Six problems BioWise solves
out of the box
Each use case is a real workflow quality teams run today — manually, slowly, and with incomplete data. BioWise makes them fast, connected, and audit-ready.
GMP Certificate Expiry Monitoring
The Problem
Certificate expirations are tracked manually in spreadsheets or buried inside supplier portals. By the time someone notices, the batch has already been released — or worse, held.
How BioWise Solves It
BioWise ingests certificate records from Veeva, SharePoint, and supplier uploads, extracts expiry dates automatically, and fires alerts 90 days before any GMP, CoA, or qualification certificate lapses. The right person gets notified before the problem exists.
"Show me all certificates expiring in the next 90 days"
3 certificates flagged: CoA-TRE-012 (18 days), GMP-ONCOBIOLOGICS (42 days), ISO-CRYOPACK (87 days). Each with supplier contact, renewal checklist link, and affected product list.
Supplier Impact Assessment
The Problem
A critical API supplier fails a GMP audit. Figuring out which products, batches, and open change controls are affected requires manually cross-referencing SAP BOMs, Veeva qualification records, and TrackWise CAPA history — a process that takes days and is rarely complete.
How BioWise Solves It
BioWise traverses the ontology graph from supplier to every connected entity in seconds: products using the API, active batches in scope, open CAPAs referencing the supplier, and change controls that may need re-evaluation. A complete impact map without a single manual lookup.
"Which products are at risk if OncoBiologics API GmbH goes on hold?"
2 products affected (SOL-mAb IV, Veneclair Phase III extension), 1 batch on hold (MAB-2025-007), 1 open CAPA (CAPA-SOL-001 critical). Recommended actions: escalate to QA VP, initiate secondary supplier qualification.
Cross-System Audit Trail
The Problem
An FDA inspector asks for the complete qualification and certificate history for a specific manufacturer. That record exists across multiple systems with no single thread connecting them — and compiling it manually takes weeks, with gaps.
How BioWise Solves It
BioWise maintains a unified, immutable audit trail across all connected systems. Every certificate upload, review action, approval signature, deviation record, and system event is logged with user identity, timestamp, and source system — and instantly queryable as a single compliant record.
"Show me the complete GMP qualification history for Solaris San Diego site"
49 audit entries returned in 1.8s: initial qualification (2024-03-12), 3 annual re-qualifications, 7 certificate uploads, 2 deviation investigations, 1 CAPA closure. Full 21 CFR Part 11 compliant record with electronic signatures.
Certificate of Analysis Extraction
The Problem
CoAs arrive as PDFs from dozens of suppliers in different formats. Someone has to open each one, find the relevant test results, transcribe them into the QMS, and manually link them to the corresponding batch record — every time.
How BioWise Solves It
BioWise's AI extraction agent reads incoming CoA PDFs, identifies the correct template from the ontology, extracts all test results with their units and specifications, flags any OOS values, and links the record to the batch automatically — without human transcription.
"Extract and validate CoA for venetoclax batch VEN-2026-002"
23 fields extracted: identity (HPLC), assay (99.8% — PASS), impurities (all within ICH Q3A limits — PASS), residual solvents (PASS), particle size (D90: 42.3μm — PASS). 0 OOS values. Linked to batch VEN-2026-002. Ready for QC review.
Change Control Impact Assessment
The Problem
A specification change for an excipient needs to go through change control. Determining all the affected products, batch records, validation studies, and supplier agreements requires manually tracing dependencies across every relevant system — work that often gets skipped or done incompletely.
How BioWise Solves It
BioWise's impact assessment agent traverses the full dependency graph for any proposed change. It identifies every product using the excipient, every validated method referencing the specification, every batch currently in QC, and every supplier contract that may be affected — before the change control is even opened.
"What is the impact of changing the particle size spec for trehalose from D90 ≤50μm to D90 ≤45μm?"
Impact scope: 1 product (SOL-mAb IV), 2 batches in QC (MAB-2025-006, MAB-2025-007), 1 validated method (USP <429>), 1 supplier agreement (ExciPure Solutions BV). Required actions: method re-validation, supplier notification, change control CC-2026-004 recommended.
Regulatory Compliance Copilot
The Problem
Quality teams spend significant time answering ad-hoc regulatory questions — looking up 21 CFR requirements, checking GMP obligations, interpreting FDA guidance against their specific situation. This knowledge is scattered across regulatory documents, internal SOPs, and tribal knowledge.
How BioWise Solves It
BioWise's Compliance Copilot answers regulatory questions in the context of your specific system and data. It cites the exact regulatory requirement, cross-references your current qualification status, and flags gaps — with a complete audit trail of every question and answer it generates.
"Does our current supplier qualification program meet 21 CFR 211.84 requirements for API suppliers?"
Analysis: 4 of 6 suppliers fully compliant. 2 gaps: RareSynth Pharmaceuticals Ltd — conditional approval status requires enhanced monitoring per 211.84(d)(2). OncoBiologics API GmbH — GMP certificate expires 42 days; 211.84(a) requires current qualification. Recommended: initiate re-qualification workflow for both.
Every use case is compliant by default
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