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Myth Busting FDA Validation

Arbour Group had the pleasure of joining Navigator, an SAP solutions provider, in the webinar, Busting the Myths of FDA Validation and Business Systems. Our VP of Sales, Archie O’Leary, discussed the process of validation for manufacturers and distributors in the Life Sciences.

They reviewed various requirements and expectations as well as challenges and myths associated with validation.

What is FDA validation?

The goal in FDA Validation is to ensure regulated manufactured products are produced according to a pre-approved standard to ensure safety and effectiveness.  In the event of a recall, electronic records related to product characteristics and manufacturing processes need to be accurate and reliable. The responsibility of the Food and Drug Administration (FDA) is to ensure the welfare of the public through the validation requirement.

What is 21 CFR Part 11?

21 CFR Part 11 compliance addresses electronic records and signatures and their associated requirements. Therefore, computer systems that generate, revise, and maintain electronic signatures and records are subject to validation. The FDA needs assurance that a computer system’s hardware and software controls meet predetermined standards and processes, and the resulting quality records are safeguarded.

What is Software Validation?

Software validation demonstrates that a life science company has a well-documented software system with evidence that regulated functionality has been tested for its intended uses. It includes the manufacturing process for the actual product, the materials that were used to create it, and any traceability to include shipment destinations.

What Validation Deliverables are needed?

There are industry and best practice standard deliverables. However, these deliverables should be developed in the context of a quality system that specifies a software development life cycle (SDLC). Validation documentation should include a validation plan, functional requirements specifications, test protocols associated with the functional requirements, i.e., (Installation - IQ, Operational – OQ and System -PQ), a requirements trace matrix, and a validation summary report.  The validation summary report includes a recap of test results to demonstrate the resolution of test failures.  The validation summary report notes how the system will be maintained in a validated state per a specific change control Standard Operating Procedure (SOP).

Validation Myth: Validation is not required for applications in the cloud.

Validation is testing the intended uses, regardless of the location of the platform on which the software executes. Cloud software developers must ensure their systems are not only working correctly per published procedural controls but also must ensure end-user customers can validate their systems. Arbour Group can assist with the development of cloud compliance documented evidence to meet regulatory requirements. 

Validation Myth: Cloud providers are not responsible for complying with customer compliance.

The manufacturer is responsible for a compliant system, and to that end, must make sure the cloud provider has set standards to protect their data integrity in terms of handling maintenance updates, backup and recovery, security controls, and any disaster recovery. An audit can help ensure a cloud provider complies with a regulated quality system. Cloud providers in the Life Sciences should also have quality agreements detailing how they provide maintenance, execute updates, implement releases, and the period of time available to a user before accepting a release.

Validation Myth: Every software release update requires validation.

A user needs to have change control procedures in place that evaluates software releases to ensure adequate testing occurs. Releases that have no regulatory or Good Manufacturing Practice (GMP) impact do not require additional validation testing. However, if a release update affects a regulated process such as inventory control, an impact analysis identifies the testing that requires a response.

Validation Myth: Validation is not required for Excel spreadsheets.

Excel spreadsheets must be validated if they hold quality data of test records such as lab test records or manufacturing/statistical process calculations.  Spreadsheets must be protected via password control, and a procedure for the spreadsheet must be in place.

For the detailed conversation on the myths and challenges of FDA Validation, check out the full webinar on Navigator, where compliance experts answer additional validation questions.


Talk to an Arbour Group representative today if you have any further questions on validation.