ERP for pharmaceutical companies built for validation, not just production.
Custom ERP for pharmaceutical manufacturers and compounders — 21 CFR Part 11 e-signatures, batch record genealogy, deviation and CAPA management, and a system that survives an FDA audit because it was built for one.
A generic manufacturing ERP isn't validated, and validation isn't optional.
Most pharma operations start on a general manufacturing ERP or a spreadsheet stack, then discover the gap the hard way: FDA doesn't just want you to track a batch, it wants proof the system that tracked it is trustworthy. That means computer system validation (CSV) — IQ/OQ/PQ documentation showing the software does what it claims, every time — and generic ERPs weren't built with that paper trail in mind.
21 CFR Part 11 requires electronic signatures with real authentication, not a checkbox next to a name. Every batch record needs an unbroken chain of who touched what, when, and why. A deviation from spec can't just get noted in a comment field — it needs a documented investigation, a root-cause analysis, and a CAPA (corrective and preventive action) that closes the loop, all timestamped and audit-ready.
Bolting an e-signature plugin onto NetSuite or a generic MES gets you halfway there. It looks compliant in a demo. It falls apart the moment an FDA investigator asks for the audit trail behind a specific signature, or asks why the system allows a batch to move forward with an open deviation.
Compliance built into the data model, not layered on top.
We build batch genealogy, electronic signatures, and audit trails as first-class parts of the schema — not a module you enable later. Every batch record captures who signed what, when, under what authentication, with a full revision history that can't be edited out. Deviations open a structured investigation workflow automatically; a CAPA has to close before the lot it's tied to can release.
The system is validated the way FDA expects: we document IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification) as part of the build, not as a retrofit exercise your QA team scrambles to produce before an audit.
Honest tradeoff: if you're a single-product compounder running well within a packaged system like MasterControl or a pharma edition of an existing MES, and your validation burden is already handled, that's a legitimate buy — rebuilding a working validated system from scratch to save on license fees is a bad trade. Custom earns its cost once you're running multiple product lines, integrating validation across disconnected point systems, or paying for modules you don't use to get the one feature you need.
We ship the modules you need first, then add the rest. Most clients don't need every module on day one.
21 CFR Part 11 e-signatures
Authenticated electronic signatures on every batch record, deviation, and CAPA — with the identity verification, meaning, and timestamp binding Part 11 requires, not a name typed into a text field.
Batch record genealogy
Full forward and backward trace from raw material lot through every manufacturing step to finished-good lot and shipment — with an immutable revision history for every edit.
Deviation & CAPA management
A deviation from spec opens a structured investigation workflow automatically; the tied lot can't release until root cause is documented and the corrective action is closed.
Computer system validation (CSV)
IQ/OQ/PQ documentation produced as part of the build process, so the system arrives audit-ready instead of requiring a validation project after go-live.
Quality holds & release management
A failed QC result or open deviation blocks lot release automatically — no shipment leaves without a documented, signed release decision.
Change control
Formal change-request workflow for any process, spec, or system change that could affect product quality, with approval routing and full history.
Audit trail & 21 CFR Part 11 logging
Every create, edit, and signature event logged with who, when, and why — queryable in the format an FDA investigator actually asks for.
Stability & expiry tracking
Stability study data tied to batch and formulation, driving expiry dates and re-test schedules automatically instead of a manual tickler file.
Supplier & material qualification
Approved supplier lists, incoming material qualification, and certificate-of-analysis tracking tied to every raw material lot before it enters production.
How a custom pharmaceutical ERP gets built.
Same structure every time. We ship the first module to your team in 4–8 weeks, then build the rest while they're already using it.
- 01
Discover
1–2 weeks. We sit with your team, map workflows, and pick the first module to ship.
- 02
Architect
1–2 weeks. Data model, integrations, deployment topology. Documented before any code.
- 03
Build slice 1
3–5 weeks. First production module — usually the highest-pain part of your current workflow.
- 04
Build slices 2–N
1–3 months. Additional modules deployed continuously. Each integrates with the existing data model.
- 05
Run
Ongoing. We stay on after launch — bug fixes, new features, integrations as your business changes.
Built to integrate with the systems you already use.
The integrations below come up most often for pharmaceutical operators. Anything with an API is fair game — these are just the common ones.
- LIMS (LabWare, Thermo SampleManager)
- MES / equipment data historians
- QuickBooks Online / Sage Intacct / NetSuite (financials only)
- Document management & eQMS (MasterControl, Veeva Vault)
- Barcode / serialization hardware (DSCSA track-and-trace)
- Avalara (multi-state / multi-jurisdiction tax)
- Cold chain & controlled-substance storage systems
- EDI for distributor and wholesaler customers
- Identity/authentication providers (for Part 11 e-signature binding)
- BI / reporting (Metabase, Looker)
Custom ERP for other industries.
Modern, boring, hireable.
We build on standard tools your future team will be able to hire for. No proprietary platforms.
- Next.js
- TypeScript
- React
- Tailwind
- Postgres
- Prisma
- Drizzle
- Redis
- Vercel
- Railway
- Fly.io
- Docker
- Clerk
- WorkOS
- Auth0
- Stripe
- Plaid
- QuickBooks API
- Postgres views
- Metabase
- Recharts
The proof we ship ERPs.
Clear answers
for complex builds.
Clear answers on timelines, pricing, ownership, and what shipping actually looks like with a senior engineering team.
If a system like MasterControl or a pharma-specific MES already covers your validation and batch-record needs within your budget, buying is the right call — we'll tell you that on a discovery call if it's true. Custom starts winning once you're managing multiple product lines, stitching together disconnected point systems for validation, or paying for a suite to get one feature you actually need.
Yes, if it's built that way from the start. We treat 21 CFR Part 11 e-signatures, immutable audit trails, and IQ/OQ/PQ validation documentation as core requirements, not add-ons — the same standard packaged validated systems are held to. The difference is the workflows fit how your plant actually runs instead of how a generic module assumes it runs.
Food and beverage traceability is about lot genealogy and shelf life. Pharma adds a regulatory layer on top: Part 11 electronic signatures, formal deviation/CAPA workflows, computer system validation (IQ/OQ/PQ), and change control — requirements tied to FDA drug manufacturing regulations that food production doesn't carry.
Any out-of-spec result or process deviation opens a structured investigation record automatically, tied to the affected batch. The batch can't release until root cause is documented and a corrective/preventive action is recorded and closed — the workflow enforces the sequence instead of relying on someone remembering the SOP.
Usually $90k–$320k and 4–6 months for batch genealogy, Part 11 e-signatures, deviation/CAPA, and validation documentation, plus your core integrations (LIMS, eQMS, financials). Multi-site rollouts and full serialization/DSCSA track-and-trace are common phase-two additions.
Tell us your current systems, what's breaking, and what you'd want a fitted ERP to do — we'll come back with a written scope and a fixed quote.