Good Documentation Practices (GDocP)

Good Documentation Practices – General Rules of Data Integrity

This training program will detail best practices for documentation, list types of documents, and highlight key documentation requirements. Documentation is essential where FDA and other health authority regulations impose a special record-keeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDocPs) are a set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.

CEU Credits: 0.1
Course Code: ELM-501
Duration: 30 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Overview
Learning objectives
Who should take this course?
Course modules
Overview
What are Good Documentation Practices (GDocP)?
Examples
Entire document life cycle
Create a SOP
Benefits of GDocP
Overview
Document Types
Fundamentals of Good Documentation Practices - Part 1
Fundamentals of Good Documentation Practices - Part 2
Signatures
Document control
Minimum number of approvers
Never back date!
Specimen file
Electronic systems
Date and time format
Good practice
Be consistent
Format
Languages - Correct grammar
Use indelible ink
Do not
Blue of black
Scrap paper and post-its
Transcribing
Late Entries
Blank fields
Annotations
Additional pages
Instrument print-outs
Ditto

Conclusion

Final Assessment

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group

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