Question 01:
If you use Electronic Signatures, do you have to comply
with Electronic Record Requirements?
Best Answer: Use of Electronic Signatures implies
that your system is an Electronic Record system and, therefore, must be in
compliance with all provisions of 21 CFR Part 11.
Question 02:
Are electronic signatures always required on the creation
of electronic records?
Best Answer: The ‘Predicate Rules’ (GxP)
regulations determine what records must be signed, not Part 11. Not all
e-records need to be signed.
Check your predicate rules for what records must be signed, when and by whom.
Check your predicate rules for what records must be signed, when and by whom.
Question 03:
Does Part 11 apply to instruments themselves that are not
connected to computers but that have microprocessors within?
Best Answer: If such a system does not generate
electronic records according to the definition of e-records in Part 11 (data
starting its life written to durable media), and/or these e-records are not
subject to the GxP regulations, then Part 11 does not apply.
Best Answer: The question is really not that much
for the storage media, it’s more whether the operator can manipulate the data
before they are printed.
The real problem is that most of this equipment does not have functions required by part 11.
I keep electronic records but have signatures on paper
(hybrid systems). Is there a deadline for converting to electronic signatures?
Question 04:
Does Part 11 apply to electronic systems that can print
records but do not have a durable storage media (i.e. flash memory or memory
buffer, etc.)?
The real problem is that most of this equipment does not have functions required by part 11.
Question 05:
Best Answer: No. There is no deadline for
converting to electronic signatures. Having handwritten signatures on paper is
acceptable if signature are linked to electronic records so signers cannot
repudiate records.
Question 06:
How long must data
concerning electronic signatures be kept?
What
data? Best Answer: The signed data may no longer be separated from the signature. Signature
and signed data must be kept for an equal period of time.
The
retention period to be specified must be defined according to the underlying
requirements, such as GxP requirements (other requirements may also be
relevant: commercial law, liability law etc.).
Data concerning the undersigned
has to be kept at least as long as the signed data (data concerning the
undersigned is in fact metadata of the signed data).
In
any case, the user data should be kept as long as the system is operated and as
long as the signed data must be kept.
Can a single restricted login suffice as an electronic
signature?
Question 07:
Best Answer: No. The operator has to indicate
intent when signing something, and he has to re-enter the user ID/password
(shows awareness that he is executing a signature) and give the meaning for the
e-sig.
To support this, Part 11 §11.50,
states that signed e-records shall contain information associated with the
signing that indicates the printed name of the signer, the date/time, and the
meaning, and that these items shall be included in any human readable form of
the record.
Best Answer: The predicate rules mandate when a
regulated document needs to be signed.
Best Answer: No. The required one-time e-sig
certification is for an organization as a whole. Its intent is to certify that
a company recognizes that its e-signatures are equivalent to their hand-written
signatures.
Best Answer: Part 11 Sec. 11.70 states that
electronic signatures and handwritten signatures executed to electronic records
must be linked (i.e. verifiably bound) to their respective records to ensure
that signatures could not be excised, copied, or otherwise transferred to
falsify another electronic record.
Question 08:
When are e-signatures required?
Question 09:
Should a company individually certify that every
associate’s electronic signature is legally binding?
Question 10:
What do you mean by linking e-records to e-signatures?
The agency does not, however, intend
to mandate use of any particular ‘linking’ technology. FDA recognizes that,
because it is relatively easy to copy an electronic signature to another
electronic record and thus compromise or falsify that record, a
technology-based link is necessary.
The agency does not believe that
procedural or administrative controls alone are sufficient to ensure that
objective because such controls could be more easily circumvented than a straightforward
technology based approach.
“Trust but Verify “ Ronald Re
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