Stop Manually Reviewing Certificates of Analysis
Longi Engineering’s AI-powered COA automation reads, extracts, validates, and reports lab data in minutes eliminating hours of manual document review for biotech and pharma quality teams.
70%
review time
45 min
processing time
90%+
accuracy
25+
supported
What Does COA Automation Do?
COA automation leverages artificial intelligence, document AI, and machine learning to automatically process Certificates of Analysis (COAs). It reads unstructured documents such as PDFs, extracts all relevant quality and compliance data, validates results against predefined specifications, and transforms them into structured, usable formats for downstream systems.
By eliminating manual data entry and reducing human handling of routine documents, it ensures faster, more accurate, and audit-ready data processing. Human review is only required for exceptions or out-of-specification results that need escalation.
Key capabilities of a COA automation solution include:
- Intelligent extraction of product name, lot and batch number, test parameters, and results from unstructured PDFs
- Automatic comparison of extracted results against approved specifications and acceptance criteria
- Routing of out-of-specification results for immediate human review and escalation
- Integration with ERP, LIMS, and quality management systems for seamless data flow
- Digital filing, indexing, and search of all COA records for instant retrieval during audits.
Manual COA review is costing your team time, money, and compliance risk
Biotech and pharma quality teams spend thousands of hours annually on a process that AI can handle in minutes. Here’s the reality of manual COA management.
30–90 Minutes Per Document
Staff manually opens each COA PDF, reviews test parameters, compares them against specifications, and re-enters results into spreadsheets or ERP systems one document at a time, daily.
High Risk of Human Error
Copy-paste errors in critical safety and efficacy data can cause compliance failures, batch rejections, regulatory citations, and costly product recalls, risking both safety and business outcomes.
Documents Scattered Everywhere
COAs scattered across email inboxes, shared drives, and paper files turn pre-audit preparation into a multi-day scramble and slow regulatory reporting, delaying compliance and operational efficiency.
No Path to Scale
As your product portfolio and supplier network grow, COA volume grows with it. Manual processes don't scale organizations end up hiring more people just to perform additional data oversight.
Audit Preparation Takes Days
Preparing COA records for audits and quality reviews can take weeks when done manually. An automated system drastically reduces the time required, making audit preparation faster and more efficient.
$150K+ in Hidden Labor Costs
Mid-size pharma and biotech organizations typically spend over $250,000 annually in fully loaded labor costs for manual COA processing—budget that belongs in research, not data validation.
See It in Action
Watch Our AI Process a COA in Minutes
See exactly how our AI reads a Certificate of Analysis, extracts all critical data fields, validates against your specifications, and delivers a clean structured report without a human in the loop.
01
Upload any COA PDF, scanned image, or email attachment in any format from any lab or supplier
02
AI reads every field: product name, lot number, test parameters, and results automatically.
03
Validated, structured data is ready for your ERP, LIMS, or compliance system in minutes, not hours
How It Works
From document to decision-ready data in 4 steps
A fully automated COA workflow that replaces manual review with intelligent AI processing no template setup, no configuration headaches.
Receive COA
COAs arrive via email, supplier portal, upload, or API integration. Any format, any lab, any supplier — accepted automatically.
AI Extracts Data
Our AI reads the document and identifies all key fields — product name, lot number, test parameters, results, and specifications — with 90%+ accuracy.
Validate & Flag
Results are cross-checked against your specifications. Out-of-spec values are instantly flagged for human review — everything else passes automatically.
Report & File
Structured data flows into your ERP, LIMS, or QMS. Batch reports and compliance documentation are generated and filed automatically.
Capabilities
Everything your team needs to automate the entire COA workflow
Purpose-built for the precision and compliance demands of pharma and biotech not adapted from a generic document processing tool.
Intelligent Document Reading
Processes COAs from PDFs, scanned images, emails, and spreadsheets. Automatically handles any format or layout from any supplier, with no template setup required, ensuring fast, accurate data capture.
