Footnote Jeopardy

Footnote Abbreviations

100

CE

Calculation Error

200

EODC

End of Data Collection

300

ILL

Illegible

400

INDA

Incorrect Data

500

INFI

Incorrect Field

Footnote Abbreviations P2

100

Incorrect Format 

INFM

200

Inadvertently Omitted at Time

IOT

300

Line Not Used 

LNU

400

Rewritten For Clarity 

RFC

500

Verified BY

VB

Random Questions 1

100

Handwritten entries must be made in ____ or ____ ink. 

Black / Blue 

200

Signing for work that was not performed is - 

Fraud / Falsification 

300

Individuals performing documentation must be appropriately _____ on procedures involved.

Trained / Qualified 

400

How many signatures does a *After the Fact* Footnote need?

2

500

Name 5 *After the Fact* Verified by -  Credible Sources 

SCADA, Avigilon, LUMAC, Protocols, PRs

Random 2

100

Verify accuracy of ALL calculations present (time, quantity, vial and solution accountability, etc.) and are within acceptable limits as stated on BPR or CPR. Refer to client specific SOP’s Attachment __ for critical time frames.

1

200

Who closes out the end time in the LUMAC 

Whoever completed the last task 

300

If you are unsure what to do about a correction you should - 

A. Leave it all blank 

B. Be overly vague and forget to sign 

C. Discuss with your Specialist / other techs and make sure you are short, clear, verifiable  and precise 

C

400

All CMO personnel are responsible for ensuring training has been completed and adequately documented in LMS _____ to performing any GMP activity.

prior / before 

500

What is the Acronyms SOP #

001144

Definitions

100

Data that is reliable, complete, free of errors, and an exact representation of facts.

Accurate

200

Individual who observes and verifies the task being performed in real time by another individual or individuals. Data is not independently recorded to be verified later.

Witnessed BY

300

Individual who independently verifies that a task was correctly performed per procedure by another individual or individuals. Verification can be performed in real time or after the fact, including calculations

Verifier/Checker/Verified By

400

Individual performing work per BPR/SOP instructions and records all data related to work performed. If more than one individual participates in performing a task/step, each must sign the record and identify which data is applicable to who.

Operator/Performed By

500

Data is traceable to the person documenting the data or performing/verifying a task.

Attributable