Computer Equipment Validation Rationale.

This graphic of a writers pen, as used in authoring  computer equipment validation templates.

Computer Equipment Validation or Qualification, as it is often erroneously termed, documentation must be compliant with all of the current Good Manufacturing Practice legislation and follow all the associated guideline documents.
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 detailed user requirements remain attributable throughout the development of the Functional Specification (FS) Design Specification (DS) to the actual lines or groups of lines of code that enable them.

Traceabilty of URS functionality, to lines of code is an essential element in computer equipment validation (CSV). Once this traceability is establish future maintenance and modification of software is made much simpler and more manageable.

There is much discussion throughout the industry regarding the use of automatic testing programs. A recent guidance document contained these details of current thinking among the regulators. Proposals for device manufacturers would require manufacturers that use automated quality control measurement (this could include almost any automation equipment used within a medical device or in the production of a controlled product) equipment to

  • Determine the validity of the automated test and determine whether the method will produce results directly applicable to the device being tested;
  • Insure that QC test devices are compatible with each other;
  • Verify computer programs used and to document the testing of the program, and
  • Have a routine calibration program with appropriate records

Traceability in Computer Equipment Validation.

There must be correlation between the elements of the various phase deliverables / computer equipment validation documentation; for example, the correlation between the functional requirements and the test cases that challenge them. This correlation can be demonstrated by using a traceability matrix. This matrix facilitates maintenance of the cross-referencing between requirements, the corresponding design elements, and the test cases that challenge them, as well as between the design and the code.

During the design phase, the traceability matrix can help facilitate design review since correlation of requirements to design can unearth mismatches and omissions.  Additionally, completing the traceability matrix can help ensure adequate test coverage in the testing phase.  In the equipment’s maintenance phase, if any of the requirements or design elements need to be updated due to a change, it is easy to determine what other documents are affected and/or what tests must be re-executed once the change takes place. In short, the usefulness of the traceability matrix cannot be overstated.

Validation Tests and Interpretations.

Dynamic Testing

This type of testing verifies the execution flow of software, including decision paths, inputs, and outputs. Dynamic testing involves creating test cases, test vectors and oracles, and executing the software against these tests. The results are then compared with expected or known correct behavior of the software.  Because the number of execution paths and conditions increases exponentially with the number of lines of code, testing for all possible execution traces and conditions for the software is impossible.

Static Analysis.  

Code inspections and testing can reduce coding errors; however, experience has shown that the process needs to be complemented with other methods . One such method is static analysis. This somewhat new method largely automates the software verification process.  The technique attempts to identify errors in the code, but does not necessarily prove their absence.  Static analysis is used to identify potential and actual defects in source code.

Abstract Interpretation Verification.

A code verification solution that includes abstract interpretation can be instrumental in assuring software safety and a good quality process. It is a sound verification process that enables the achievement of high integrity in embedded devices. Regulatory bodies such as the pharmaceutical regulators.

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 analysing 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 re validate the process.

Re validation 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   review and evaluate the process and perform re validation when appropriate.  21 CFR 820.75(c) requires you to have computer equipment validation documentation procedures in place for evaluating; when computer equipment validation is again required.

Procurement and Computer Equipment Validation .

Recent research has highlighted that in the pharmaceutical and bio-medical industry, thirty two per-cent of all equipment procurement is 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.

VMP to VP Correlation and Integration.

This graphic display illustrates the interrelationships  between the various computer validation templates.


Computer Equipment Validation URS.

The Software User Requirements Specification (SURS) document should contain a written definition of the software functions. This must define the functionality that the end user requires from the equipment.  These "requirements" must be set out in a manner that is none ambiguous, clear and easy to understand. Further to this the requirements must be grouped or worded in a manner that renders them testable and verifiable. It is not possible to design satisfactory computer equipment validation documentation  unless a without having a definitive predetermined and documented software User Requirements Specification in place, to validate against. Typical software requirements specify the following:

a)         All software equipment inputs;

b)         All software equipment outputs;

c)         All functions that the software equipment will perform;

d)        All performance requirements that the software has to deliver.

e)         The definition of all external and user interfaces.

f)          How users will interact with the equipment;

g)         What constitutes an error and how errors should be handled.

h)         Required response times;

i)           The intended operating environment for the software.  

j)           Ranges, limits, defaults & specific values found acceptable.

k)         All safety related requirements, specifications.

l)           The degree to which the manufacture is dependent upon that software.