90%+ Extraction Accuracy
Advanced AI models trained specifically on laboratory and quality documents deliver highly accurate data extraction, reducing manual entry errors and improving reliability for safety-critical quality and compliance processes.
Smart Validation Rules
Automatically cross-checks extracted results against your specifications and acceptance criteria. Only genuine exceptions are routed for human review — freeing your team for real quality decisions.
ERP & LIMS Integration
Connects seamlessly with SAP, Oracle, LabVantage, Veeva, Microsoft Dynamics, and more. Validated data flows directly where you need it — no manual export or re-entry required.
Instant Search & Retrieval
ind any COA in seconds using product, supplier, lot number, date, or test parameter filters. Eliminate time spent searching email folders and shared drives during audits and regulatory reviews.
Automated Report Generation
Generate batch reports, supplier quality summaries, and compliance documentation automatically — ready for internal review or regulatory submission, including FDA 21 CFR Part 11 environments.
Industries Served
Built for regulated industries that depend on COA accuracy
Our COA automation solution serves organizations across the life sciences and regulated manufacturing sectors.
Pharma Manufacturing
Automate incoming raw material COA review, batch release documentation, and GMP compliance reporting.
Biotech & Life Sciences
Process COAs for reagents, cell culture media, APIs, and biological materials at any scale of operations.
Contract Research
Handle high-volume COA workflows from multiple clients and suppliers without increasing headcount.
Nutraceuticals
Verify raw ingredient quality and maintain complete traceability documentation for regulatory compliance.
Specialty Chemicals
Automate incoming quality inspection documentation and supplier COA management across your supply chain.
Medical Devices
Ensure component COAs are validated and filed to meet ISO 13485 and FDA quality system regulations.
Some Of Our 300+ Satisfied Clients
Hear From Our Happy Clients
Don’t take our word for it. Here is what a few of our current clients have to say about us.
Jennifer Field
Director, Marketing, Business Development & IT
QueBIT
John Krause
Director of IT Infrastructure
Goldfarb Properties
Donald Rauhofer
Manager of Information Technology
City of Mount Vernon
Georgette Cupo
Director of HR
Pomerantz LLP
Ira V. Major
Network Administrator
Teamsters Local 237
Annie Doresca
CFO
Jewelers of America
Richard Warren
Law Office of Richard Warren
President
Jerome Grant
IT Director
Community Access
Frequently Asked Questions about COA automation
Does the AI work with our specific COA formats?
Yes. Our AI does not rely on fixed templates. It reads COAs from any layout, supplier, or laboratory — whether clean digital PDFs, scanned paper documents, or structured spreadsheet exports. It adapts to new formats automatically without manual reconfiguration.
How long does implementation take?
Most implementations are live within 2 to 4 weeks. We handle system configuration, integration with your ERP or LIMS, staff onboarding, and validation documentation. Our team manages the process end-to-end so your internal team stays focused on their day-to-day work.
Which ERP and LIMS systems do you integrate with?
We have pre-built integrations with SAP, Oracle, LabVantage, IDBS, Veeva Vault, Microsoft Dynamics, and a range of other platforms. For less common systems, we build a custom connector during the implementation phase.
How does the system handle out-of-specification results?
When the AI detects a test result outside your defined acceptance criteria, it immediately flags the document and routes it to the appropriate team member for review. Everything in-specification is processed without human involvement — keeping your team focused on genuine quality issues.
Is the solution compliant with FDA 21 CFR Part 11?
Regulatory compliance is a core design principle, not an add-on. The system maintains a full audit trail of all document processing actions, supports electronic signature workflows, and produces documentation suitable for GMP and FDA inspection readiness. We work with your quality team to validate the system appropriately for your regulatory context.
What happens when the AI is uncertain about extracted data?
The system applies confidence scoring to every extraction. When confidence falls below a defined threshold, the document is automatically flagged for human verification. On average, this represents fewer than 10% of total COA volume — meaning 90%+ of documents are processed without any human involvement.