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Computer system validation template or (qualification, as it is often erroneously termed) documentation must be compliant with all of the validation 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 for computer validator or  end-user  to follow . 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 system validation (CSV). Once this traceability is established 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 of  Computer system validation template  validation of 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 computer system validation method will produce results directly applicable to the device being tested;
• SCADA stands for Supervisory Control and Data Acquisition . As the name suggests, this system is used to monitor, collect data from and automatically control the production process. 
  
• The Human Machine Interface ( HMI) is the interface between the processor machine and the operator. In essence, it's an operator's dashboard.
  

• Insure that QC test devices are compatible with each other;

• Verify computer system validation programs used and to document the testing of the program.

• Certify all calibratables are included in a routine calibration program.

There must be correlation between the elements of the various phase deliverables / computer system validation template 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 computer system validation 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 computer system qualification 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.

Testing during computer system validation template execution verifies the execution flow of software, including pr ecision 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.

Testing during computer system validation template execution verifies the execution flow of software, including pr ecision 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.

St atic Analysis.

Code inspections  and testing can reduce coding errors; however, experience has shown that during computer system validation template process these should 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 andactual 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 computer validation 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 computer validation template 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 re validate the process.     

Re validation Justification .

Part 820.75  of the  QS  regulation requires that computer validation 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 system validation template documentation procedures in place for evaluating; when computer system validation is again required.  

Procurement and Computer 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 computer system validation 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.   

The Computer system validation template 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 system validation template unless a definitive predetermined and documented software User Requirements Specification in place, to validate against. Typical software requirements specify the following:

a) All equipment inputs;

b)       All computer 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.

Automated processes: When computers or automated computerized data processing equipment are 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 validation sometimes termed Regulatory Qualification, using purpose designed computer system validation template documentation. The execution of which will verify that all the pertinent URS and cGMP requirements have been complied with.

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

Once this documentation is produced, a complete package of computer 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 system validation template documentation activities are grouped in two colors (orange and blue). The blue color is the requirement for standard computer system validation template 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 subject from concept to actual use, to Full Life Cycle Validation (FLCV) requirements. This additional computer 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 computer system 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.