Solutions · Pharma & Biologics
Pharma & Biologics
Electronic batch records, DSCSA, and release under Part 11.
Electronic batch records with review-by-exception, dual-signature batch release with segregation of duties, DSCSA serialization with EPCIS export, LIMS with OOS and trending, and ICH stability pull schedules.
What changes. Batch release is re-authenticated, reasoned, and append-only — signatures enforced by the database.
Inside Pharma & Biologics
Different screens for a different job — this is the Pharma & Biologics stack running in the app.
The stack for Pharma & Biologics
The modules that matter here — all on one database, all sharing the same records.
Pharma & Biologics
Compound registry, IND programs, and PPQ.
QMS
Deviations, CAPA, audits — scored live, signed under Part 11.
Manufacturing
BOMs, routings, shop floor, and batch records.
Clinical Trials
Studies, EDC, eTMF, IRT, and eConsent.
Pharmacovigilance
ICSRs, signals, aggregate reports, and MDR.
R&D
ELN, LIMS, biobank, and assays.
The regulations, named
Not "compliance-ready" — the actual frameworks, with the workflows and live readiness that back them.
- 21 CFR Part 11
- DSCSA / EPCIS
- GMP
- ICH stability
See the Pharma & Biologics stack on your own data.
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