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 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.
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This Validation, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. Resulting in the document becoming notably easier to use and quicker to review and amend. This new format will make a very significant difference to the man hours required to produce and execute these documents. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document. This is an essential step forward for companies seeking to reduce validation costs without sacrificing regulatory compliance.
4Q Equipment Validation Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining validation documentation by reducing protocol numbers by close to 75%. The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new VrrP Protocol. By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks. For everyone's convenience, it is still written in word.
This quite revolutionary two document package is all that is required to fully validate; to cGMP standards, equipment used in a regulated facility. A lot of effort has gone into ensuring that repetitive instructions and actions have been designed out and innovative and intuitive risk-based methodologies have been incorporated. Both documents are prefaced with a methods Standard Operating Practice (SOP) document. These SOP’s lead you through the task of converting these highly detailed templates into your very own company bespoke protocols. The hyperlinks and cross-references within the package are; not only unique, but also highly cost effective and intuitive to use. Each document is preloaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are written in MS word, to facilitate simple editing of text, layout, tables and schematics.