How to write a superb computer Qualification Protocol

Understanding the intricacies of conforming with the "How to write a superb computer qualification protocol" will be explained further as you read through this text. The guide-lines laid out in Good Automated Manufacturing Practices  GAMP 5 , for the computer qualification template of automated systems including automatic computerized manufacturing equipment, control systems, automated laboratory systems, manufacturing execution systems and computers running laboratory or database systems. These computerized systems generally consist of the hardware, software and netware components, together with all control functions and GAMP 5 is a useful guide in scoping your validation online activities for such systems. It must be remembered at all times that GAMP is collective ideas from the computer qualification industry and does try to be all things to all people.

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Dynamic Testing.

Dynamic computer qualification template 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 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 repeat of all computer qualification template activities, 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 procurement's 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 unnecessary and costly retrospective actions in understanding how to write a superb Computer Qualification Protocol for the equipment or producing unspecified documentation or engineering drawings, post procurement. These extraneous GMP requirements often cost more than the original equipment.

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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 system. 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 for computer qualification template to be properly executed without having predetermined and documented software strong requirements to validate against. Typical software requirements specify the following:

a) All Computer Qualifications system inputs;

b) All Computer Qualifications System outputs;

c) All functions that the software system will perform;

d) All computer qualification template performance requirements that the software will meet.

e) The definition of all external and user interfaces.

f) Understanding how to write a superb Computer Qualification  Protocol.

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

h) Required response times;

i) The intended operating environment for the software.

j) All ranges, limits, defaults, and specific values.

k) All safety specifications & features.