GAMP5 2nd Edition and CSA (Computer Software Assurance)

GAMP – Good Automated Manufacturing Practices was founded in 1991 and is a trademark of the International Society for Pharmaceutical Engineering (ISPE). It was designed to enable goods manufacturers meet FDA (Food and Drug Administration) expectations.

Good Automated Manufacturing Practices

GAMP5 was launched in 2008 and includes a set of procedures that help to ensure automation equipment/software meets required quality standards. In July 2022, the GAMP organisation released GAMP5 2nd edition, a revised version of GAMP5, which includes some significant updates that reflect the shifts that have taken place in software development since the publication of the first version in 1991.

Changes to CSA (Computer Software Assurance)

GAMP 5 has clarified CSA (Computer Software Assurance) which is also now being called Lean Validation.  CSA does not mean that the validation performed in any way provides less in terms of coverage than the traditional CSV method of validation. However, we are now testing smarter and more efficiently, spending 80% of our time testing and 20% of the time (anecdotal estimates of time) on documentation, which was the opposite way for CSV.

A Risk-Based Approach to Compliance

Below we have listed some of the many benefits of using a risk-based approach to compliance:

  • Involving both software developers and customers in the Risk assessments gives opportunity to each stakeholder to reflect on their goals and think about how things will impact the system.
  • Encourages stakeholders to think about which items will impact Patient Safety, product quality and data integrity.
  • Helps testers think about what needs to be considered for the script.
  • Allows testers to concentrate on the areas that have been classified as high risk that can impact Patient Safety, Product Quality or Data Integrity.

CSA and Cost Efficiency

The introduction of CSA enables issues to be found earlier in the process which reduces the costs of resolving bugs.  Ad hoc testing allows testers more freedom to do testing and to use critical thinking to explore the software. This has led to the uncovering of bugs sooner and has ensured a higher quality software delivered to the customer.

Why Your Validation Engineers Need to Keep Up to Date with GAMP Guidelines.

As GAMP is a guideline and not an industry regulation it is important to ensure that your validation engineers are up to date with the latest revisions and working to the highest industry standards available.

The Dataworks team of validation engineer’s work with GAMP 5 guidelines. They have extensive experience operating in the life sciences sector validating software systems and automation to FDA Standards – you can be assured that your software and equipment will be validated to the highest industry standards by our skilled engineers.

Our team of experienced engineers can help you to enable greater efficiencies, improved quality and compliancy within your industry.

If you would like to discuss how we can help you with your validation needs please call us today on 051 878555 or email us at

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