Computer equipment Validation Change Implementation.

Picture of a computer validation templates controlled welding machine.

Automated processes:  When computers or automated computerized data processing equipment is used in any way which can affect the quality, efficacy or regulatory records of a regulated product or process, the manufacturer must carry out computer equipment validation; sometimes termed Regulatory Qualification, using purpose designed computer equipment validation documentation.  The execution of which will verify that all the pertinent URS and cGMP requirements have been complied with.

Post completion of computer equipment validation; any future proposed software or hardware changes must be approved prior to implementation.  Post implementation it is required to execute a Validation Risk Assessment (VRA) to ascertain the degree of validation that is required; to return this equipment to the “qualified” status. 

Computerized Design & Testing

Graphic block display of computer validation templates.

In this diagram it can readily be seen that the URS, along with the VMP and the applicable company Practices and Procedure documents, come together and are used to produce a Project Quality Plan (PQP).  This can be vendor or end user produced.   This PQP must document the scope and intensity of the QA and QC involvement in the design, build, test, commissioning and validation of the proposed equipment.  The PQP will also specify the range of documentation that must be produced to enable the regulatory compliant introduction and maintenance of the equipment into cGMP use.

Critical Software defined.

Once this documentation is produced, a complete package of validation or Qualification documents will be raised consisting of the DQ, IQ, OQ and PQ.  The execution of these protocols must verify that all the end user's requirements as specified in the URS are fully complied with.  Computer equipment validation documentation activities are grouped in two colors (orange and blue).  The blue colour is the requirement for standard computer equipment validation documentation.

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 computer equipment validation documentation is represented in the diagram in orange.

The vendor therefore (be they in, or out, of house), must produce a Quality Plan that the software development will follow. A validation plan similar to that shown in the diagram. Your actual diagram must be planned and justified for the software equipment that you are proposing.


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Computer Combined IQ-OQ-PQ (Issue 3) -- $159.00

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. It is interactive, easy to use and suitable for all mixes of equipment with and without a software validation requirement.

Computer User Requirements Specification (Issue 5.) -- $115.00

The document that specifies software validation standards for 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 validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved.

Computer Validation Master Plan (Issue 5.) -- $115.00

The Computer equipment Validation Master Plan, is the starting point for software 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.

CSV Validation Plan (Issue 3.) -- $89.00

This document follows Validation Online's standard method of using a fully detailed and interactive generic document and enabling to use the attached SOP to quickly convert this generic document into a first class company bespoke document. This Computer Software Validation VP, details and integrates all software validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.

Package for Computer Validation Level-1. (Issue 1) -- $675.00

This computer equipment validation package is suitable for all major software validation projects and contains the underlisted interactive documents. VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.

Package Computer Validation Level-2. (Issue 3) -- $610.00

The complete chain of regulatory required documentation for the validation of a computer system minus the VMP. This sofware Validation Package contains one of each of these documents:VP, URS, DQ, VRA, IQ, OQ, PQ.

Computer Vendor Audit (Issue 3.) -- $105.00

This Computer Vendor Audit document should be customized using the built in tools. The document can then be targeted to reflect your project priorities. The fifteen chapters all contain 10 questions, the total scored is then weighted to reflect your priorities. By assessing the importance of each of the chapter subjects in your project, the weighting is altered taking points from one and adding to others. This enables your assessment to be expressed simple and clearly as a percentage, allowing clear unambiguous comparisons to be presented for competing companies.

CSV Design Qualification (Issue 3.) -- $89.00

The Standard Operating Procedure attached to this generic computer design qualification protocol, will chapter by chapter take you through the task of raising a fully detailed protocol. The main body is split into fourteen tables, each one probing the computer design requirements and standards for the individual requirement. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.

CSV Installation Qualification (Issue 6.) -- $115.00

Computer Installation Qualification (CIQ) is an important step in the overall software validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements.

Operational Qualification (Issue 6.) -- $115.00

Operational Qualification (OQ) is an important step in the overall software validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements, progressively and simply.

Computer Performance Qualification (Issue 7.)  $87.00

The Computer Performance Qualification is the culmination of the software validation process. The protocol is used in conjunction with the system operating SOP, to verify that the system process is consistent and correct. The results of the testing must be recorder and reviewed with a view to ensuring that any deviances (within permitted tolerances) that exist are random and not a trend that will lead to out of specification operation during production use.