GLP / 21CFR Part11 compliance

At Notocord we do care about safety, security and traceability. Our software NOTOCORD-hem Evolution® fulfills GLP requirements and 21 CFR Part 11 compliance is achieved by using AccessManager (AMG), our highly secure and compliant security application.

GLP installation of NOTOCORD-hem™ Evolution adds access control and audit trail functionalities providing security of electronic records, restricted access to authorized individuals, and allowing the use of electronic signatures.

Example GLP installation in NOTOCORD-hem Evolution

Access control & audit trail

The highly secure AccessManager and LabManager application are designed for data streams and video streams respectively. They provide access control and audit trail of actions, as well as data approval process.

Access control settings with AccessManager

Access control relying on authentication parameters such as username, password and comment, may be shared by several networked workstations running NOTOCORD-hem™.

The Audit Trail records actions performed by identified users in the course of data acquisition and analysis.
Traced infomation includes the nature of the action/change, date and time stamp, the user's identity and comments, and old and new values. Advanced security features ensure the audit trail cannot be altered.

The LabManager application defines a security strategy for actions related to video streams. It ensures access control, with user permissions, and traceability of actions carried out with NOTOCORD® video modules.

Certification

NOTOCORD®'s software development is performed in an ISO 9001:2008 certified environment. Our certification ensures that our released software has gone through extensive tests using an advanced set of tools and resulting in an extremely stable product.

Keywords

  • GLP compliance
  • Access control
  • Audit trail
  • Shared policy
  • Data approval