Summary
- The problem
- When reviewed results are copied into a certificate template, each value is another transcription to check. A result still under review is easy to fill with an assumption, and a corrected certificate can replace what a customer already received.
- Seal’s approach
- The certificate is prepared from reviewed results, the applicable specification and a versioned template. Each value keeps its method, specification and reportable-value rule, and a missing result stays visible.
- What changes
- A pending result keeps the certificate in draft. The PDF and data export use the same selected results, and issue, delivery and amendment keep their own history.
- Where to start
- One certificate, its source results and the rules used to issue it. Book a demo.
Only reviewed results belong on the certificate.
A certificate restates results that already exist in reviewed records. Copying them into a template adds a transcription to check at every value, and a result still under review invites an assumed entry. In this example, three reportable results are available for batch DP-086. The residual-solvent result is still under review, so the certificate stays a draft.
DP-086 / certificate of analysis
DraftResidual solvent
RES-086-S- Method
- AM-031 / v02
- Reportable value
- Not available
- Review
- Open
No approved reportable value is available in the selected records. The draft must not substitute zero, a previous batch’s result or an assumed conforming statement.
What follows
Complete the source result review and refresh the draft before certificate issue review.
Run the work in Seal.
Resolve the applicable source set.
Select the batch, product, market or customer context, specification, reviewed results and certificate template.
Prepare the certificate.
Apply the agreed statement and formatting rules. Surface missing results and inconsistent references before routing the draft.
Review, issue and retain.
Record the authorised issue decision and delivered version. Link any amendment to the original certificate and its recipients.
Three reviewed results are available. The residual-solvent result is still pending review, so I have not filled it with an assumed value or treated the draft as ready to issue.
DP-086 / certificate review
DraftComplete the missing result review, then reconcile the certificate’s source set, statements and issue requirements.
QC reviewer
Complete the residual-solvent review and retain the reportable result.
Certificate reviewer
Check assay units and the selected source version.
Certificate reviewer
Verify the water formatting rule before issue.
From reviewed results to the delivered certificate.
Why teams choose Seal for certificates of analysis
Certificates are traditionally prepared by copying reviewed results from a LIMS into a document template, then checked value by value before signature. Seal prepares the certificate from the reviewed results and the applicable specification themselves, with each value keeping its method and reportable-value rule.
A pending result keeps the certificate in draft, and an amendment is issued as a new version while the first issue stays on record. Template changes are versioned and approved like any other configuration.
An amendment keeps the first issue.
Correct the certificate without erasing what was previously supplied.
Retain the original document, corrected version, reason, approval and distribution history. Make supersession clear and identify which recipients need the amended certificate.
The document and data export agree.
Use the same selected results and reportable-value rules for the PDF and machine-readable handoff.
Check units, rounding, qualitative statements and missing-value handling in each output. A regenerated preview is not automatically the issued certificate or a new release decision.
The format follows the intended recipient.
Configure product, customer and language-specific templates without separating the certificate from its data.
Review which tests and statements belong in the output, the applicable specification, reportable units and any required translation. Retain the chosen template version. A different presentation must not silently change the result or the criterion against which it was reviewed.
Issue and delivery have their own history.
Keep the authorised issue decision, signature meaning and exact delivered version with the certificate.
Record recipients and the agreed distribution route, whether an existing portal, an API or a document handoff. Scope access and delivery confirmation. If source results change, assess the issued certificate and any amendment or recipient notification rather than overwriting the original output.
Connected to the surrounding work.
Keep specialised systems where they belong. Agree the source of each record, the permitted actions and the reconciliation at each handoff.
Explore integrationsAQuestions and answers
Can we use customer-specific formats?
Configure the template, language and required statements for the applicable product and customer. Review that context as well as the result values.
Can the certificate use an external LIMS?
Scope access to reviewed results, versions, units and the approval state. Preserve the source-system reference and define how corrections are reconciled.
Does generating a CoA release the batch?
No. Certificate preparation, certificate issue and batch disposition are distinct actions with the approvals your quality system requires.