FDA 21 CFR Part 11 Compliance and Legality in the United States
Audit-Ready Compliance
Yes. May be configured for compliance with FDA
Guidelines on 21 CFR Part 11 .
RMail Email Encryption
Relied upon in the United States since 2000.
Geography
Each of the United States.
Recommended Service
RSign® eSignatures with special settings and
RMail® email encryption with Registered Receipt™ audit-ready email proof
of compliance with FDA Guidelines on 21 CFR Part 11. RMail and RSign electronic signature services
have options to enable privacy
features.
Common Use
RSign eSignatures with encryption are used with e-prescriptions, and
within the medical device, health care, life
sciences, pharmaceutical, and biotech industries. RMail email encryption is commonly used to
meet the same privacy
needs.
Watch full video of Heather Dunn discuss
RSign
at Optimize!2020.
RSign is a saving grace, and every customer is getting their
payments a lot quicker than they would have if otherwise
mailing out of the documents.
Heather Dunn
Claims Supervisor, Mercury Insurance
Legal Aspects
RPost Services May be Configured to Support Compliance with FDA Guidelines on 21 CFR Part 11. The
RMail® encryption,
file sharing and eSignature services, RSign® services and RMail® Registered Email™ services support
compliance with 21
CFR Part 11 with regard to preserving a time-stamped audit trail and archiving the content of
documents submitted or
signed electronically for FDA purposes.
The Food and Drug Administration (FDA) has published guidance for compliance with specific
regulations in 21 CFR Part
11. This guidance is intended to describe the FDA’s current thinking regarding the scope and
application of part 11 of
Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR
Part 11). RPost Services
Support Compliance with FDA Guidelines on 21 CFR Part 11.
Preserving the RMail Registered Receipt™ and RSign® signature certificate associated with any
document sent by email or
sent for electronic signature with RMail and RSign automatically preserves a time-stamped audit
trail and original
content of the document (and email message body text content as well as electronic signature).
This is preserved in the
form of a Registered Receipt™ email record or RSign signature certificate, which can be stored
by the sender in any
normal email box, email archive, or document archive (or with RMail or RSign services online
depending on the service
options and features). These electronic “receipts” are self-contained, can be independently
authenticated, and can
re-construct an authenticated time-stamped original content in a human readable and standard
electronic format.
One can then optionally elect to preserve the original message and documents as that information
is preserved with the
transmission audit trail, within the electronic receipt itself.
With regards to the FDA guidance on 21 CFR Part 11, “Electronic Records; Electronic Signatures,”
the RMail and RSign
services simplify compliance with at least the following requirements. If one is emailing
documents to the FDA, RMail
and RSign can automatically add authenticated electronic signatures and provide a record
returned to the sender that
complies with Part 11; the process is as easy as attaching a DOC or PDF to an email and sending
(sending via RMail or
RSign).
Excerpts of important elements of FDA guidance on 21 CFR Part 11 as it relates to RSign and
RMail follows:
-
Audit Trail: “…computer-generated, time-stamped audit trails (§ 11.10 (e), (k)(2) and any
corresponding requirement
in §11.30). Persons must still comply with all applicable predicate rule requirements
related to documentation of, for
example, date (e.g., § 58.130(e)), time, or sequencing of events, as well as any
requirements for ensuring that changes
to records do not obscure previous entries.”
- Copies of Records: “…generating copies of records (§ 11.10 (b) and any corresponding
requirement in §11.30)… We
recommend that you supply copies of electronic records by: Producing copies of records held
in common portable formats
when records are maintained in these formats… In each case, we recommend that the copying
process used produces copies
that preserve the content and meaning of the record… You should allow inspection, review,
and copying of records in a
human readable form…”
- Record Retention: “…for the protection of records to enable their accurate and ready
retrieval throughout the records
retention period (§ 11.10 (c) and any corresponding requirement in §11.30). Persons must
still comply with all
applicable predicate rule requirements for record retention and availability (e.g., §§
211.180(c),(d), 108.25(g), and
108.35(h)). …any copies of the required records should preserve their content and meaning.
As long as predicate rule
requirements are fully satisfied and the content and meaning of the records are preserved
and archived, you can delete
the electronic version of the records. In addition, paper and electronic record and
signature components can co-exist
(i.e., a hybrid8 situation) as long as predicate rule requirements are met and the content
and meaning of those records
are preserved.”
Laws Referenced
The Food and Drug Administration (FDA) has published guidance for
compliance with specific regulations in 21 CFR Part
11.
Disclaimer: Neither RPost nor its affiliates provide legal opinions. The information on RPost
and
its affiliates and
products websites is for general information purposes only and is not intended to serve as legal
advice or to provide
any legal opinions. Laws and regulations change from time to time and neither RPost nor its
affiliates guarantee that
all of the information on RPost and its affiliates’ websites are current, correct, or with
sufficient detail for the
purpose of each reader. You should consult your legal counsel for specific jurisdictional
details
and other issues.
Tradenames are owned by the named company. Service benefit is summary, not intended to be a case
study. RPost
technology is patented. RMail, RSign, and RPost are trademarks owned by RPost.