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Laboratory Validation Package Introduction.

Here is the ideal laboratory validation package for the busy laboratory manager or technician.  It contains a Validation Plan (VP) to set out scopes, responsibilities, time lines and methodologies, in a clear simple way that will not only please your regulators but will ensure your own compliance.   A Design Qualification (DQ) that will verify that the design of each individual piece of laboratory equipment is compliant with all appropriate GMP's and all requirements that are detailed in the associated URS.  A Validation Risk Assessment (VRA) to ensure your scope is set at the appropriate level validation for the equipment being qualified and the redoubtable fully detailed and interactive Combined Installation, Operational and Performance Qualification Protocol (IQ/OQ/PQ); specifically developed by Validation Online for laboratory equipment with or without embedded software.


Validation Package Use.

Validation Online’s combined IQ/OQ/PQ protocol was specifically designed to be used for laboratory type equipment.  This document contains three protocols which collectively have approximately thirty inspections or tests that must be executed to verify that the item under qualification is used, operates and performs in a manner that satisfies all the appropriate requirements as detailed in the relevant User Requirements Specification (URS), cGMP’s and your company practices and procedure rulings.

All companies carryout routine calendar based qualification and requalification functional testing of stand-alone laboratory type equipment.  Unfortunately most of this testing is documented in a manner that is not compatible with basic FDA validation protocol standards.  If a little time was spent on revamping these test documents standards, (changing the template would only have to be done once) a format could be used that would enable all such testing to be included in any validation requirement.

Since regulators already accept the concept that unnecessary retesting should be avoided whenever possible. It follows that since all other tests in our protocols are fully written up, if the routine functional testing was of the right format then a recently executed routine or commissioning test could be reviewed and commented on in any validation protocols,  as an alternative to repeating all the associated testing. This would result in the time line and cost of validation for this equipment being greatly reduced.

Click here to view the FDA requirements for protocol testing formats and wording.