21 CFR Part 11 Compliance – How to Ensure You’re Covered

To properly operate any regulated organization, thousands upon thousands of records are required. For decades, these records were printed and filed – offering physical evidence of the work being done to support compliance with good industry practice.

With the invention of computers and digital technology, however, the flaws of a paper filing system quickly became apparent. As digital records became more popular, the U.S. government grew concerned about the validity of the records used to audit and regulate companies. In 1997, to mitigate concerns over falsifying and changing records, the U.S. Food and Drug administration passed 21 CFR Part 11 Compliance.

What Is It?

21 CFR Part 11 Compliance is a piece of legislation that allows organizations to use and submit electronic records for record-keeping and auditing purposes. As a condition of that acceptance, the FDA also created 21 CFR Part 11 Compliance requirements to ensure the validity of these records through electronic signatures and validated electronic systems (esystems). To stay fully FDA-compliant, organizations must:

  • Be able to readily produce complete and accurate copies of their digital records
  • Use a validated system that protects, limits access to, and ensures the integrity of their records
  • Check their devices, systems, authorizations, and policies to ensure their records are protected and accurate
  • Validate the authority and electronic signatures of any users who have access to their records

How Has It Changed?

Though it’s been more than 20 years since 21 CFR Part 11 Compliance was passed, the legislation has remained unchanged since its creation. In 2003, the FDA created a guide to address changes in technology and help organizations understand the requirements. Despite the rapid advancements we’ve seen over the past 15 years, this guide was left unchanged until last year, when the FDA proposed a new draft guidance for 21 CFR Part 11 Compliance. Though there have been no further updates, the FDA has said this guidance will offer “recommendations for applying and implementing Part 11 requirement in the current environment of e-systems used in clinical investigations.”

What Does It Mean For Me?

As an asset owner, you are responsible for maintaining a system of records that meets the 21 CFR Part 11 Compliance requirements. While you can manage the authorization given to those in your organization, you rely on your system to protect and maintain the records you keep. If your system can’t reliably monitor your records and produce them when needed, your organization risks failing your next 21 CFR Part 11 Compliance audit and losing valuable time and money.

How Qualer Helps

At Qualer, we offer a system that is fully 21 CFR Part 11 Compliance validated. We understand the importance of meeting these requirements, so we carefully monitor our validation to make sure we meet all standards. By intentionally and reliably securing our system, we relieve your responsibility, giving you peace of mind about your records’ protection.

With our collaborative ecosystem, we also simplify the record-keeping process, helping you keep track of your information, important documents and 21 CFR Part 11 Compliance . By using Qualer to manage your assets, you can rest in the knowledge that your records are compliant and your organization is prepared for any audit.

Software: Lab Management SoftwareCalibration Management SoftwareMaintenance Management Software

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