Documentation Administration are responsible for ensuring that good documentation practice and procedures are incorporated into any validation task. The task leaders must ensure that it is specified and built into the early procurement documentation. To wait until equipment has arrived and then ask the vendor for documents is usually an exercise in futility.
Very often certain documents are not actually produced, the drawings, the specifications, and the information in general, were all present during construction and testing, but often they are not retained or kept current during the construction phase. To expect to be able to request these retrospectively is plain wishful thinking.
If a complex system is deemed critical to product quality, then the documentation is used to verify the quality (tests, Inspections, reviews, certification) of the design, and build, is to the required standard. This detail of documentation is normally not produced or retained, unless the procurer has made the supply of it a condition of sale.
Whenever a new installation or changes or modifications are to be made to equipment used within a 21 CFR Part 210/211/820 compliant manufacturing, testing and or storage facility; a Validation Plan (VP) must be initiated in order to document and authorize all the attendant responsibilities, scopes and associated requirements. This VP will also define whether the proposed change will use a single User Requirements SpecificationA1 (URS) document for the change, or individual URS documents for all associated equipment allied to this proposed change.
The URS is of such an importance in FDA documentation administration practice that you can always be certain that time spent ensuring it is put together correctly, will pay dividends later in the validation process. Initially the document will contain the high level requirements of the end user; laid out in a clear and unambiguous manner. In the URS each of these requirements must be detailed in a manner that will render them verifiable by the execution of a testing or inspection procedure. This high level document is titled URS-Level-1. The requirements in this Level 1 document must subsequently be broken down into activities. Then these activities must be further broken down into direct tasks and support tasks. This is an engineering responsibility and produces URS-Level-2. If the system uses software, the tasks detailed in URS-Level-2, must be translated into lines of code by the software writer, these lines of code must be attributed and constitute URS-Level-3.
These URS Level 2 and 3 documents were once part of the Functional SpecificationA7 (FS), however the mandated requirement for traceabilityA7 from each requirement in the URS to the actual verification of compliance inspections or tests in the Performance QualificationA2 (PQ), forced a step change to be initiated to enable compliance with the Full Life Cycle Requirements in validation. Prior to this change; detailed traceability between the URS and the Design Specification (DS) had become difficult if not impossible to achieve. The use of levels of URS now reinstates the required traceability and engenders good testing between design and protocol verifications. During these activities the URS must be maintained as an active document with each (of the 2 or 3) stages being reviewed and approved on completion.
With the URS completed and approved, the procurement process can commence. When the successful design (or product, if off the shelf item is chosen) is known, its design must be subjected to the execution of a Design QualificationA3 (DQ) which will be used to verify that this proposed procurement will satisfy all the documented requirements in the URS.
The completion of the DQ allows the procurement process to complete and the ’hands on’ stage of the validation process to commence. Next we must execute a Validation Risk Assessment (VRA). This is often the most abused and misunderstood document in FDA documentation administration practice. The VRA is in place because the regulators have decreed that we must produce, and hold for regulatory inspection, a documented justification for the scope of validation activities we have deemed to be appropriate. They expect this justification to take the form of a risk assessment. This makes the VRA a very meaningful document. Your VRA must consider all the regulatory requirements and define a level of validation intensity that is cost effective to the end user, while being appropriate to the sophistication of the equipment and acceptable to the regulatory authorities.
Since the execution of the VRA will define the scope of validation; its execution, will allow the protocol authors to commence authoring the Installation QualificationA3 (IQ), the Operational QualificationA5 (OQ) and the Performance Qualification (PQ).
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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.
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.
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.
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