21 CFR 211.165
Testing and release
Release rests on laboratory results that meet specification, recorded on the sample and signed in the usage decision.
CFast · Certificate of Analysis
Certificate of analysis software that cannot issue a certificate the results do not support.
CFast turns an approved sample into a certificate of analysis: the effective specification, the reviewed results, the batch or lot, the conclusion and the people who signed, on a controlled template and in a numbered copy. It is part of CORPEX LIMS, so the certificate always reflects the live record.
- Stage 1Specification
- Stage 2Results
- Stage 3Review
- Stage 4Technical approval
- Stage 5Usage decision
- Stage 6Certificate issued
The CoA workflow in CORPEX LIMS. Results are reviewed one by one, the reviewer signs, and the usage decision releases the sample.
- 6
- Workflow stepsSpecification to certificate
- 3
- Copy typesControlled, information, draft
- 4
- Template statesDraft, review, approved, retired
- 1
- RecordSame sample as the laboratory
Specification to result
The certificate starts from the specification, not a template
Tests, limits and criteria come from the specification version that was effective when the sample was registered. A specification is versioned and e-signed, one version is effective per code, and the sample carries that version with it. Each result is evaluated against its criterion, so conform or not conform is stated by the system, not typed.
- Specification lifecycle: draft, pending, approved, effective, superseded.
- Approval by a different person than the author, with a signature.
- Mandatory and optional tests, so the conclusion reflects the required ones.
- See CORPEX LIMS for the sample, ELN and instrument side.
Gate
The certificate refuses to be issued early
The certificate view checks the sample before it offers a download. A test with no result, a result nobody has reviewed, an unapproved template or a missing usage decision each stop it, with the reason on screen. The download enforces the same rule as the button, so a direct link does not get around it.
- Every test has a result and every result is reviewed.
- A reviewer signs the technical approval; an open OOS on the same product and batch blocks it.
- The usage decision is signed with the password and completes the sample as approved.
- A rejected or rework decision means no certificate can be issued.
Copies and versions
Every printed certificate is accounted for
A released certificate is issued as a controlled copy and booked in the print register with a copy number. Others get an information copy. A draft copy is available only where your policy allows printing before the usage decision. A retest produces a new version, with carried-forward results marked.
- Numbered controlled copies; a reprint needs a reason.
- Reviewer, approver and usage decision are printed with name, date and time.
- A combined certificate across the lab sub-samples of a split sample.
- The registry lists control number, item, batch, conclusion, usage decision and approval date.
Content
Batch, Result and Signature in One Document
The certificate is built from the record, so each field has a source you can trace.
Batch and item
Item, QC number, batch or lot, section, received date, sample size, manufacturing and expiry date, and the specification number where your market wants it.
Results and conclusion
Test, specification, result and outcome per row, then an overall conclusion band that shows not conform as soon as one result fails.
People and decision
Reviewed by, approved by and the usage decision with who made it and when, so the reader can tell who made the decision.
Controls
Where the Controls Sit
These checks are in the software, not in an SOP that someone has to remember.
Controlled templates
A template moves from draft to review to approved with a signature. The approver must differ from the author and the reviewer, and signs with a password.
Letterhead per template
On single-sample certificates, name, logo, subtitle and address can differ by template; a template without them falls back to the site profile. A combined certificate for split sub-samples does not use the template letterhead.
Segregation of duties
Reviewing and approving a sample follow the same rule: you do not sign your own work.
Batch on hold
An open OOS on the same product and batch blocks technical approval of the sample.
Audit trail
Approvals, usage decisions and print bookings are written to a hash-chained audit trail.
Signatures with date and time
Signatures print with date and time of day, not date alone.
Compliance
Which Rule Each Control Answers
Each card names the control in the software that answers it.
ICH Q7 §11.4
Certificates of analysis
Certificates carry batch, results against limits, dates and the identity of the approver. The finished-product equivalents are 21 CFR 211.194 and EU GMP Chapter 6.
21 CFR 11.50
Signature manifestations
Printed name, date, time and the meaning of each signature on the certificate.
EU GMP Annex 11
Computerised systems
Role-based rights, segregation of duties and an audit trail on the records the certificate comes from.
This page describes software controls. Your quality unit decides how they meet each rule.
FAQ
Questions We Get From QA Teams
Short answers, based on what the software does today.
What is CFast?
CFast is the certificate of analysis capability of CORPEX LIMS. It builds the certificate from the sample record that already holds the batch, the specification and the reviewed results, so nothing is retyped. It is not a separate database; it runs on the same records as the laboratory.
When can a certificate be issued?
Only when every test on the sample has a result and every result has been reviewed. If the template is not approved, or the usage decision has not been recorded and is not favourable, the certificate is refused too. The screen shows the reason, for example that a test has no result entered.
What stops a certificate being issued while an OOS is open?
An open OOS on the same product and batch blocks technical approval, so no certificate can be issued for that sample until the investigation is dispositioned.
Can the same certificate be printed twice?
The person who issues certificates gets a controlled copy, which is booked in a print register with a copy number. A reprint needs a reason and is marked as a numbered reprint. Anyone else who can see the sample downloads an information copy, watermarked not for release, and a draft copy is available only where your policy allows printing before the usage decision.
What happens to the certificate after a retest?
The certificate issued after a retest is a new version of the first one. The version is printed on its face, and results that were not re-measured are carried forward and marked with an asterisk and a legend.
Can each customer have their own certificate layout?
A certificate template controls the letterhead, header and footer text, which tests the customer sees, how below-limit results read and whether the specification number is printed. Templates are controlled documents: drafted, reviewed and approved with a signature, and the approver must differ from the author and the reviewer. Only an approved template may issue a single-sample certificate.
See a Sample Become a Certificate
Book a demo and we will take one sample from specification to a signed, numbered certificate with you.
Request a Demo