Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
GDP – Computer System Validation
Computer Systems Validation
The term refers to the process and procedures carried out for the businesses which maintain the required level of compliance at all stages of the product development. The processes ensure that the system can consistently produce and deliver the expected results over long periods of time.
The term comes from the word “Valid” – which means something that adheres to a set of official guidelines or is legally acceptable.
Why do we perform Computer Systems Validation?
Validation is broadly a part of Quality Assurance which as the name suggests is performed to ensure that the process, product or service is that of a desired Quality and whether the system complies with the requirements, functions as intended and meets the business goals and customer needs.
The validation procedure may include various aspects such as integration, Performance, Processes and Systems.
We perform validation to ensure that the “right product is built”. It helps to determine the worst-case scenarios and the risks that may occur during the manufacturing of the product.
Most Importantly, validation is now a regulatory requirement of UK MHRA, US FDA, Schedule M and other regulatory agencies in the world which focus on validation of different systems and processes during their GXP audits.
How to perform Computer Systems Validation
Validation should be conducted on the finished product and executed under actual or simulated use conditions – does it do “what it says on the tin”?
The way you perform the procedure is dependent on whether you are validating a product, a process or a document.
For example, validating a product would include comparing the finished product with the set of initial requirements that are given at the point of manufacturing. This will then include further aspects of validating design, performance, functionality and integration. On the other hand, validating a process may include a step-by-step verification of regulatory guidelines that are meant for the process and determining the compliance of the same.
Validating a document will include tests that in essence qualifies the content of the document, e.g; an excel sheet containing Temperature requirements of a GDP licensed warehouse will have to be done differently than to an excel sheet containing employee attendance data.
For a Computer Software validation, the process is much more complex and will depend on the intricacy of the system, and it may sometimes even include validating all of the above individual aspects in order to ensure that the entire software is “built right”.
What happens if we don’t perform Computer Systems Validation?
The risk of regulatory non-compliance is greatly reduced because of validation. The procedure, if ignored or done very late in time, can incur huge costs to companies.
For the various industries that have adapted a lifecycle approach to a product or process development, this procedure can control critical process parameters and safeguard the products against sources of variation which may have been ignored during the process of manufacturing or development. It gives the users a chance to re-verify and support the implementations of changes or addition of new features before they hit the end user and cause any major disruptions.
.Do you need support with validation of your computerised systems? Call 0330 133 0920 for a no-obligation conversation or use the form at the foot of this page to contact us.
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