Form: 21 CFR 11.100(c) Electronic Signature Certification Letter

This is a ready-to-use draft of the certification letter required by 21 CFR 11.100(c) before an organization first relies on electronic signatures as the legally binding equivalent of handwritten signatures. It is a one-time, organization-wide filing, not a per-system submission, and it is easy to lose track of because it is filed once and then rarely touched again. Replace every <<FILL: ...>> placeholder with your own specifics. A worked filled specimen follows. Verify the current submission route and required elements against FDA’s published guidance before filing; this is educational structure, not legal advice.

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1. Purpose

Before or at the time an organization first uses electronic signatures under 21 CFR Part 11, it must certify to FDA that it intends those electronic signatures to be the legally binding equivalent of traditional handwritten signatures. This is a single, organization-wide certification, not something filed again for every new system, though many organizations keep a log of which systems rely on it (section 4) so the connection is documented.

2. Required elements (11.100(c))

The certification must:

1. Be submitted in paper or electronic form, at the organization’s choice; it is not restricted to a mailed paper letter.
2. Carry a traditional handwritten signature of the person certifying on behalf of the organization, per 11.100(c)(1), even when submitted electronically.
3. State clearly that the organization intends that all electronic signatures executed by its employees, agents, or representatives, located anywhere in the world, are the legally binding equivalent of traditional handwritten signatures.
4. Additional certification of a specific electronic signature, on request, must be provided to FDA within a specified time under 11.100(c)(2).

3. Letter draft

<<FILL: Organization letterhead / name and address>>

<<FILL: Date>>

Food and Drug Administration <<FILL: current mailing address or submission channel per FDA's published Letters of Non-Repudiation Agreement page; electronic submitters use the Electronic Submissions Gateway>>

Re: Certification of Intent to Use Electronic Signatures Under 21 CFR 11.100(c)

To Whom It May Concern:

Pursuant to 21 CFR 11.100(c), <<FILL: Organization legal name>> hereby certifies that all electronic signatures executed by its employees, agents, and representatives, whether located within the United States or elsewhere, are intended to be the legally binding equivalent of traditional handwritten signatures.

This certification applies organization-wide and is not limited to a specific computerized system, facility, or business unit.

Should FDA request additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer’s handwritten signature, <<FILL: Organization legal name>> will provide such certification within the timeframe specified in the request, per 21 CFR 11.100(c)(2).

Sincerely,

<<FILL: handwritten signature>> <<FILL: printed name>> <<FILL: title>> <<FILL: Organization legal name>>

4. Systems relying on this certification (internal tracking, not part of the FDA filing)

5. Acceptance criteria

• The letter states the certification in the exact terms required by 11.100(c): binding equivalence, organization-wide, regardless of signer location.
• The letter carries a traditional handwritten signature from an individual authorized to bind the organization, even if the letter itself is submitted electronically.
• The current submission route has been confirmed against FDA’s published guidance immediately before filing, since the route has changed over time.
• A copy of the filed letter, with proof of submission, is retained with the organization’s quality records and is retrievable within minutes if an inspector asks to see it.
• The internal tracking table (section 4) is kept current as new systems adopt electronic signatures, even though this table is not part of the filing itself.

6. References

21 CFR 11.100(c), certification of intent to use electronic signatures as legally binding. FDA’s published Letters of Non-Repudiation Agreement submission page (current route); electronic submitters use the Electronic Submissions Gateway.

Confirm the current submission address, portal, and any procedural updates against the FDA source immediately before filing; this route has changed at least once since the original 1997 rule and may change again.

7. Sign-off (internal approval before filing)

Filled specimen

Illustrative example for a mid-size biologics manufacturer adopting electronic signatures for the first time as part of a LIMS go-live.

Nothing about this specimen is complicated; the value of the form is that it exists, is filed before go-live rather than as an afterthought discovered during an inspection, and stays retrievable years later when nobody on the current team remembers it was ever done.

Common inspection findings this form prevents

• A company using electronic signatures for years with no certification letter on file at all.
• A certification letter that exists but cannot be located quickly because it was filed once, informally, and never logged.
• A letter that certifies a specific system rather than the organization as a whole, leaving new systems in an ambiguous position.
• A submission sent to an outdated address because the filing route was never reconfirmed against current FDA guidance.

How to adapt this form

1. Confirm the current submission route on FDA’s site immediately before filing; do not reuse an address from an old template without checking.
2. Have the letter reviewed by whoever in the organization holds authority to make regulatory certifications, not just by IT or CSV.
3. File the internal tracking table (section 4) alongside the letter in the quality records so future validation teams know the certification already exists and do not re-file it unnecessarily.
4. If the organization operates as multiple distinct legal entities, confirm whether one certification covers all of them or whether each entity needs its own.