Equipment qualification or validation as required by the FDA, requires verification documentation to start with the Validation Master Plan (VMP) and flow through a series of documents that define the scope and tasks required to successfully execute your equipment qualification task. The VMP dictates the actions that all persons involved in equipment qualification projects must comply with. The Equipment Validation Plan (VP) may often be designed to include more than one piece of equipment. The list of equipment will be appended to the plan. Each of these items will have its own stream of documentation; typically,
The VMP is not mandated by the FDA, but is always asked for in regulatory reviews and inspections. (URS - DQ - VRA) are mandated and self explanatory.
With the Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (P1Q) and Process Qualification (P2Q), there is a degree of flexibility as regards to the content of these documents. Although the document title clearly defines it’s scope, it is possible and permissible to arrange some elements of testing in the most expedient sequence. I.e. do you wait for power 'on' to do IQ, perhaps? Perhaps not? It can be argued that when power is on you are operating the equipment (so power on testing should be in the OQ). Can IQ therefore be completed prior to power up?
It can, and often is, hotly
debated whether all the testing carried out in the FAT, SAT and commissioning stages, must be
repeated in the equipment qualification. (i.e. are you going to repeat some
of the testing four times?) This is where the VP becomes a vital document.
Senior persons with a good understanding of the overall project, can decide the content and scope of each of these documents, obviously within the framework of existing cGMP legislation and guidelines. They can actually develop a quite unique sequence of equipment qualification tasks for a number of reasons (to reduce repetitive testing - to ease access problems – to sequence with other activities, and on), providing that their rationale is documented in the VP and posts a plausible justification.
The VP is then used by the protocol writers as the official mandate for protocol content.
In the diagram below it can readily be
seen that the URS, along with the regulatory requirements as detailed in
GAMP 5, and the details of validation requirements as given in the VMP,
to form a package from which the vendor can develop a fully legal,
compliant and validateable product.
Equipment qualification templates are available for the activities shown grouped in the two colours (orange and blue). The blue color is the requirement for standard computer validation, while the orange color depicts the additional equipment qualification templates that are required when the process executed by the during equipment qualification has been identified as critical.
The FDA regulators have decreed that software used in a manner that can affect the quality of the product, without leaving visible evidence, that damaged has occurred, must be deemed as critical to the quality of that product.
The regulators have further mandated that all such software be identified as such - and subjected; from concept to actual use, to Full Life Cycle Validation (FLCV) requirements. This additional level of validation requires the addition of further validation GMP qualification templates as portrayed in the diagram in orange.
The vendor therefore (be they in, or out, of house), must produce a Quality Plan that ensures the software development will follow a validation evolution similar to that shown in the diagram. Your actual diagram must be planned and justified for the software system that you are proposing.
It is of paramount importance that your decision on software criticality is documented, and that your Quality Plan (QP) is reviewed and approved by QA, and the client or their representative, prior to initiation of the design process. Since these documents all form part of the equipment qualification process, you must expect regulatory inspectors to be interested in reviewing the content and the format of them.
required FDA Compliant documentation must be carefully prepared, with
statements worded to preclude ambiguous and incorrect interpretations of
of the statement. In addition there are quite separate requirements
stipulated by the regulatory authorities. Documents presented to
regulators during inspections that fail to satisfy these requirements,
indicate to the regulator a lack of care and commitment on the
part of the company. The exact opposite to what is required.
The FDA and regulatory authorities in general, are charged with increasing the level of compliance throughout the industry. This call for increased regulatory compliance, is driven by evidence that the industry is failing to match the standards set by other regulated industries.
Validation Online, have designed unique interactive documents for all validation activities such as VMP, URS, IQ, OQ, PQ, and many others. These documents have all been designed to be cGMP, compliant, along with incorporating the structures the regulators look for. These documents are realistically priced to ensure it is much more cost effective for companies to download documents as they require them, than individually author them.
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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 qualification. It is interactive, easy to use and suitable for all mixes of equipment with and without software.
The document that sets the standard, and specifies your computer requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful equipment qualification to be completed. This document was designed to be used as a live document up until the DQ is completed and approved.
The Computer equipment qualification and Validation Master Plan, is the starting point for validation, and hence the most important validation document. It improves validation efficiency greatly by forcing all concerned to document, review, and discuss, the proposed methods and allotted responsibilities. It is an expected document with the FDA, and a mandated document with the EU.
This computer equipment qualification and validation package is suitable for all major validation projects and contains the under-listed interactive documents. VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.
The complete chain of regulatory required documentation; for equipment qualification and validation of a computer system, minus the VMP. This Validation Package contains one of each of these documents: VP, URS, DQ, VRA, IQ, OQ, PQ.