Agile can work well, too, in highly regulated industries but does require some adjustment. The nature of agile flexibility and its iterative nature can easily align with regulatory requirements if compliance and documentation happen at the right stages.
Key Adjustments:
Incremental Compliance Checks: The regulatory requirements can be checked in smaller, manageable increments during each sprint to ensure compliance as the project progresses.
Documentation Flexibility: While Agile reduces the need for upfront documentation, the generation of essential regulatory documentation can still be iterated to support a team's natural flow of work and relevant compliance needs.
Cross-Functional Collaboration: Agile fosters collaboration, which is more relevant in regulated industries to ensure that legal, compliance, and quality teams are aware of the developments.
Frequent Audits: Recurring inspections or audits during sprints will ensure that the product is always compliant with regulatory requirements, meaning there will be no compliance nightmares at the last minute.
Example:
Agile can be applied to the development of pharmaceutical clinical trial software. Conformance checks and validation may be performed at the end of each sprint to comply with all regulatory compliance requirements but with flexibility for adaptation and improvement.
