How does NOTOCORD allow you to be 21 CFR part 11 compliant?
17 Jan 2015

NOTOCORD just released the 21 CFR Part 11 Checklist guide describing how NOTOCORD-hem software allows you to satisfy each requirement. This document gathers all relevant information to evaluate NOTOCORD-hem software compliancy with 21 CFR Part 11 regulation. It can be part of your own supplier evaluation program.

This checklist addresses people in charge of computer system validation, GLP study directors, QA managers in charge of audits. It aims at gaining time in the validation process and give confidence about NOTOCORD methodology.

Below you will find a sample of 21 CFR Part 11 checklist:

21 CFR Part 11 requirements NOTOCORD© compliance to 21 CFR Part 11
§ Requirement Yes No Comments

11.100

 

(a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.

X

 

The users’ security for NOTOCORD-hem is based on the Microsoft Windows security (Windows Group Policy and Active Directory), so that unique user IDs and passwords are enforced.

It is not possible to delegate or assign an electronic signature to someone else.

Configuration of user accounts and passwords are managed by the Standard Operating Procedures (SOP) of the ORGANIZATION.

 

Moreover, the document contains dedicated appendices focusing on:

  • Data authenticity and integrity
  • User security and limited access to the system
  • Audit trail
  • Electronic signatures
  • Records in human readable form
  • Validation

> Download Guide: 21 CFR Part 11 Checklist (PDF)

 

21 CFR Part 11 in brief

21 CFR Part 11 is a rule contained in the Code of Federal Regulation (CFR), entitled “Electronic Records; Electronic Signatures” and edited by the United States Food and Drug Administration (FDA).

The challenge of the 21 CFR Part 11 is to give confidence in the electronic records and electronic signatures. Therefore additional controls for computer systems maintaining electronic records are required, including validation of these computer systems.

This regulation applies to all laboratories regulated by the FDA and working in GxP, therefore it is applicable to the use of NOTOCORD-hem software system in GLP environment.

NOTOCORD® understands the complexity of implementing 21 CFR Part 11. Being compliant is a criterion that we have kept in mind when developing NOTOCORD-hem.

> Read more about 21 CFR Part 11 regulation