TEKLYNX CENTRAL Not Requiring Electronic Signatures – TEKLYNX CENTRAL Problem

Target Audience: Advanced User

Article #: 13878

Summary

In CRF 21 Part 11, the FDA requires companies using electronic means to control and track label changes to use a system that allows for Electronic Signatures. TEKLYNX CENTRAL does meet this requirement. However, to activate this feature, the user must set up and use Approval Rules.

Situation and symptoms

  • Using LABEL ARCHIVE component of TEKLYNX CENTRAL to store and control label designs.
  • 3-Stage Approval selected in settings.
  • When doing a ‘Check-in’, no additional authentication (i.e., electronic signature) appears.

Explanation

TEKLYNX CENTRAL meets the CRF 21 Part 11 requirement by prompting the user to re-authenticate when approving a draft version of a label. However, this only happens when using the Approval Rules feature. When using Approval Rules, TEKLYNX CENTRAL requires ALL approvers to re-authenticate when approving thus meeting the CFR 21 Part 11 requirement.

Figure 1 – Approval Rule Pops Up when Assigned to the Label

Solution

Start using the Approval Rules feature in TEKLYNX CENTRAL for CRF 21 Part 11 compliance.

The TEKLYNX CENTRAL Administrator must set up the rules in TEKLYNX CENTRAL first. These rules will determine who needs to approve a label and in what order to execute the approvals. TEKLYNX CENTRAL can support many different approval rules.

When a new draft is created, the TEKLYNX CENTRAL Design User will specify which Approval Rule (previously setup by the TEKLYNX CENTRAL Administrator) is required for that label. Once specified, all approvers for that label MUST authenticate (i.e. type in password) during the approval process. Thus compliance with electronic signatures is assured.

Figure 2 -‘ Confirm password’ Pops up if the Label Designer Assigned an Approval Rule to that Label

Additional comments

Issue Found: TEKLYNX CENTRAL v6 and v7

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