Top 8 Characteristics of Good Documentation Practices GDP as per cGMP.

Top 8 Characteristics of Good Documentation Practices GDP

 

In this article, you will learn the Top 8 Characteristics of Good Documentation Practices GDP & Data Integrity 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.

8 Characteristics of Good Documentation Practices

Employ and implement the following data integrity characteristics in all entries in controlled GxP quality records to prevent them from being misinterpreted:

  1. Permanent: Entries cannot be deleted or modified without displaying the original entry and subsequent changes.  Hand-written or automated/electronic original data should remain legible for the duration of the record retention requirement.
  2. Legible: Capable of being read and deciphered by the reader.
  3. Accurate: Factual, free from error, and consistent with the truth.
  4. Consistent: Demonstrate data continuity and be free from variation in documentation style or contradiction in the message.
  5. Complete: Provide a comprehensive description of the events documented with no gaps, and the information recorded allows others to reconstruct or repeat the work.
  6. Traceable: Capable of determining origin and history of material, component, etc. Ability to be tracked to individuals responsible for observing and recording the data or the sources from which they were obtained. May include such details as “location”, “reference”, “filename”, “date documented”, “date published”, and “date approved.”
  7. Chronological: Consistent and accurate with the order of events.
  8. Specific/Clear: Unambiguous data providing enough detail to allow for identification and traceability of all data sources.

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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

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

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

You can download samples of the Document Control Management DCM procedure templates in .pdf format. 

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

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on Characteristics of Good Documentation Practices GDP.

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.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

GET IN COMPLIANCE TODAY WITH GOOD DOCUMENTATION PRACTICES GDP, CONTACT US (Hablamos Español)

REFERENCES:

For more information about the Characteristics of Good Documentation Practices GDP, refer to:

https://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

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

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

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

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

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

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

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

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

QS Regulation and Guidance • Quality System Regulation and Preamble – Characteristics of 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

https://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

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!