The Best 12 GDP Practices Making Signatures and Approvals.

In this article, you will learn how to implement the top 12 GDP best practices making signatures and approvals in compliance with Good Documentation Practices GDP as per FDA requirements.   Moreover, you can discover how to get a Document Management Procedure Template and Document Management Software Application to handle your training activities fast and easily.

1. Always read the entire document before signing. An individual’s signature on a document indicates the individual’s review, understanding, and approval of the document.
2. The signature signifies that the contents of the document (including objective evidence/supporting data) fulfill the requirements of the individual’s specific functional area to the best of their knowledge.
3. An individual should not sign for another individual unless the person authorizing the delegation provides a signature delegation in writing. Delegation can also be accomplished through a validated electronic quality system.
4. An individual should not transfer the signature delegation assigned to him/her. In cases where the individual who is assigned the signature delegation is unavailable, the signature of the original signatory’s supervisor or higher may be obtained.
5. When dating a signature, the date used should be current and never prior or future.
6. Initials alone are not permitted where a full signature is required unless specifically allowed by the document/procedure and a full signature appears in the same document or is retrievable via a signature log.
7. In general, if a signature is not legible, the name must also be printed.
8. Copies, faxes, or digitally scanned images of original signed forms (manual signatures) are acceptable records.
9. The electronic copy/version of a document digitally signed with a PKI signature is a legitimately signed quality record (e.g. an acrobat file with a signature unit). A printout for the above quality record must be signed through alternative means (e.g. manual signature).
10. It is not acceptable to use an associate’s number in place of a signature when a handwritten signature is required on a record.
11. Signatures may be collected either electronically (e.g. DocuSign, encrypted PKI token) or by permanent ink pen and hardcopy paper.
12. Meeting facilitators can record and sign attendance sheets/meeting minutes to confirm that attendees were present unless otherwise stated in an individual procedure. These signatures only indicate presence at the meeting.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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Three (3) Options to Create Document Control Management DCM Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

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To see the complete list of the most popular quality procedures templates, click here.

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This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Procedures.

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REFERENCES:

For more information about GDP practices making signatures and approvals-Good Documentation Practices, refer to:

httpss://www.fda.gov/files/drugs/published/Data-Integrity-and-Compliance-With-Current-Good-Manufacturing-Practice-Guidance-for-Industry.pdf

TITLE 21–FOOD AND DRUGS

SUBCHAPTER A–GENERAL

PART 11  ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

httpss://clarkstonconsulting.com/insights/guidance-data-integrity/

https://www.climet.com/data-integrity/

https://www.biopharminternational.com/data-integrity-electronic-records-according-21-cfr-part-11

httpss://www.pda.org/docs/default-source/website-document-library/chapters/presentations/missouri-valley/data-integrity-issues-concernse703e9d7a8c4657391feff0000cd242a.pdf?sfvrsn=4

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://www.fda.gov/media/118202/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.40

QS Regulation and Guidance • Quality System Regulation and Preamble –  GDP- practices making signatures and approvals- Good Documentation Practices.

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

Inspection Guide – Pages 8, 15, 21, 22 and 23

httpss://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm

Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]

www.fda.gov/iceci/inspections/inspectionguides/ucm074883.htm