FDA 21 CFR Part 11 Compliant

TMSWeb Quality Compliance Management System is fully compliant with FDA 21 CFR Part 11 requirements and regulations for electronic records and electronic signatures.  Compliance is a major focus of TMSWeb and QSI has actively worked with industry committees to provide complete and secure solutions to assist regulated companies. Adherence to the requirements of 21 CFR Part 11 and other standards is imperative to the success of organizations.
TMSWeb Quality Compliance Management addresses the following key areas:
  • Records Management (Accurate and Readily Retrievable)
  • Document Management (Revision and Change Control)
  • Training Management (Job Training and Certifications)
  • System Security (Authorized and Permission Based Access)
  • Secure Audit Trails (Confirms the Integrity of Records)
  • Electronic Signatures with Date/Time Stamp (Trustworthy and Reliable)
  • System Validation (Certifies Consistency and Reliability)