Finance, compliance, and HR for biotech and pharma
R&D spend tracked by program, grant and milestone revenue recognized under ASC 606, and clinical-trial cost accounting on one ledger, real DB-backed GRC for FDA 21 CFR Part 11, the HIPAA Security Rule, SOC 2, and HITRUST CSF in a GxP context, and HR for lab and clinical teams. One system, honest about the edges.
Illustrative product view
Finance: R&D spend, grant and milestone revenue, trial costs
Biotech finance runs by program and by trial, not by calendar month. Fintra keeps a program-dimensional ledger so R&D spend, grant funding, and clinical-trial costs land on the right program and study at entry, recognizes grant and milestone revenue under ASC 606, and accounts for inventory as you move toward supply, all on the same books.
- Program- and study-dimensional general ledger, so every cost codes to a program at entry
- Grant and milestone revenue recognized under ASC 606, including the milestone method, posted to the GL
- Clinical-trial cost accounting by study, site, and program with accruals
- Inventory accounting for lots and batches as you scale toward supply
- Multi-currency for trials and partners run across countries, with real currency translation
Security & compliance: Part 11, HIPAA, SOC 2, and HITRUST in a GxP context
Life sciences answers to the FDA, to health-data law, and to partners who audit you. Fintra carries that stack as real GRC. The HIPAA Security Rule and SOC 2 are seeded control libraries. FDA 21 CFR Part 11 and HITRUST CSF are mapped so you can prepare and evidence, and both sit inside the broader GxP and GMP regulatory context your quality system already lives in.
| Framework | In catalog | How Fintra takes it |
|---|---|---|
| SOC 2 | Seeded | Mapped control library, evidence requirements, audit-ready baseline |
| HIPAA Security Rule | Seeded | Mapped control library for ePHI safeguards |
| FDA 21 CFR Part 11 | Mapped | Prepare-for: e-records and e-signature controls and evidence |
| HITRUST CSF | Mapped | Prepare-for: mapped onto the canonical control library |
| GxP / GMP context | Context | Regulatory environment the controls map toward, not a separate scored framework |
Governing agents that touch trial and health data
AI now drafts study documents, summarizes safety data, and moves records that fall under Part 11 and HIPAA. Part 11 is built on attributable, tamper-evident records, which is exactly what the governance ledger produces. Fintra records a policy verdict and an Action Trust Score for every agent action touching trial or health data, to a hash-chained ledger, so the electronic trail behind your automation is attributable and verifiable.
- Every agent access to trial or health data produces a recorded, attributable verdict
- An Action Trust Score per agent, so drift is caught before it becomes a data-integrity issue
- Decision Intelligence: an explanation of why any single action got its verdict
- A tamper-evident, hash-chained ledger that fits the spirit of Part 11 record controls
HR: lab payroll, training and certification, cleared personnel
Lab and clinical staff carry GxP training records and certifications that gate what they can do, and grant-funded roles carry effort that has to be accounted for. Fintra pays them on a verified tax engine, models their compensation, and keeps training, certification, and clearance status on the employee record next to the work it authorizes.
- Payroll on a verified, integer-cents tax engine with multi-state withholding, posted to the GL
- Grant-funded roles allocated to programs so labor lands on the right study and grant
- Training and certification status tracked on the employee record and in the skills graph
- Cleared-personnel status captured where federal or DoD-funded work applies
Spreadsheets and point tools vs one system
| Workflow | Spreadsheets + point tools | Fintra |
|---|---|---|
| R&D by program | Re-tagged after the close in Excel | Program dimension coded at entry |
| Milestone revenue | Tracked in a side schedule | ASC 606 milestone recognition posted to the GL |
| Part 11 evidence | Assembled for each partner audit | Mapped Part 11 controls with reusable evidence |
| Lab-staff training | Certification spreadsheet outside HR | Training and certification on the employee record |
Frequently asked questions
Does Fintra capitalize R&D for biotech?
It tracks R&D spend by program on a dimensional ledger, but under US GAAP most R&D is expensed as incurred (ASC 730), so Fintra does not automatically capitalize it. Capitalization stays a documented policy judgment, and the program-level detail gives you the basis for whatever policy your auditors accept.
How does Fintra handle grant and milestone revenue?
Grant and milestone revenue is recognized under ASC 606, including the milestone method, and posted to the same general ledger as spend, so recognized revenue and the program costs behind it live on one set of books rather than drifting between a schedule and the ledger.
Is Fintra a validated Part 11 system?
No. Fintra maps FDA 21 CFR Part 11 requirements onto its control library and helps you prepare, draft policies, and collect evidence, and its governance ledger produces attributable, tamper-evident records. It does not deliver a validated GxP system or a CSV package, that validation is performed by your quality and validation teams.
Which life-sciences frameworks are DB-backed?
The HIPAA Security Rule and SOC 2 are seeded control libraries, and FDA 21 CFR Part 11 and HITRUST CSF are mapped for prepare-and-evidence. GxP and GMP are the surrounding regulatory context the controls map toward, not separate scored frameworks in the catalog.
Can Fintra track lab-staff training and certifications?
Training and certification status live on the employee record and in the skills graph, next to the payroll and program allocations they relate to. A dedicated GxP training system with automated re-certification alerting is roadmap, and cleared-personnel tracking applies only where federal or DoD-funded work is in scope.
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