2-QA-001
(Use of Logbooks)
10-QA-004 (Change Control)
2-QA-010 (Deviations
10-QA-008 (GDP)
2-QA-005
(Part and Lot Numbers)
100
This many entries are allowed in the logbook for labs under line clearance
What is 1
100
Go to this guy with any change control questions
What is David Correa
100
An atypical, abnormal, or unplanned incident or event
What is a deviation
100
To witness, supervise, or check another individual's observation and calculation
What is verify
100
Identify the abbreviation: 1-CSM
What is Customer Specific Material
200
This activity is captured in logbooks
What is USE or CLEANING or MAINTENANCE
200
Equipment under change control may need to be tagged with this
What is RED tag or DO NOT USE tag
200
The specific underlying cause for a deviation
What is root cause
200
The two allowable colors of ink
What is blue and black
200
Identify the abbreviation: 4-ER
What is Engineering Run (F/F)
300
This group is responsible for issuing logbooks
What is Quality Assurance
300
This group is responsible for assessing the impact of a change to validated equipment/systems
What is Validation
300
This group must be notified of any deviations
What is Quality Assurance
300
These must be placed on all instrument printouts
What are operator's initials and date (printed)
300
Identify the abbreviation: 4-EN
What is Engineering Run (BMG)
400
These documentation practices are required when documenting all entries in logbooks
What is Good
400
This board is made up of members from Validation, Manufacturing, Quality Control, Facilities and chaired by Quality Assurance
What is Change Review Board
400
Short term or immediate action(s) taken to address the definitive or potential root cause(s) for a deviation
What is corrective action
400
All forms must be filled out in this
What is real time
400
Identify the abbreviation: 4-CO
What is Commercial
500
This group is responsible for reviewing logbooks
What is Quality Assurance
500
Change control impacts these types of processes
What is VALIDATED or QUALIFIED
500
The target completion, in days, for deviations
What is 30
500
1.249 rounded to 2 significant digits
What is 1.2
500
Identify the abbreviation: 1-FP
What is Final Product [specification]
Click to zoom
M
e
n
u