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Top 12 Acronyms & Definitions in Good Documentation Practices GDP.

GOOD DOCUMENTATION PRACTICES GDP DEFINITIONS AND ACRONYMS

 

In this article, you will learn about the 12 Most Typical Definitions & Acronyms in 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.

The following definitions and acronyms apply to Good Documentation Practices:

Acronym Definition
1.   Original Data (Raw Data) Data recorded as a result of a performed or observed activity. Examples: Current information recorded such as values or measurements of test results, temperature readings, times and dates, investigation reports, and information used to determine the acceptance or rejection of product manufactured.
2.   Common Password An electronic data entry to control access to a piece of equipment where this level of access does not create, store or modify quality records. This is not specific to an individual user.
3.   Digital Signature An electronic signature based upon cryptographic methods of originator’s authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified in a trustworthy and reliable manner.
4.   Done by/Performed by: Identifies the individual that executes a task. Signature of the person executing a procedure, operation, calculation, etc. that is being documented. This person is responsible for the action performed.
5.   Prepared by: Signature of the person writing a memo or report of an event being documented.
6.   Signature/initial A combination of the individual’s signature or initials and date. The signature/initial must be the same as the one officially registered.
7.   Reviewed By The act of ensuring that the record is correctly completed and in accordance with the Good Documentation Practices. The assessment made on recorded data to verify correctness against the pre-defined requirements.  Signature of the designated person responsible for the revision of the document.  This person certifies that the document contains accurate calculations, that the data is complete, and that the documented information is correct and free of errors according to the applicable procedures/specification and the Good Manufacturing Practices (GMP) specified in this procedure. This person is responsible for what is being signed although he/she did not perform the work.
8.   Verified By To prove to be correct. Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.  Signature of the designated person that usually verifies that the performance of the activity and assures that it has been carried out according to the applicable procedures/specification and the GMP specified in this procedure.  The person that verifies must be present during the operation unless electronic or instrumental documentation provides evidence that the activity took place.
9.   Recorded By Identifies the individual that records data or any other information.
10.   Approved by: Signature of the designated responsible person for the content of the document or report being evaluated, certifying that the documentation or disposition entered is correct. This person is responsible for what is being signed although he/she did not perform the work.
11.   Document An approved instruction either in paper or electronic form which guides about how an activity shall be executed.
12.   Record A record is often considered a document.  Records provide evidence that activities have been performed or results have been achieved. They always document the past.

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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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Quality procedures templates

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REFERENCES:

For more information about Definitions in Good Documentation Practices GDP, 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 – Definitions in Good Documentation Practices GDP

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
Picture of Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!

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