Predicate Rule Signatures in Life Sciences

Predicate rules are the requirements found in part 21 of the Code of Federal Regulations (CFR). They are promulgated under the authority of the Food Drug and Cosmetic Act or under the authority of the Public Health Service Act. The most well-known are the cGMP regulations 21 CFR 210, 21 CFR 211, 21 CFR 600 for Biologics and 21 CFR 11 for Electronic Records: Electronic Signatures.

The Predicate Rules require approval signatures on controlled documentation such as Standard Operating Procedures (SOP) and Master Control Records.   Pursuant to the Good Documentation practices the meaning of the approval signature is included with the signature.  For example, by approving an SOP by the Quality Assurance Unit it may approve the procedure for use.

In the electronic environment manufacturing environment Syncade provides the ability to configure the signature meaning with each specific action performed.  The signature meaning is displayed in the electronic signature dialog when the action is performed and easily configured in the Syncade Language Engine.

For further information on documentation and signature requirements Kathie Clark of NextDocs provides further a great overview in her article entitled  FDA & EU Requirements for Documentation & Approval of GMP Procedures

Share some of your questions around prediicate rules and signature requirements.

2 Replies

  • I also found references to the signature meaning in 21 CFR Part 11.50 (a) 3 as excerpted below when dealing with approvals and electronic data.

     

    TITLE 21--FOOD AND DRUGS
    CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
    SUBCHAPTER A--GENERAL

    PART 11 -- ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

    Subpart B--Electronic Records

    Sec. 11.50 Signature manifestations.

    (a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:

    (1) The printed name of the signer;

    (2) The date and time when the signature was executed; and

    (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.

    (b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).

  • In reply to Chris Amstutz:

    I've just been informed that there are no restictions on the text string configured as part of the signature meaning.  However, as the string gets to long to fit in the dialog box it will wrap making it harder for the user to understand the signature meaning.