Electronic record and document content management system with 21CFR Part11 Compliance And Electronic record and document content management system with 21CFR Part 210-211 Compliance

To avoid or minimize these risks, life sciences organizations should adopt new information management strategies. The clear and proven path is the electronic record and document content management system. These systems enable the organization to manage their information throughout project inception, creation, review, processing, transmission, storage, as well as the archiving and dissemination phases. This approach offers a systematic and procedurally sound approach to the unique needs of product development and life cycle management in the life sciences.

SoluSoft Solution for 21CFR Part 11/ 21CFR Part 210-211 Compliance

The electronic form, document or records that are created, modified, maintained, archived, retrieved or transmitted under any records requirements set forth in FDA regulations is part of this solution. The technical and procedural controls for 21 CFR Part 11/210-211 Compliance enforce controls on information access, change management, tracking, notification, training, work flow and administrative controls on authentication, authorization and integrity of records.

Benefits of Compliance

  • Authentication: Authorized users allowed access to electronic information
  • Authorization: Only authorized individuals can access certain or complete parts of the information universe
  • Change Control: Ability to track changes to electronic and printed document records (i.e., changes were made by: who, what, when and why?)
  • Retrieval Tracking: Monitor and track the retrieval of the information
  • Workflow: Proactively manage the information life cycle from inception, creation, review, process, transmission, storage, archiving and dissemination
  • Record Authenticity: Digital signature provided to maintain document authenticity and integrity
  • Long Term Storage: Provide archiving, retention and purge capability
  • Protected Transmission: Information transmitted from authors to CRO, to technicians, to reviewers and to consultants is protected via encryption

Business Value

  • Elimination and minimization of regulatory risks, fines and process delays
  • Increase in credibility due to regulatory compliance
  • Minimization or elimination of patent violations
  • Organization and management of structured and unstructured information
  • Enforcement of the best practices to protect the intellectual property of the organization