Computer System Validation (CSV).

Computer System Validation (CSV) is at times by far the most onerous validation task that occurs in the industry. It can be almost impossible to split such systems into computer and equipment; therefore the system must be validated, taking note of the specifics of each and the overall functionality achieved by the system. While recognizing that the diversity of software, as defined in GAMP 4 & 5, is vast, you have to remember that the classic operating systems (same as, or similar to XP), because of the vast number in service, are taken as standard, and do not require to be validated. Therefore when you come to application software programs, that run on these standard operating system programs, your computerized system validation effort does not have to include the standard operation program, just the application program. For example, the application program for most Programmable Logic Computer (PLC's) is used to give equipment functionality, making validation quite a straight forward and simple task. However all software has to be managed and the, continued Good Manufacturing Procedure (cGMP) requirements for this operation system software, must be verified and documented, and this applies to all systems used in a cGMP enviroment.

The guide-lines laid out in Good Automated Manufacturing Practices (GAMP 4 & now 5) for the validation of computerized 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. Good Automatic Manufacturing Procedures (GAMP's) most recent release (No. 5) does not really over turn the previous release (No. 4). Allthough GAMP is definately a handy guide, it does try to be all things to all people. Which at times means certain sections can appear to contradict others.

On a recent project when a group was set up to develope a risk assessment 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 is a guide from the end users point of view. The actual legal requirements come from the regulators, and obviously takes precidence.

Validation Online's computer validation protocols include verification of elegibility and if so required, conformance with 21 CFR Part 11 issues, along with other cGMP issues regarding the handling, storing, backup and verification of software programs used in Computer Systems.

For most of the smaller systems (especially laboratory equipment) a combined Installation Qualification - IQ / Operational Qualification - OQ has been developed. This document combines the requirements of both the Installation Qualification and Operational Qualification, with a view to reducing documentation manpower time in raising, pre-approving and reviewing of completed documents. It would not be appropriate to use this combined document for major system validation, where the computer specific suite of interactive protocols such as Design Qualification - DQ - , Installation Qualification - IQ - , Operational Qualification - OQ - , Performance Qualification -PQ - , are the correct documents to use along with the standard Validation Master Plan - VMP - , User Requirements Specification - URS - , Validation Risk Assessment - VRA - , and Validation Plan - VP - documents.

EU BUSINESS CONTINUITY PLAN.

The EU GMP Annex 11 on Computer System Validation requires that there should be "adequate alternative arrangements for systems that need to be operated in the event of a breakdown". These arrangements should provide for alternative workaround procedures to be implemented and followed, to replace the absent system functionality and allow safe continuation of business during the failure.

CLICK HERE & GO STRAIGHT TO COMPUTER VALIDATION DOCUMENTS NUMBERS 10000590 - 760 TO VIEW OR BUY.

Regulators, and internal / external auditors, require evidence that Business Continuity Plans have been created and rehearsed, including records that the alternative processes have been suitably documented and personnel adequately trained. Companies should be able to demonstrate that they can ensure that critical services and processes can continue, that the restoration of workforce, facilities and equipment occurs in a timely fashion and that there is a timely resumption of essential business functions.

Good computer system validation starts with our quality three level fully detailed ��........User Requirements Specification (URS)��Then continues with our uniquely simple interactive ��........Installation Qualification (IQ)��..Followed by our similar interactive ��........Operational Qualification (OQ)��.and finishes with our interactive ��........Performance Qualification (PQ)��........Which you can purchase individually)��........ BY CLICKING HERE or as a package .��........ BY CLICKING HERE.

COMPUTER SYSTEM VALIDATION SCOPE (CSV).

The Computer System Validation (CSV), must include the under listed tests / inspections, but is not limited to them alone. The inclusion of the 21 CFR Part 11, Applicability is deliberate. This allows the executer of the protocol to clear this requirement by cross referencing the risk assessment reference number and stating Yes or No, to the applicability question. The regulator now does not have to search further, he can see that requirements for 21 CFR Part 11 have been considered and judged.

Introduction.
Scope.
Software Verification.
Hardware Verification.
Testing Personnel CV & Details Sheet.
21 CFR Part 11 Applicability.
Backup Software Storage Security.
Menu Navigation.
Operating Environment.
System Security (physical/access to data).
Power Failure Recovery.
Test Alarms.
System Stress Testing / Boundary Test.
Interface Signals.
Menu Navigation.
21 CFR Part 11 Conformance.
Functionality tests.

CSV STANDARD & FULL LIFE CYCLE REQUIREMENTS.

In the diagram below it can readily be seen that the computerized system validation activities are grouped in two colours (orange and blue). The use of software in a manner that can affect the quality of the product, without leaving visible evidence, that the product is damaged, must be deemed as critical to product quality.
The regulators have mandated that all such software be � identified as such - and subjected from concept, to Full Life Cycle Validation (FLCV) requirements. The vendor therefore (be they in, or out, of house), must produce a Quality Plan that replicates the testing and documentation presented in the diagram in orange. This diagram is for reference purposes only in this Computer System Validation (CSV), document. Your actual diagram must be justified for the software system that you are proposing.
It is of paramount importance that this QP is reviewed and approved by QA and the client or clients representative, prior to initiation of the design process. Remember the regulators want to see these documents in place, and it is practically impossible, to raise this documentation retrospectively.