GAMP
Good Automated Manufacturing Practice (GAMP) is a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.
One of the core principles of GAMP is that quality cannot be tested into the computerized system, but must be built into the computerized system during each stage of its development.
As a result, one of the key features of GAMP is computer system validation.
Computer System Validation
Computer System Validation (CSV) establishes documented evidence providing a high degree of assurance that a specific computerized process or operation will consistently produce a quality result, matching its predetermined specifications.
V-Model
In GAMP the V-model demonstrates the relationships between each phase of the development lifecycle and its associated phase of testing.
The left axis represents the stages of a specification and the right represents the stages of verification or testing.
Steps in the V-model are sequential, following the arrows, and every next step should only be started when the previous one is completed.
During software validation, the deliverables of each step are checked.
SCRUM
Scrum is the AGILE development framework in which cross-functional teams develop products or projects in an iterative, incremental manner.
It structures development in cycles of work called sprints.
Sprints
Sprints are iterations of no more than four weeks each, and take place one after another without pause.
At the end of the sprint, the team reviews the sprint’s results together with the stakeholders and demonstrates what has been built.
In the case of software, this would mean a system that’s integrated, fully tested, end-user documented, and potentially shippable.
INTEGRATION
On first sight, combining Scrum and GAMP doesn’t seem possible, because Scrum is an incremental process, and validation according to GAMP is sequential.
However, when confronted with this problem, you can decide to treat each Scrum sprint as a separate “GAMP V-model”.
This way, you can perform validation while the software is being developed and this is in line with both ways of working.
Software development is not an isolated activity.
To become a product, the result of the development must include documentation, ommunication, and, validation … amongst many potential additional activities.
In an agile environment, validation must be an integral part of the development process, with validation activities performed in each sprint.
One way to achieve this is by using automated testing tools that can validate functionality quickly and reliably.
Automated testing tools can be integrated into the development cycle, allowing testing to be performed automatically after each code change.
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