Clinical Trial applications
and 21 CFR 11 compliance

The Life Science industry is highly regulated and the bar for compliance is very high. ShareVault data rooms are widely used for document security and sharing in clinical trials applications including the following:

  1. Managing clinical trial documents that make up an electronic Trial Master File (eTMF).
  2. Remote clinical trial site monitoring and reporting to comply with trial and site protocols.
  3. Enabling review of clinical trial documents by an Independent Review Board (IRB).
  4. Enabling data safety and monitoring committee (DSMC) reviews.

eTMF document management and remote clinical trial monitoring during multiyear trials requires protecting highly confidential documents and ensuring inspection readiness to respond in a timely manner to FDA audit requests. Clinical trial sponsors and CROs using ShareVault for these applications are responsible and must comply with 21 CFR 11.

The risk of non-compliance during an inspection, could result in an FDA Form 483 (a document that communicates concerns discovered during an inspection), a warning letter, an injunction (that may include a market recall on products), or a consent decree. These FDA actions can result in costly penalties — directly or indirectly.

Clinical Trials Sponsors and CROs using ShareVault are responsible and must comply with 21 CFR 11 or risk an FDA audit. ShareVault software includes the features and tools such as end to end document encryption, granular access controls and detailed activity reporting that enables 21 CFR 11 compliance by customers.

As a result, it reduces the regulatory burden as trials progress through more complex stages and enables ongoing inspection readiness for supporting an FDA request for audit at any time.

ShareVault 21 CFR 11 Validation

ShareVault supports the critical requirements for 21 CFR 11 compliance including: System Validation; Audit trails; Copies of and Searchable records/documents; Record retention Security controls; eSignatures (optional); System training

To this end, ShareVault now offers a 21 CFR 11 Validation Package to customers for each new software release. The validation package is available in a secure ShareVault portal and includes a Validation Summary Report which summarizes the completion of the overall software quality validation process for the ShareVault software release.

21 CFR 11 Consulting Services

ShareVault and expert partners will also work with customers to assist in customer internal compliance policies and procedures and can also assist during an FDA audit process to minimize compliance risks. Contact your account manager to learn more.