Data Integrity and Compliance With CGMP
Guidance for Industry
TABLE
OF CONTENTS
I.
INTRODUCTION.......
1
II.
BACKGROUND..............
1
III.
QUESTIONS AND
ANSWERS........
2
1.
Please clarify the following terms as they relate to CGMP
records:................2
a.
What is “data integrity”? .2
b.
What is “metadata”?
..................3
c.
What is an “audit
trail”?.....................3
d.
How does FDA use the terms “static” and “dynamic” as they relate to record
formats? .............3
e.
How does FDA use the term “backup” in §
211.68(b)?..........................4
f.
What are the “systems” in “computer or related systems” in §
211.68?..................4
2.
When is it permissible to exclude CGMP data from decision
making?...............4
3.
Does each workflow on our computer system need to be validated?
.........4
4.
How should access to CGMP computer systems be restricted?
...5
5.
Why is FDA concerned with the use of shared login accounts for computer systems?...........6
6.
How should blank forms be controlled?
................6
7.
How often should audit trails be
reviewed?.......................6
8.
Who should review audit
trails?.......................6
9.
Can electronic copies be used as accurate reproductions of paper or electronic
records? .....7
10.
Is it acceptable to retain paper printouts or static records instead of
original electronic records from stand-alone computerized laboratory
instruments, such as an FT-IR instrument? .7
11.
Can electronic signatures be used instead of handwritten signatures for master
production and control
records?..........................8
12.
When does electronic data become a CGMP record? ................8
13.
Why has the FDA cited use of actual samples during “system suitability” or
test, prep, or equilibration runs in warning
letters?..............................9
14.
Is it acceptable to only save the final results from reprocessed laboratory
chromatography?
.......................9
15.
Can an internal tip regarding a quality issue, such as potential data
falsification, be handled informally outside of the documented CGMP quality
system?........9
16.
Should personnel be trained in detecting data integrity issues as part of a
routine CGMP training program?
.................10
17.
Is the FDA investigator allowed to look at my electronic
records?............10
18.
How does FDA recommend data integrity problems identified during inspections,
in warning letters, or in other regulatory actions be addressed?
..................10
