For accountability as well as traceability, data collection sheets should
have a unique identifier and the pages should be numbered appropriately.
Brenda Pillari-Soheily, PhD
BD
410-316-4369
Aaron Hubbell <[log in to unmask]>@MICROBIOL.ORG> on 11/13/2002
10:37:56 AM
Please respond to The Pharmaceutical Microbiology Mail List
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Sent by: The Pharmaceutical Microbiology Mail List <[log in to unmask]>
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Subject: Re: [PMFLIST] Tracking of loose data collection sheets
Janet--
In my environmental monitoring lab, a procedure governs the generation,
use, and control of datasheets. They are loose datasheets (not hardbound in
a notebook, although that would be an easy way to establish control). Here
is the flow:
1. Change control (local lab-specific) governs the creation/revision of
datasheets.
2. Each datasheet type (e.g. environmental monitoring of room X) receives a
discrete code identifying that datasheet.
3. The original is approved (documented on that original) and is assigned a
revision number to be retained in the GMP library.
4. Datsheets for use are made from the original, with sequential numbers on
each datasheet. There is a log where the person making the copies signs
that they created so many copies (e.g. AGH created datasheet X, numbers
00031-00060).
5. A second log is used to document who used each datasheet and when.
6. Missing or destroyed datasheets are then handled by the applicable
incident reporting system.
7. Unused datasheets (due to revision or retirement) may be disposed of in
a confidential manner, as long as it is documented as such on the datasheet
signout log.
8. We make 30 datasheets at a time, and audit the log once the 30 have been
used.
This is the flow in my lab, which may or may not be applicable for your
use. But in general, the regulatory agencies are concerned about datasheet
control in a cGMP environment. I hope this helps.
Aaron Hubbell
Environmental Monitoring Microbiologist
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Janet Batterson
<[log in to unmask] To:
COM> [log in to unmask]
Sent by: The cc:
Pharmaceutical Subject:
Microbiology Mail [PMFLIST] Tracking of
List loose data collection
<[log in to unmask] sheets
G>
11/13/2002 08:55 AM
Please respond to The
Pharmaceutical
Microbiology Mail
List
Hello to all!
I have been asked to pose a question to the group to see what is commonly
being done in regards to the use, in particular the tracking, of loose data
collection forms in a GMP environment. (It is understood that change
controls are in place for forms).
The main question is ... Say 100 blank copies of a form were generated for
general use, is it a common, or recommended, practice to number each of the
100 so that each form can be tracked or accounted for in some way? Does
anyone have any history with this, pro's, cons?
Thanks in advance,
Janet Batterson
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