CAPS
This is what GDP stands for
Good Documentation Practices
GDP ensures we stay compliant with this.
GDP ensures we stay compliant with cGMP and Quality System Regulation.
cGMP stands for
Current Good Manufacturing Practices
A.L.C.O.A stands for
Attributable, Legible, Contemporaneously Recorded, Original or a true copy, Accurate
Knowing who recorded information or what batch data belongs to refers to this term in ALCOA.
Making sure your handwriting can be read by someone else refers to this term in ALCOA.
Legible
These are the acceptable ink colors for documentation.
Blue or Black
This has to be next to any correction or notation
Initials and date
Information being recorded at the same time it occurs refers to this term in ALCOA
Contemporaneously Recorded
The accuracy, completeness, and quality of data as it's maintained over time and across formats is the definition of this term.
Data Integrity
The importance of data integrity impacts these (4) things.
Financial objectives, customer trust, revenue potential, performance.
Making sure information is correct and complete refers to this term in ALCOA
Accurate
These employees are responsible for practicing GDP,cGMP
Everyone
Eliminating/destroying data, intentionally deleting information is considered this
Fraud
A document being in the same condition it was when it was recorded refers to this term in ALCOA
Original (or true copy)
Compounding records, notebooks, lab work, controlled data sheets (ex: cleaning logs) , validation documentation, training documentation
Data must be recorded in
Real time (no backdating or predating)
When making a correction to a mistake in data we must use this
Straight, simple line (no squiggly lines or scribbling data out)
Blank spaces must be filled with this.
Straight line, N/A, initial and date
Proper dating format includes the following.
3 letters for the month, 2 digits for the day, 4 digits for the year