Best 8 Practices Documenting Missing Data in GDP.

In this article, you will learn how documenting missing data according to the Good Documentation Practices GDP as per FDA requirements.  Moreover, you can discover how to get a Document Management and Control Procedure Template and Document Management Software Application to handle your training activities fast and easily.

Best 8 GDP Practices Documenting Missing Data.

Missing data detected during the subsequent review, other than inspection and test results, can be added provided that:

1. The missing data can be verified.
2. The individual who performed the recorded task or the individual’s supervisor (or designated leader) provides it.
3. The new entry should be annotated as entered by the person who provided it.
4. The dates provided are current and never prior, and an explanation next to the entry is provided.
5. The missing entry is provided on the original and not a reproduced copy unless the original is annotated to include a reference to the completed copy.
6. Use the abbreviations mentioned below to cancel the blank space or section. Draw a diagonal line from the top to the bottom of the space or section intended to be invalidated and write the “Not Applicable” abbreviation (N/A). Include initials and date. Once a blank space or section is invalidated it cannot be used. If space or section needs to be used after it has been invalidated, use a numbered asterisk (*1) outside of the box and document the applicable information.
7. Empty spaces in the following instances do not need to be invalidated
   • Comments section
   • Multiple choice documents; do not invalidate the ones not selected.
8. When a form provides a data entry table and a section for signature and date, blocks within the table can be invalidated using N/A without adding initial and date.

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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REFERENCES:

For more information about Good Documentation Practices GDP – Documenting Missing Data, 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 – Good Documentation Practices GDP – Documenting Missing Data

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