WHY GDP?
Used in the Medical Industry to define the standards for all documentation
What are GDPs?
Clear
What is Legible?
A duplicate that must be stamped, initialed and dated
What is a copy?
05.APR.2025 or 2025-05-05
What are the approved date formats?
Substance Used to hide writing
What is White Out?
An Organized form of information that can serve as legal evidence
What is Documentation?
Correct and Complete
What is Accurate
Before you start YOUR operation.
What is checking the previous operation for GDP?
Proper method to correct a documentation error
What is a single line cross out, initials and date?
Putting an earlier date than the correct date
What is Back Dating?
The purpose of GDP.
What is assures the quality and integrity of Abiomed's Documents.
First Recording or Unaltered
What is Original
The Overall Accuracy, Completeness and Consistency of data
What is Data Integrity?
Black and Blue
What are the acceptable ink colors?
A place where data or observation should not be recorded
What is a Sticky Note or Scrap Paper.
SOP-QA39
What is ABIOMED's SOP on Good Documentation Practices?
In Real time
What is Contemporaneous?
Entries are timestamped in order
What is consistent?
The person who witnesses the performer complete a GMP task. This person is also trained in the process and is able confirm and document that the task has been completed correctly
Who is the Verifier "reviewed by"?
Area left blank on a page needs...
an “N/A” (not applicable), initial and date the annotation, unless permitted to be left blank by the form/document/procedure
Scrapped Product, Plant Shut Down, Recalls, Fines
What are results of poor documentation Practices
Accessible for Review, Audit or inspection.
What is Available?
Person responsible for ensuring documentation is correct
Who is EVERYONE?
indicates that the person agrees with the information provided or conclusions in the record and is accountable for the documents
What is your signature?
Action of recording inaccurate results that will lead to disciplinary actions taken?
What is falsifying data?