ALCOA+
What does the first A in ALCOA+ stand for?
Accurate
What is the proper date format?
2 Digit for the day
3 Alpha characters for the month
2 or 4 Numerical digits for the year
Ex: 28Feb2024
What color ink can we use to document with?
Black and/or Blue
What information needs to be included in a footnote?
Description, Initial, and Date.
Name a validated GMP system used at our site.
MES, SAP, ELIMS, EMS, TruVault, Nucleocounter, Maximo
What does the O in ALCOA+ stand for?
Original
Can you document an activity, if the documentation for a prior activity is incomplete?
No.
What is the shortcut to lock your computer?
Press down on the windows key while pressing the L button.
The first step is to verify the sequential footnote reference number for the page.
Can we reference time using network clocks?
Yes, only if it is a GMP network since systems can be calibrated.
You have messy handwriting, what ALCOA+ principal does this violate?
Legible.
Can you use abbreviations such as EE (entry error) when correcting a mistake?
No.
If unsure how to complete/document a task, what should you do?
Ask for help.
If you are referencing a separate logbook in a footnote, what information needs to be included in the footnote?
Logbook and page number.
What is a CGMP source?
CGMP sources are qualified systems and established documentation that support and comply with cGMP requirements.
An associate documents a prior date and time for a task that has not been completed yet. What ALCOA+ principal does this violate?
Contemporaneous
Where should you retrieve information when documenting a late entry?
The applicable GMP source.
If you sign off on results/data electronically using your username and password, does this hold the same value has a handwritten signature?
Yes. An electronic signature holds the same value as handwritten.
Can you use the same footnote reference for multiple errors?
Yes, only if it is the same type of error.
Which of the following is NOT a validated GMP source?
A. Microsoft Word
B. Sharepoint
C. Powerpoint
D. All of the above
D. All of the above.
State what the + in ALCOA+ stands for and give an example
complete, consistent, enduring, available
List the steps to correct a mistake. Hint: 3 Steps
1. Single line cross through incorrect data.
2. Write correct information near the mistake, initial and date.
3. Add comment if necessary.
If applicable reference GMP source.
If a printed GMP document is used during your workday, what should do you with the document at the end of the day?
All documents should be disposed in secure locations at the end of each work day.
Jimmy (initials: JM) is filling out an entry in a logbook and accidentally wrote a 2 instead of a 3 when writing a lot number for a reagent.
Which of the following footnote descriptions is written correctly?
A. Entry Error. JM 29Feb2024
B. EE. JM 29Feb2024
C. Incorrect lot number written. JM 29Feb2024
D. Inadvertently wrote a 2 instead of a 3. Correct lot number referenced XXXX. JM 29Feb2024
D. Inadvertently wrote a 2 instead of a 3. Correct lot number referenced XXXX. JM 29Feb2024
Can excel be a validated GMP source?
Only if it has been validated.