 |
| Data Integrity App |
Question 31:
Best Answer: A single test does not at all fulfil the requirement of ensuring readability. The frequency of testing depends on different factors such as the archived process and the software and hardware used and should, for logical reasons, be defined individually.
A single readability test is definitely not enough, since the aging process of the data storage devices and the disk drives used cannot be taken into account in that case.
Furthermore, the availability of the requisite hardware and system software can play an important role as regards very old systems. This is the reason why periodic control of readability is indispensible.
Question 32:
Which kind of media (CD Roms, WORMs, etc.) can be considered “21CFRPart11 compliant” from point of view of good retention period?
Best Answer: In an effort to remain
technologically neutral, the FDA does not specify the kind of media that one
must use for archiving.
There are studies currently underway
from independent sources that are trying to test the ‘lifetime’ of such media
as CD ROM, although there is no set standard lifetime for such media.
Some companies are doing their own
tests on media lifetime.
Question 33:
If a GLP computer is in a lab with physical access control to the doors to the lab, but the application software on that lab computer has no logical access control, does this system comply with Part 11?
Best Answer: No. This is because there would be
no way to control access to the system itself. There would be no record of who
actually logged onto the system and when.
Question 34:
Is a ‘Gap Analysis’ a necessary step to become 21 CFR Part11 compliant?
Best Answer: A Gap Analysis is not a specified
requirement of Part 11, however, during the process of becoming Part 11
compliant, most firms undergo a Gap Analysis as part of their
assessment/remediation phase.
Question 35:
What is the definition of hybrid system? Could you give an example of one?
Best Answer: A ‘Hybrid System’ is defined as an
environment consisting of both Electronic and Paper-based Records (Frequently
Characterized by Handwritten Signatures Executed on Paper).
A very common example of a Hybrid
System is one in which the system user generates an electronic record using a
computer-based system and then is required to sign that record as per the
Predicate Rules (GLP, GMP. GCP).
However, the system does not have an
electronic signature option, so the user has to print out the report and sign
the paper copy.
Now he has an electronic record and
a paper/handwritten signature. The ‘system’ has an electronic and a paper
component, hence the term, hybrid.
Question 37: If using a ‘hybrid system’ approach to e-signatures, how do you link the handwritten signature to the e-record?
Best Answer: Since Part 11 does not require that
electronic records be signed using electronic signatures, e-records may be
signed with handwritten signatures that are applied to electronic records or
handwritten sign atures that are applied to a piece of paper.
If the handwritten signature is
applied to a piece of paper, it must link to the electronic record.
The FDA will publish guidance on how
to achieve this link in the future, but for now it is suggested that you
include in the paper as much information as possible to accurately identify the
unique electronic record (e.g., at least file name, size in bytes, creation
date and a hash or checksum value.)
Hoverer, the master record is still
the electronic record. Thus, signing a printout of an electronic record does
not exempt the electronic record from Part 11 compliance.
Question 37:
What are some examples of audio data that may be captured in the Pharmaceutical Industry? Specific Examples?
Best Answer: Audio recordings of regulated
patient information or experimental observations are infrequent, but sometimes
acquired. Also, audio conferences discussing projects, reports, data are common
in the pharma industry.
If the data therein is required to
be maintained by predicate rules, and the audio file is saved to durable media,
Part 11 would apply.
Question 38:
Are e-mails controlled documents?
Best Answer: If the text in an email supports
such activities as change control approvals or failure investigations, then the
e-mails have to be managed in a compliant way.
Question 39:
FDA has issued a new guideline on date and time. It is not mandatory that it is local?
Best Answer: You are correct. The just-released
draft Guidance Document on Time Stamps for E-Records and E-Sigs can be found
here.
The Agency has reconsidered their
position on local date and time stamp requirements.
The draft guidance document reflects
their current thinking, and supersedes the position in comment of the Rule with
respect to the time zone that should be recorded.
The document states, “You should
implement time stamps with a clear understanding of what time zone reference
you use. Systems documentation should explain time zone references as well as
zone acronyms or other naming conventions.”
Question 40:
Best Answer: The FDA Warning Letters can be found on he FDA web site at http://www.fda.gov/foi/warning.htm. The letters are considered public information.
“Trust but Verify “ Ronald Re
Across the internet, there are millions of resources are available which provide information about Everything.
If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.
 |
| Data Integrity App |
Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.
- Basic Data Integrity Concepts
- ERES & Its Requirement
- CSV & Its best practices
- Mock Inspection and General Q&A
- Checklist for inspection
- Inspection Readiness
- Useful SOP’s
- Stay Regulatory Compliant.
“Stay One Step Ahead in Pharma IT Compliance”
https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity
Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.
Comments
Post a Comment