Which Adverse Events need to be documented in a Validated Database?

Ryan Seaverson
Quality Assurance & Regulatory Manager

Many of our clients at SafetyCall market products that are regulated by the FDA, which makes the companies subject to numerous record keeping requirements, including the documentation of adverse events. The FDA defines the term “adverse event” as any health-related event associated with the use of a FDA regulated product that is adverse. If your company is inspected, the FDA may require access to detailed records ranging from manufacturing procedures and protocol, to consumer adverse event records.

In 1997, the FDA, in an attempt to preserve the integrity and validity of information, established industry requirements to govern the use of electronic records and electronic signatures. Called 21CFR Part 11, this set of regulatory requirements specifies conditions companies must meet with regard to electronic records and electronic signatures required under predicate rules. This means anytime there is a regulatory requirement to maintain a record, including adverse event records, Part 11 requirements must be met.

The scope of Part 11 is broad, given the variety of predicate record keeping requirements. Manufacturers of

  • prescription and OTC drugs
  • medical devices
  • dietary supplements

are all subject to mandatory requirements to maintain records of adverse events reported by consumers, and as such, are subject to the computer system validation requirements of Part 11.

If an FDA inspection were to include the review of electronic adverse event records, validation documentation may be requested by the inspectors. These validation deliverables may include, but are not limited to,

  • a formal validation plan
  • system specifications
  • installation qualification
  • operational/performance qualification
  • requirements traceability
  • user training
  • change control procedures
  • data protection procedures.

Simply put, all of these steps are time consuming and very expensive to perform in-house.

That’s where SafetyCall comes in. Utilizing specialized software developed specifically for the life sciences industry, we ensure all aspects of adverse event record keeping for our clients are in compliance with 21CFR Part 11 requirements. As part of the process, our healthcare specialists work closely with you to obtain all required case and company information. We ensure mandatory reporting requirements are met and that all adverse event database validation deliverables are available in the event of an FDA inspection.

Learn more about SafetyCall’s FDA adverse event management services.


Ryan is the Quality Assurance & Regulatory Manager at SafetyCall. He has been with the company for over 11 years. Ryan has his Masters of Biological Science from the University of Minnesota along with his Regulatory Affairs Certification (RAC) – Regulatory Affairs Professionals Society. His contributions to the organization are many; however, one of Ryan’s favorite parts of his job is helping our clients to understand their regulatory requirements as they pertain to post-market adverse event surveillance, computer system validation, and regulatory reporting.

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