COMPUTER VALIDATION (CSV).

Validation Online's GMP compliant computer validation (CSV) documentation and protocols start with our unique three level User Requirements Specification document (URS). Since most documents, post the URS, will either fully, or partially, base their contents on the URS, it is essential that this document clearly, concisely and in a manner that is testable, specifies the exact requirements of the end user. It is also essential that these exact testable requirements remain attributable through the development of the Functional Specification (FS) Design Specification (DS) to the actual lines or groups of lines of code that enable them.

SOP for Computer Equipment Validation.
The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.

The guide-lines laid out in Good Automated Manufacturing Practices GAMP, GAMP 5, for the computer validation of automated systems including automatic computerized manufacturing equipment, control systems, automated laboratory systems, manufacturing execution systems and computers running laboratory or database systems. The automatic computerized system generally consists of the hardware, software and network components, together with the controlled functions and associated documentation. The recent release of GAMP 5 Procedures   does not really over turn the previous release GAMP 4.  Allthough GAMP 5 is definitely a handy guide, it does try to be all things to all people.

Which at times means certain sections can appear to contradict others.<br>On a recent project when a group was set up to develop a Risk Assessment (RA) document from GAMP 4, after four weeks they were still divided and unable to reconcile the requirements.  It bodes well to always remember that GAMP 5 is a guide from the end users point of view.  The actual legal requirements come&nbsp;from the regulators, and obviously takes precedence. <br>Validation Online's computer validation (CSV) protocols start with the development of a detailed three layer URS and progress through the VMP - IQ - OQ - PQ.  Each of these documents are interactive and simple to use.  Each are preceded with an SOP which guides the user through all phases of protocol generation.
The verification that the end users requirements as detailed in the URS have been fully satisfied, is paramount to the equipment being correctly qualified.  Often this is hard to verify since the traceability from URS functionality to the actual hardware or software utilized is lost in the code generation stage.

However unless the effort is made to maintain this traceability, validation is flawed and future modifications can become problematic.

The Validation Master Plan -  VMP, must be specific about this requirement and instruct all personnel involved in the qualification program, of the importance of maintaining this traceability.

VIEW COMPUTERIZED SYSTEM VALIDATION DOCUMENTS AVAILABLE.

COMPUTER VALIDATION USER REQUIREMENTS.

1. All software system inputs;
2. All software system outputs;
3. All functions that the software system will perform;
4. All performance requirements that the software will meet, (e.g., data throughput, reliability, and timing);
5. The definition of all external and user interfaces, as well as any internal software-to-system interfaces;
6. How users will interact with the system;
7. What constitutes an error and how errors should be handled;
8. Required response times;
9. The intended operating environment for the software, if this is a design constraint (e.g., hardware platform, operating system);
10. All ranges, limits, defaults, and specific values that the software will accept;
11. All safety related requirements, specifications, features, or functions that will be implemented in software.
12. The degree to which the manufacturer is dependent upon that software or equipment for production of a their product.

CONTENTIOUS POINTS IN VALIDIZATION

REVALIDATION SCHEDULED

There is no regulatory requirement to re-validate a process as long as that process operates in a state of GMP control and no changes have been made to the process or output  product, the process does not have to be revalidated. Whether the process is operating in a state of control is determined by analyzing day-to-day process control data and any finished device testing data for conformance with specifications and for variability.

REVALIDATION on RELOCATION

When equipment is moved to a new location, installation and operation should be re-qualified. By comparing data from the original installation and operation qualification (IQ and OQ) and the re-qualification, the manufacturer can determine whether there have been any changes in equipment performance  as a result of the move. Changes in equipment  performance should be evaluated to determine whether it is necessary to revalidate the process.

 REVALIDATION JUSTIFICATION

Part 820.75 of the QS  regulation requires that validated processes be monitored and controlled so that when changes or process deviations occur, a manufacturer will know to review and evaluate the process and perform revalidation when appropriate.   21 CFR 820.75(c ) requires you to have documented procedures in place for evaluating; when revalidation is required.

PROCUREMENT and VALIDATION.

Recent research has highlighted that in the pharmaceutical and bio-medical industry, thirty two percent of all equipment procurements are unsatisfactory.  The major problem has been identified as companies not specifying in sufficient detail and or accuracy, what their actual needs are.  The lack of a quality company approved User Requirements Specification (URS), leads to many companies having to resort to otherwise un-necessary and costly retrospective actions in modifying the equipment or producing unspecified documentation or engineering drawings, post procurement.  These extraneous GMP requirements often cost more than the equipment.

GAMP 5 SOFTWARE CATEGORIES.

COMPUTER VALIDATION SCOPE (CSV).

Automated processes:  When computers or automated computerized data processing systems are used in any way which can affect the quality, efficacy or regulatory records of a regulated product or process, the manufacturer must carryout validation of the software and or computer system used. Post computer validation; proposed software and or computer changes must be approved prior to installation, and the validation status re-established post installation. These activities must be adequately documented.

COMPUTERIZED SYSTEM DESIGN & TESTING

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 computer validation (CSV) requirements as given in the VMP, come together to form a document package consisting of the DQ, IQ, OQ and PQ from which the vendor can develop a fully legal and compliant product.  Computer validation (CSV) activities are grouped in two colours (orange and blue).  The blue colour is the requirement for standard computer validation (CSV).

The 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 validation is represent 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 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 computer validation (CSV) process, you must expect the regulators to want to review them. 

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COMPUTER VALIDATION (CSV)