Certificates and electronic signatures — CoC, CoA and 21 CFR Part 11
Issue a numbered, frozen Certificate of Conformance or Analysis from the lots actually despatched and the inspections recorded against them — and, in 21 CFR Part 11 mode, sign approvals, document releases, NCR closures and certificates with an e-mail + PIN signature that is bound to the record.
Section 01
Certificates of Conformance and Analysis
1 minute
A customer in aerospace, rail, medical or food does not just want the goods — they want the paper that says the goods are right. A Certificate of Conformance (CoC) states that what was delivered conforms to the drawing, the specification and the order, names the lots and points at the inspection records that prove it (AS9100 §8.6 asks for exactly that objective evidence). A Certificate of Analysis (CoA) goes further: for every lot it lists the tests performed, the acceptance limits, the measured results and who measured them — the shape ICH Q7 §11.4 and EU GMP prescribe for a batch.
Brytebuild builds both from what actually happened, never from a typed form: the lots come from the delivery's packing, the results from the inspections recorded against those lots. Issuing freezes the document — numbered, fingerprinted, and in Part 11 mode electronically signed. Issue again and the old certificate is superseded, never edited.
Section 02
Issuing a certificate
2 minutes
Open the delivery order. Under the item list a Certificates card offers Certificate of Conformance and Certificate of Analysis. For a CoC you may type your own conformity statement first (leave it blank for the standard wording); press again to issue. In Part 11 mode the electronic-signature prompt appears — your e-mail and signing PIN — and the certificate is signed as Issued. The row then shows the number (COC-2026-0001, COA-2026-0001), who issued it and when, the signature, and a PDF button. Everyone who can see inspection plans sees the certificates and their PDFs; issuing is for the Quality role (the “change inspection plans” capability) and the company owner — the authorised quality function signs the certificate, as AS9100 expects.
A certificate covers despatched lots, so it refuses until at least one packing is collected for the delivery — you cannot certify goods that have not physically been picked. Issue after despatch, or once the last packing is collected.
Section 03
What is printed
2 minutes
| Block | CoC | CoA |
|---|---|---|
| Header | Your company and address; certificate number; issue date; customer and ship-to; the delivery ref and date; the sales order and the customer's order number. | Same. |
| Items | Per product: part number, description, revision, quantity despatched, lot / batch numbers (and a count of serials). | Same. |
| Statement | The conformity statement (yours or the standard one) and the objective evidence: the inspection report numbers for the despatched lots. | — |
| Per lot | — | Each lot's inspections — report number, plan, date, inspector, overall result — and every characteristic: requirement / acceptance limits, unit, measured result, pass/fail, method or gauge. Lot expiry where the lot has one; release date = issue date. A lot with no recorded inspection says so rather than printing nothing. |
| Signature | Part 11 mode: Electronically signed by Name on date time UTC — Issued, the signature ID and the record hash. Otherwise: Authorised by Name on date. | Same. |
Which inspections count for a lot: those recorded against the lot's container, and if there are none, those recorded against the works order that made it. Record final inspections on the lot or the works order and the CoA fills itself.
Section 04
21 CFR Part 11 mode
3 minutes
FDA 21 CFR Part 11 is the rule that lets an electronic record and an electronic signature stand in for paper and ink. Brytebuild implements the parts that a piece of software can implement, and says plainly which parts remain your procedures. With the switch on, four transitions become signed acts:
| Action | Meaning recorded | Where you see it |
|---|---|---|
| An approval decision — approve or reject any request routed by an approval workflow (documents, ECOs, NCRs, concessions, purchase and sales orders, lifecycle changes) | Approved / Rejected | The request's Decision history. |
| Publishing a controlled document revision | Released | The revision's signature chips (marked e-signed). |
| Closing an NCR | Closed | The NCR's Root cause & actions section. |
| Issuing a CoC or CoA | Issued | The Certificates card and the PDF itself. |
Turning the switch on does not make a company "Part 11 compliant" on its own. 11.100(c) asks you to send the FDA a one-time letter stating that your electronic signatures are the legally binding equivalent of handwritten ones; 11.10(a) and (i) ask for system validation and for training records; 11.300(b) asks for a password / PIN revision procedure. Those are yours to document. What the software guarantees is below.
Section 05
Signing
2 minutes
Each person sets their own signing PIN under Settings → Compliance (also on their profile page): six characters or more, stored hashed like a password, changeable only from their own session. When a gated action is taken, a prompt shows what is about to be signed and asks for the e-mail (pre-filled, the identification) and the PIN — the two distinct components 11.200(a) requires — plus an optional comment. Someone without a PIN can sign with their account password until they set one. Every signing asks for both components; we do not use the regulation's "one component on later signings" relaxation.
A wrong PIN is refused with The e-mail or signing PIN did not match. The attempt has been recorded. — the attempt is written to the audit log and the action does not happen. Five failures in fifteen minutes lock signing for that person for fifteen minutes (11.300(d)). A correct signature records the printed name, the date and time in UTC, the meaning, the signer, the IP address and a SHA-256 of the record's content at that moment.
Electronically signed by Adam Reyes on 12 Sep 2026 18:14:19 UTC — Closed is the manifestation 11.50 requires on every human-readable form of the record. If the record is later changed, the line gains record changed since signing: the hash no longer matches, so the signature no longer vouches for what you are looking at (11.70).
Section 06
The rules the system enforces
1 minute
| Rule | Regulation |
|---|---|
| Two identification components at the moment of signing, every time | 11.200(a)(1) |
| Printed name, date and time, and meaning on the record and on every printout | 11.50(a), (b) |
| Signature bound to the record by a content hash; a moved or altered record no longer matches | 11.70 |
| Failed attempts recorded; five in fifteen minutes lock signing | 11.300(d) |
| Signatures and certificates are create-only; re-issue supersedes, nothing is edited or deleted through the application | 11.10(c), (e) |
| Every mutation is already in the audit log with who, when and what changed | 11.10(e) |
| Human-readable copies: the PDF, and the record pages themselves | 11.10(b) |
Biometric signatures; password-ageing and complexity policies (a procedure, not a feature); signing the raw inspection capture as it is typed (the certificate that reports it is signed instead); customer-specific certificate templates; sending certificates by e-mail automatically.