The amount of time you have to open a deviation from the date of discovery
What is 1 business day
100
Metadata
What is data about the data
100
The three categories of laboratory equipment classifications
What are category A, B, and C
100
The GDP SOP
What is FWMDOC-02107
100
Observations noted by the FDA during an audit is cited on this
What is a Form 483
200
Number of days to close a LNC from time of discovery.
30 calendar days
200
At the time it happens
What is contemporaneous
200
The procedure for laboratory equipment qualification
What is FWMDOC-04003
200
The types of pens allowed to be used when completing documentation
What is blue or black indelible ink
200
The four things needed to make a correction to a document
What are the ability to read the initial entry or a single cross-out, explanation of correction, signature and date
300
The three classifications of non-conformances
What is Minor, Major and Critical
300
Name two items that are forbidden to be used when recording data
What are pencils and correction fluid
300
Lab equipment that does not allow for unique login requires a _____ _____.
What is a Use Log
300
Person who witnesses an operation, task or step
What is Checked by or Verified by
300
The opening in the top of a barrel or drum
What is a bung.
400
Level of approval required to extend a critical non-conformance
Who is Site Quality Head
400
The acronym ALCOA
What is attributable, legible, contemporaneous, original, and accurate
400
The category type that provides measured values, controls physical parameters and requires calibration.
What is Category B
400
Must be N/A'd
What are unused spaces
400
A sterility assurance program where demonstrated control of the sterilization process enables a firm to use defined critical process controls in lieu of the sterility test.
What is Parametric Release.
500
An action to eliminate the cause of an existing deviation or defect in order to prevent recurrence
What is a Corrective Action
500
The acronym CACE
What is complete, available, consistent and enduring
500
Electronically shows who did what, when and why
What are Audit Trails
500
Predicate Rule
What is any requirement set forth in the federal Food, Drug and Cosmetic Act, the Public Health Services Act or any FDA regulation other than 21 CFR Part 11.
500
The Code of Federal Regulations that made electronic records and signatures as valid as paper records and handwritten signatures