lims-coa

CoA Generator

Generate. Sign. Ship.

4.532 becomes 4.352. The product was fine—the certificate was wrong. Generate CoAs directly from validated LIMS data. No retyping. No transcription errors.

CoA Generator

The phone call came at 4 PM on a Friday.

"Your Certificate of Analysis doesn't match our incoming inspection results." The customer's QC manager read the numbers: Assay showed 98.7% on their CoA, but the incoming test showed 98.2%. Had the product degraded in transit? Was there a stability issue? They'd put the shipment on hold pending investigation.

Three hours later, your QA team found the answer. The LIMS showed 98.2%. Someone had typed 98.7% into the Word template. A transposition error—the kind that happens when you're copying fifteen values from one screen to another while someone asks about the next batch. The product was fine. The certificate was wrong.

Now you're issuing a corrected CoA, documenting the error, explaining to a customer why your quality documentation can't be trusted at face value, and wondering how many other certificates went out with numbers nobody double-checked closely enough.

CoA Generation Flow

The 4.532 that became 4.352

It happens like this: QC approves the final test results in the LIMS. Someone exports to Excel—or prints a report and works from paper. Someone else opens the Word template, finds the right cells, and starts typing. Assay: 99.2%. Purity: 98.7%. Moisture: 0.43%. Fifteen values, manually transcribed.

The reviewer pulls up the LIMS and checks each value against the template. Everything matches—except one. The original said 4.532%. The CoA says 4.352%. Nobody noticed because they were checking quickly, because they'd done this a hundred times, because the digits looked close enough.

Before and After

Now multiply this across every batch, every product, every day. Transcription errors aren't rare. They're inevitable in a manual process. Industry data suggests 1-3% of manually transcribed values contain errors. If your CoA has fifteen test results, the math is uncomfortable. The only question is whether you catch them before the CoA ships or after a customer calls asking why your certificate doesn't match their incoming inspection.

Why does anyone type this data?

Every piece of data on that CoA already exists in your systems. The test results are in the LIMS. The batch information is in the MES. The specifications are defined. The release decision has been made. The data is digital, validated, approved—and then someone prints it out and types it into a Word template.

This workflow exists because systems don't talk to each other. The LIMS doesn't generate formatted documents. The document template doesn't connect to the LIMS. So humans bridge the gap, acting as manual integrations between systems that should have been connected from the start.

Generation, not assembly

Seal generates CoAs directly from approved test results. When QC completes testing and results are approved, the CoA data is ready. Click "Generate," select the template, and the document assembles itself from the database. The test result that shows 4.532% in the LIMS shows 4.532% on the CoA because it's the same data—not a copy, not a transcription, the actual value pulled in real time.

The document you generate is guaranteed to match the underlying data because it is the underlying data, formatted for distribution. If someone asks "does the CoA match the LIMS data?", the answer is definitionally yes. There's nothing to reconcile. The question stops making sense.

One format doesn't fit all

Different products need different CoAs. A sterile injectable requires different information than an oral solid dose. An API certificate looks different from a finished drug product certificate. Major customers have their own format requirements—one wants results in a table, another wants them listed, a third wants their logo on the document.

Template Flexibility

Seal supports unlimited templates. Define what data appears, how it's formatted, where signatures go. When you generate a CoA, select the appropriate template and the system handles the rest. Customer A gets their format. Customer B gets theirs. The EU market gets German-language certificates. Japan gets Japanese. Everyone gets accurate data because it all comes from the same source.

Template changes go through version control. When you update a format, historical CoAs regenerate using the template version that was active when they were originally created. The certificate from 2022 looks exactly like it did in 2022, even if today's template has changed.

From hours to seconds

The traditional process—export, copy, review, print, sign, scan, save—takes hours. Multiple people involved, multiple handoffs, multiple opportunities for delay. When a shipment is waiting and the CoA isn't ready, the pressure builds. Mistakes happen when people rush. The truck is idling at the dock while someone hunts for a signature.

