--- title: "Sainapse: GxP Document Intelligence for Pharma & Life Sciences" description: "Pharma purchase orders read into SAP under GxP: audit trail, human sign-off, validation-ready posture. Not a compliance certification." canonical_url: "https://www.sainapse.ai/resources/solutions/pharma-life-sciences" markdown_url: "https://www.sainapse.ai/resources/solutions/pharma-life-sciences.md" text_url: "https://www.sainapse.ai/resources/solutions/pharma-life-sciences.txt" archetype: "solution-leaf" --- # Sainapse: GxP Document Intelligence for Pharma & Life Sciences Solution ## Document intelligence for GxP purchase orders Purchase orders reach SAP under GxP constraints: Sainapse extracts every SKU, batch, and supplier field, matches it to validated master data, and writes the order with a full audit trail. Human sign-off gates every write. Nothing here claims compliance certification; it describes the posture your validation team can inspect. On this page: - [The problem](https://www.sainapse.ai/resources/solutions/pharma-life-sciences#resources_solutions_pharma_life_sciences_03) - [Proof](https://www.sainapse.ai/resources/solutions/pharma-life-sciences#resources_solutions_pharma_life_sciences_04) - [How it works](https://www.sainapse.ai/resources/solutions/pharma-life-sciences#resources_solutions_pharma_life_sciences_05) - [Status quo](https://www.sainapse.ai/resources/solutions/pharma-life-sciences#resources_solutions_pharma_life_sciences_06) - [What it runs on](https://www.sainapse.ai/resources/solutions/pharma-life-sciences#resources_solutions_pharma_life_sciences_07) - [Questions](https://www.sainapse.ai/resources/solutions/pharma-life-sciences#resources_solutions_pharma_life_sciences_08) Updated August 2026 The problem ## PO-to-SAP entry doesn't pause for GxP A pharma shared-services team can't just retype a purchase order the way a generic operations group would. Every field that lands in SAP has to trace back to a source document, every automated step needs an audit trail a validation team can walk through, and 21 CFR Part 11 and EU Annex 11 set the bar for what counts as evidence. Generic OCR tools extract text; they don't produce that trail, and a person re-keying the order by hand produces evidence only as good as their notes. For the COO or shared-services lead running that queue, the order doesn't stop at extraction. It has to match batch and lot data against SAP master data, resolve ambiguity without guessing, and leave a record an auditor can review months later, not just a payload a person keyed by hand. Proof ## What this looks like in production ### Under 60 seconds for orders that clear straight through A Fortune 500 pharmaceutical company was hand-keying PDF and unstructured Excel purchase orders into SAP at 15+ minutes each. Sainapse now reads the order, matches every SKU, batch, and supplier to SAP master data, and hands operations a payload ready to post. For the ~95% of orders that clear straight through, that takes under 60 seconds. ### Master data matched before write Every SKU, batch ID, and supplier code is resolved against SAP master data before the order posts, so mismatches surface before SAP ever sees them, not after a rejected order comes back to the queue. ### A person makes the exceptions call When Sainapse isn't confident about a field, the order goes to a person for review instead of into SAP. Several thousand POs a month move through the same pipeline, in whatever language the supplier used. How it works ## Extraction, validation, and the write, with a full record ### 1. Sainapse reads the order PDF, scanned fax, or unstructured Excel: Sainapse reads the purchase order in context, without a per-supplier template. Every extracted field is logged against the source document it came from. ### 2. Sainapse validates against SAP master data SKU, batch ID, lot, and supplier code are matched to SAP's own master data before anything moves forward. A field Sainapse isn't confident about routes to a person instead of guessing. ### 3. Sainapse writes the order, with sign-off and a trail High-confidence fields post straight to SAP. Everything a reviewer touches is logged with what changed, who changed it, and when: the record a validation team expects to see. Status quo ## Sainapse vs. manual entry and generic OCR Manual keying and generic OCR both stop short of what a GxP-audited process needs: a record that shows not just what changed, but why, and who signed off. | | Manual entry | Generic OCR | Sainapse | | --- | --- | --- | --- | | Audit trail | Only as good as the keyer's notes | Extracts text, not evidence | Every field logged to source, every override logged to a person | | New PO formats | Needs manual rework each time | Needs a template per supplier | Reads any layout in context, no template | | Master data match | Manual lookup, error-prone | Not attempted | Matched against SAP before the write | | Human sign-off | Implicit in who typed it | None | Explicit review on every low-confidence field | | Exception handling | Whatever the keyer decides | Drops into a queue with no triage | Routed by confidence, with reasoning attached | ## What it runs on - **Posture**: Audit trail on every extracted field and every human override, built for a validation team to inspect, not a compliance certification claim. - **Standards**: Built with 21 CFR Part 11 and EU Annex 11 evidence expectations in view: not a certification, a design posture. - **Sign-off**: Every low-confidence field routes to a person before it posts; nothing auto-writes past a threshold your team sets. - **Retention**: Extraction records and override history retained for as long as your own document-retention policy requires. - **Formats**: PDFs, unstructured Excel, scanned faxes, and phone photos, through the same extraction pipeline. - **Writes to**: SAP, as a payload ready to post, or to a reviewer's queue when confidence is low. - **Powered by**: Document Intelligence · Intelligent Field Extraction · Master Data Mapping & Validation · Human-in-the-Loop Exception Handling ## Common questions ### Does Sainapse certify compliance with 21 CFR Part 11? No. Sainapse doesn't issue or claim any compliance certification. What it provides is a posture: every extracted field traces to its source, every human override is logged with who and when, and that record is built for your own validation team to review and sign off on. ### What does the audit trail capture? Every field Sainapse extracts is logged against the source document it came from. Every field a reviewer changes is logged with what changed, who changed it, and when. Nothing writes to SAP without that trail attached, so a validation team can reconstruct any order after the fact. ### Does a person still sign off on the order? Yes, on anything Sainapse isn't confident about. High-confidence fields post straight to SAP; low-confidence ones route to a reviewer instead of guessing, and that review is logged as part of the order's record. Human sign-off is a control, not an afterthought. ### How does Sainapse avoid hallucinating a field value? Sainapse only writes a value it can match against your SAP master data with high confidence. Anything it can't resolve that way (a SKU it doesn't recognize, a supplier code with no clean match) goes to a person instead of a guessed value. ### How long are extraction and override records retained? As long as your own document-retention policy requires. Sainapse doesn't set a separate clock. Records live alongside the order they belong to, so a review months later pulls the same evidence a reviewer saw at the time. Related ## Related reading ### Other document types under the same GxP posture - [Invoice automation software](https://www.sainapse.ai/use-cases/invoice-automation): Extraction, master-data validation, and ERP write for AP invoices (the same audit-trail architecture, a different document type). - [Purchase order automation software](https://www.sainapse.ai/use-cases/automate-purchase-order-processing): The general PO-to-ERP motion this GxP posture is built on top of. ### How Sainapse handles evidence and access - [Security](https://www.sainapse.ai/security): Data handling, access control, and retention practices behind every extraction and write. ## See it running on your own SAP stack - [Book a demo](https://www.sainapse.ai/book-a-demo) ## Sitemap See the full [Sainapse sitemap](https://www.sainapse.ai/sitemap.md).