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's Registered Email® service supports 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.
In particular, preserving RPost’s Registered Email receipt associated with any document sent by email or electronically signed document 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, which can be stored by the sender in any normal email box or email archive. This electronic "receipt" is 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 Part 11, "Electronic Records; Electronic Signatures," the RPost Registered Email service simplifies compliance with at least the following requirements. In particular, if one is emailing documents to the FDA, RPost 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 Registered).
2. 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."
4. 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…"
5. 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."
To sign up for a free trial of RPost’s Registered Email Service, which includes RPost's electronic signature service, click here.
RPost does not provide legal opinions, legal guidance, or legal advice; you should not rely on the content of this article as a legal opinion, legal guidance, or as legal advice. We recommend that you consult your own counsel to evaluate your specific situation with regards to complex issues related to email and the law
Lawyers who practice in Texas stand to save a lot of time and money starting this year. As of January 1, 2014, amendments to Texas rules TRCP 21a(a)(2) and TRAP 9.5(b) now permit service of court documents by email.
The amended rules allow certain court documents, traditionally served by courier or certified first class postal mail, to be served by email. Examples of documents that can now be served electronically include discovery notices, dispute notices associated with discovery requests, meet and confer notices and requests, and emergency motions.
Lawyers who take advantage of the recent rule changes can reduce administrative time and costs when serving documents to opposing counsel and costs associated with couriers and certified first class or express mail.
Before these benefits can be realized, lawyers need to understand two critical things:
- When service by email is deemed “complete” by law
- How to prove service of documents (served by email) when opposing counsel claims non-receipt
Just as lawyers understand it’s a good practice to retain a registered mailing receipt tracking slip when serving paper documents using certified postal mail, FedEx or another method to prove service is complete, this same concept applies to emailing documents as well. It’s for this reason savvy lawyers are using RPost’s Registered Email® service to obtain automatic receipts proving successful delivery of their served electronic documents.
Be sure to download RPost’s best practice guide which covers the updated amendments and discusses what we believe constitutes “complete” service for documents served by email.
Conflicting Federal Court Rulings on NSA Phone Surveillance Ignite Debate – What to do in the Meantime?
Don’t dial that friend in Yemen just yet. On a judicial hot seat the last couple of weeks, the NSA’s maligned mass phone surveillance programs apparently have found both esteemed supporters and opponents in the country’s federal district courts.
In the past three weeks, we’ve seen two opposite rulings from US federal district courts on the constitutionality of the NSA’s mass phone surveillance programs, setting the stage for what may eventually demand US Supreme Court involvement.
On December 16, US District Court Justice Richard Leon ruled that the NSA's mass call surveillance programs are unconstitutional. Justice Leon essentially decided that because the programs could not be proven uniquely instrumental at preventing terrorist attacks, the programs are likely an unjustified breach of Fourth Amendment rights. In Justice Leon’s ruling, Klayman et al., v. Obama et al. cv-13-0851-RJL, the court first granted an injunction against the government recording of the plaintiff's telephone records but then stayed the injunction pending appeal.
However, just 11 days later, US District Court Justice William Pauley III ruled in almost the exact opposite direction – that the NSA phone surveillance programs were constitutional, because they were in fact instrumental in preventing terrorist attacks. He cites how the program, if it had been operational before 9/11, could have allowed law enforcement to know that Khalid al-Mihdhar, one of the eventual 9/11 hijackers, had made a series of phone calls from San Diego to an Al Qaeda safe house in Yemen – information that might have prevented the attack. Pauley also cites a 1979 Supreme Court decision, Smith v. Maryland, that held individuals “have no legitimate expectation of privacy” with regard to telephone numbers they dial.
In the wake of the conflicting federal rulings and what is certain to be an ongoing debate in federal courts this year, we are left to consider the future of NSA surveillance programs extending beyond phone surveillance to other media the NSA is allegedly monitoring: email, online activities and others.
Many RPost users have specifically asked us how the NSA surveillance programs have affected information privacy with regard to email communication.
When NSA whistleblower Edward Snowden’s initial revelations were made public, RPost prepared a detailed analysis as to what NSA surveillance means for email users; in terms of message privacy. We shared Snowden’s disclosure that email encryption was one of the few things that actually worked [to prevent data breaches], though “endpoint security” could be seen as a vulnerability. In a follow-up analysis, we went on to discuss how RPost’s email encryption service, unlike competitors’ offerings, is particularly resistant to data breaches and how RPost upholds data security even at the endpoints.
The debate around the constitutionality of the NSA’s surveillance programs will continue with no clear resolution on the immediate horizon.
Because a court injunction against such programs is not expected in the meantime, such surveillance programs will likely continue to operate. As such, we recommend that those concerned with information privacy adopt our “best practice for email privacy” in 2014:
Encrypt your sensitive emails with an email encryption service that secures your email not only between the endpoints but also at the endpoints.
RPost, the winner of the World Mail Award for Security, provides a simple-to-use, secure, encrypted email service as part of RMail: RPost’s all-in-one solution for high-value email and electronic document delivery. RMail services work with a user’s existing email address and can be used with Microsoft Outlook, RMail webmail, or even RMail mobile apps. New users can get started for free with a plan that allows up to 10 messages per month.
As the end of the year approaches, here at RPost we’re already looking forward to an exciting 2014. As in the past, a huge part of our company formula to advance and grow the value of our products is listening to the people who matter most – our customers!
This year’s end-user survey will once again be a short survey that will take 10-15 minutes to complete, and we truly appreciate your thoughtfulness in answering each question. Your responses will be put to good use and will help strengthen our core products, any future development efforts, and our ability to serve you.
We’ll once again be raffling off a new iPad to a lucky survey participant as a token of our appreciation. We will be sending the survey out in just a couple of weeks – so consider this a preview and a humble request to set aside some time in the near future so RPost can serve you better.
RPost today announced a major update to its RMail App for Salesforce.com. This update fills existing data privacy compliance and e-signature gaps and is unique in that:
- You can encrypt both the message body AND attachments for data privacy/compliance. Most cloud-based document sharing services send the document only secure/private - not the message body.
- You have DIRECT DELIVERY of documents to recipients, not simply a link requiring the recipient to register elsewhere to view and download.
- You receive proof of encrypted delivery for peace of mind, records and compliance in case of an audit or accusations of data breach.
- You (as an individual sender or corporate-wide) retain records of the attached document's content, with time of delivery. Without such an app, attachments are not automatically saved. Read more here.
- You receive verifiable proof of original and unalterable content (message body, attachments), time of delivery AND open tracking. Cloud delivery services do not easily show this.
- You can record signoff on message body text, AND/OR attached documents, without any document preparation or templates.
- You can pre-load templates with or without attachments, prove delivery of content, encrypt messages, and e-sign.
- You have access to detailed exportable usage and tracking data in CSV and/or XML formats.
- You get all of the above, integrated as an all-in-one app that runs within Salesforce.com.
- You can also use our Outlook add-in (with the same capabilities) for messages you prefer to send with Outlook.
Latest Blog Posts
- RPost Services Support Compliance with New FDA Guidelines on 21 CFR Part 11
- Amended Texas Rule Allows Lawyers to Serve Court Documents by Email
- Conflicting Federal Court Rulings on NSA Phone Surveillance Ignite Debate – What to do in the Meantime?
- Annual End-User Survey Coming Soon
- Upgrade Strengthens RPost's Unique Salesforce.com App Capabilities