Question 11: Where is data stored?
Best Answer: Storage of data (paper or electronic) should be at secure
locations, with access limited to authorized persons. The storage location must
provide adequate protection from damage due to water, fire, etc.
Question 12:
What are the measures
protecting against loss or unauthorized amendment?
Best Answer: Data security measures should be at least equivalent to those applied
during the earlier Data lifecycle stages. Retrospective data amendment (e.g.
via IT helpdesk or data base amendments) should be controlled by the
pharmaceutical quality system, with appropriate segregation of duties and
approval processes.
Question 13:
Is data backed up in a
manner permitting reconstruction of the activity?
Best Answer: Back-up arrangements should be validated to demonstrate the
ability to restore data following IT system failure. In situations where
metadata (including relevant operating system event logs) are stored in
different file locations from raw data, the back-up process should be carefully
designed to ensure that all data required to reconstruct a record is included.
Similarly, 'true copies' of paper records may be duplicated on
paper, microfilm, or electronically, and stored in a separate location.
Question 14:
What is data retention
period?
Best Answer: This will be influenced by regulatory requirements and data
criticality. When considering data for a single product, there may be different
data retention needs for pivotal trial data and manufacturing process /
analytical validation data compared to routine commercial batch data.
Question 15:
How data disposal is
authorized?
Best Answer: Any disposal of data should be approved within the quality system
and be performed in accordance with a procedure to ensure compliance with the
required data retention period.
Question 16:
How should the company design and control their paper
documentation system to prevent the unauthorized re-creation of GMP data?
Best Answer: The template (blank) forms used for manual recordings may be created
in an electronic system (Word, Excel, etc.). The corresponding master documents
should be approved and controlled electronically or in paper versions. The
following expectations should be considered for the template (blank) form:
·
have a unique reference number (including version number) and
include reference to corresponding SOP number
·
should be stored in a manner which ensures appropriate version
control
·
if signed electronically, should use a secure e-signature
The distribution of template records (e.g. 'blank' forms) should
be controlled. The following expectations should be considered where
appropriate, based on data risk and criticality:
·
Enable traceability for issuance of the blank form by using a
bound logbook with numbered pages or other appropriate system. For loose leaf
template forms, the distribution date, a sequential issuing number, the number
of the copies distributed, the department name where the blank forms are
distributed, etc. should be known
·
Distributed copies should be designed to avoid photocopying either
by using a secure stamp, or by the use of paper color code not available in the
working areas or another appropriate system.
Question 17:
What controls should be in
place to ensure original electronic data is preserved?
Best Answer: Computerized systems should be designed in a way that ensures
compliance with the principles of data integrity. The system design should make
provisions such that original data cannot be deleted and for the retention of
audit trails reflecting changes made to original data.
Question 18: Can
you have a shredder in production?
Best Answer: I would propose that the shredder should only be available to Quality Unit
employees so that you carefully control access and thereby can better control
which documents are shredded.
Question 19:
Is it ok to correct an error in a
record with initials and date?
Best Answer: Actually, I am never asked that question. Instead, when during an audit I
challenge corrections missing the reason for the change in information I am
regularly told “the error is initialed and dated and that’s our SOP.”
This too is cultural. We shouldn’t hide behind an SOP.
If a number, or any other piece of information is altered from the original
paper record (if computer, there should be an audit trail and the audit trail
should be provided – electronically or as a printout, with the record), the
reason should always be documented.
If I need to release a batch, and
someone altered a yield calculation or a time or date on an entry and I don’t
know why they did that or on what data they relied…I have a data integrity
issue.
Question 20:
When software is updated my, how much revalidation is required?
Best Answer: The FDA guidance: General Principles of
Software Validation focuses on two points related to revalidation. First,
changes to the system must be evaluated for their relative impact to the
particular company’s intended use for the system.
For example, instrument support
functionality changes may not be related to a user’s particular instrument
configuration or may reflect unused features. From the vendor’s release
documentation, it should be possible to determine what features and
functionality have been updated, and what defects in the software have been
corrected.
Any changes should be compared against the intended use to determine
any revalidation impact.
Second, whenever software is changed, the
user should evaluate the change themselves, including some degree of regression
testing to confirm that the change in the software or the updated software has
not broken something else in some way that may have had unintended
consequences.
It is not uncommon, for example, when
updating software for home computers or phones to find that features that
worked before the update may not work afterwards.
“Trust but Verify “ Ronald Reagan
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