) if followed, will deliver the requirements that the end user has detailed in the User Requirement Specifications (URS), and that the design is compliant with all applicable regulatory, company, health and safety requirements. 

If you visualise the standard V validation chart where you descend the left leg of the V with the URS – FS – DS – (bottom of V) and ascend the right leg of the V, with IQ – OQ – PQ.  Then your DQ fits in at the bottom of the V.

With new build equipment it must be authored and executed prior to build authority being given.  With new build of facilities, it is extremely important since its execution verifies that the facility as proposed in the DS does what the end user wants, legally, safely and securely. 

With ‘Off the Shelf’ equipment or software, it must be used to verify that the proposed purchase can fulfil all the end user requirements as detailed in the URS.   

It cannot be over-emphasizes just how important the DQ is.  There are many horrendous blunders perpetuated by some really clever dedicated individuals, which would have been caught at DQ level, if there had been one.

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.
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

Calibration of Humidity & Hygrometer Sensors.

Humidity sensors require frequent calibration to ensure they are not causing your Air Handling Units to over dry the air for your facility. This is a very common fault and can increase your energy costs by over 200%. It really is cost effective to calibrate in house.

The calibration kit arrives ready to use and only requires annual recertification. It is housed in a robust neat and easy to handle carrying case.

To read more or purchase your test kit please click on link below.


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.

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.