Certificate of Analysis Extraction and Spec Matching

• Quality Control Manager
• Head of Quality Assurance
• Supplier Quality Manager
• Stores and Warehouse Manager

Every lot of API, excipient and packaging material arrives with a supplier certificate of analysis, each in its own layout. QC compares the COA line by line with the approved specification and vendor approval before sampling and testing, and similar checks repeat for finished-product COAs sent to customers.

We build a COA checking pipeline that reads each certificate, whether a digital PDF or a scan, and extracts material, supplier, batch, dates and every test with its result, unit and limit. Test names are mapped to your specification through a maintained synonym list, units are normalised, and each result is compared with your approved limit. The system also checks that every specified test is present, that the cited pharmacopoeia matches your specification, and that batch and dates match the goods receipt. QC sees a pass, flag or missing status for every line, with the source shown beside it.

• Extracts tests, results, units and limits from digital and scanned COAs in any supplier layout
• Maps supplier test names to your specification through a QC-approved synonym library
• Normalises units and limit expressions such as NMT, NLT and ranges
• Flags out-of-limit results, missing tests and differing pharmacopoeia references
• Matches batch number and dates against the goods receipt note and label
• Keeps a per-supplier history to show results drifting towards limits

1. 01Receive the COACOAs arrive with the consignment, by email or from a supplier portal, and are linked to the goods receipt note.
2. 02Extract test dataOCR and an LLM extract header details and the test table with results, units and limits.
3. 03Map to specificationEach test is mapped to the approved specification for that material and vendor, and units are normalised.
4. 04Compare and check completenessResults are compared with limits, missing tests are listed, and batch and dates are matched to the goods receipt.
5. 05QC reviewFlags, unmapped tests and low-confidence values go to a QC reviewer, who accepts, rejects or raises a query with the supplier.
6. 06Record the outcomeChecked COA data is stored against the lot in LIMS or ERP with the reviewer's decision.

1. Intake
   • Email and supplier portal connectors
   • Goods receipt link from ERP
   • Scan station at stores
2. Extraction
   • OCR with table detection
   • LLM extractor with COA schema
   • Unit and limit normaliser
3. Specification matching
   • Approved specification library by material and vendor
   • Test name synonym library
   • Comparison and completeness rules
4. Review and records
   • QC review screen with source highlights
   • LIMS or ERP adapter
   • Supplier trend report

QC reviews every flagged line, unmapped test and low-confidence value, and decides whether to accept the COA, query the supplier or reject the lot. The COA check supports, and does not replace, your sampling and testing programme and the QA release decision.

• LIMS such as LabWare, LabVantage or STARLIMS
• ERP such as SAP for goods receipt and lot status
• Supplier portal or shared mailbox
• Document management system for approved specifications
• QMS for supplier complaints and CAPA

• New test-name synonyms added only after QC approval
• Specifications pulled from the effective version only
• No automatic lot release; status changes stay with QC and QA
• Low-confidence values always shown next to the source image
• Periodic re-check of a sample of cleared COAs by QC

• Supports vendor qualification and material control expectations under GMP, including India's revised Schedule M.
• Where COA data feeds GMP decisions, records and audit trails are designed to align with 21 CFR Part 11 and EU GMP Annex 11.

• Pharma & Life Sciences

  Batch Manufacturing Record Review

  Pre-review of executed batch manufacturing and packaging records that flags blank fields, out-of-limit values, signature gaps and unlinked deviations, with page references, before QA starts.

• Manufacturing

  Supplier Quality Certificate Verification

  Check mill test certificates and certificates of conformance against your material specs, tie heat numbers to GRNs, and flag out-of-spec, missing or reused certificates for IQC.

• Pharma & Life Sciences

  Packaging and Label Inspection

  Camera checks on cartons, labels and blister foils that verify batch, expiry, MRP and codes, compare print against approved artwork, and reject mismatches with image evidence.

• Pharma & Life Sciences

  Regulatory Dossier and SOP Q&A Assistant

  A question-answering assistant over your effective SOPs, specifications and CTD dossier modules that cites the exact section, respects versions and access rights, and says when it does not know.