Regulatory Responsibilities in the Cloud

Core to the process of ensuring quality in products is the concept of validation. This is the process whereby manufacturers provide objective, documented evidence that their processes, equipment and computerized systems are checked and validated to ensure the quality of their offerings.

Central to the validation journey is the required documentation produced with each step. To satisfy regulators, companies must record evidence to prove what work was done and when, including elements such as designs, tests and test-script executions.

A new method for achieving this is gaining significant traction. Known as the Cloud model, it sees companies handing off various parts of the validation process to third-party (or Cloud) providers who, for a fee, handle them on their own information technology infrastructure.

Companies that move to the validation of their Quality Management System (QMS) to the Cloud are still responsible for meeting the same regulatory obligations as in traditional models. They must:

  • Comply with regulatory requirements, including: validating and maintaining the validated state of their QMS; maintaining documented quality procedures; and auditing quality suppliers, including their software providers and cloud provider.
  • Maintain data integrity and data security
  • Control changes
  • Back up, recover and restore data

For their part in the regulatory picture, Cloud providers are responsible for keeping QMS records. Specifically, this involves:

  • Keeping accurate and complete copies of records
  • Protecting records
  • Limiting system access
  • Carrying out operational system checks, authority checks (who has what permissions?) and device checks
  • Maintaining a policy for accountability
  • System documentation
  • Ensuring the integrity of electronic records
  • Maintaining controls around electronic signatures
  • Password controls

Larger Cloud providers like Amazon and Microsoft have been working with life sciences companies for years. They have created platforms tailored to address the regulatory responsibilities particular to this industry.

To learn more about how companies are turning to the Cloud model to validate their QMS, download our free Definitive Guide on the subject today.

 

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