Seal compresses this to seconds. Results approved. Click generate. Review on screen. Apply electronic signature. Done. The entire process from "generate" to "signed PDF" takes under a minute. The product and the CoA are ready simultaneously—no shipment waiting on paperwork.

For concurrent release workflows—cell therapies, radiopharmaceuticals, anything with a short shelf life—the CoA builds incrementally as results approve. When the final test passes, the certificate is already complete. Sign and ship.

Historical access without archaeology

When a customer requests a CoA from two years ago, what happens? Someone searches the file server. They navigate through folder hierarchies hoping the naming convention was followed. They find three files with similar names and try to determine which is the final signed version. "CoA_Batch2847_v2_FINAL_signed.pdf" or "CoA_Batch2847_v3_FINAL_FINAL.pdf"? They email it and hope it's correct.

In Seal, every CoA is linked to its batch record. Click the batch, click the CoA, download. The system knows exactly which document was generated, when, by whom, and with what data. Regenerate on demand if needed—the historical data is preserved, and the document rebuilds from the original values using the original template version.

When auditors ask for the CoA that shipped with a specific batch, you show them in seconds. When customers ask for replacement certificates, you send them in minutes. The archaeology expedition through folder structures disappears.

Distribution without email chains

Stop emailing PDFs. Give customers secure portal access to download their own certificates. They log in, see their batches, download what they need. Every access is logged. When someone calls asking "where's my CoA?", you either see that they already downloaded it or send them a link to get it themselves. No more "let me check and get back to you."

For customers who want to automate, API access delivers CoA data directly into their systems. They don't need PDFs—they need the data in a format their incoming QC system can ingest. Seal provides both: human-readable certificates and machine-readable data from the same source.

Works with what you have

Already running a LIMS? Seal connects to LabWare, STARLIMS, Benchling, and custom solutions. Pull approved results directly from your existing systems. Your analysts keep working where they're comfortable. CoA generation happens automatically from validated data—no double entry, no export-import, no reconciliation.

For organizations running multiple LIMS across sites, Seal normalizes data from different sources into consistent certificate formats. One template definition, multiple data sources, unified output quality. The customer sees the same professional certificate whether the testing happened in Boston or Berlin.

Capabilities

01One-Click Generation
Generate CoAs directly from approved test results. No copying, no transcription, no manual assembly. Data equals document.
02Template Management
Multiple templates for different products, customers, and markets. Version-controlled with full change history.
03Electronic Signatures
Part 11 compliant signatures directly on the generated document. Ready for distribution immediately after signing.
04Historical Regeneration
Regenerate any historical CoA on demand using original data and template version. Complete audit trail.
05Batch Release Integration
CoA generation is part of the release workflow. Product released and CoA ready simultaneously.
06Multi-Language Support
Generate CoAs in multiple languages from the same data. English for US, German for EU, Japanese for Japan.
07LIMS Integration
Connect to LabWare, STARLIMS, Benchling, or custom LIMS. Pull approved results automatically. No data re-entry.
08Customer Portal
Give customers secure access to download their own CoAs. Every access logged. No more emailing PDFs.
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One-Click Generation
One-Click Generation

Entities

Entity
Description
Kind
Certificate of Analysis
Generated document containing test results and release information.
type
CoA-B2847
Certificate for Batch 2847, generated March 2024.
instance
Batch CoA
Standard product release certificate.
template
CoA Template
Configurable template defining CoA format and content.
type
Customer CoA
Customer-specific format template.
template
Test Result
Approved result pulled into the CoA.
type
Batch
Manufacturing batch linked to the CoA.
type
Specification
Pass/fail criteria shown on the CoA.
type
E-Signature
Part 11 compliant electronic signature.
type

FAQ

Yes. Templates are fully configurable—you define what data appears, how it's formatted, and where signatures go. Different products can use different templates. Use our template builder or import your existing Word template as a starting point.