Industries / Pharma & Biotech

Pharma & Biotech

GMP deviations, CAPA, change control, and supplier quality — validation-friendly.

Pharmaceutical manufacturers and CDMOs run deviation/OOS/OOT management, CAPA, change control, and supplier quality on a validation-friendly platform (ALCOA+ principles, 21 CFR Part 11 controls).

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Programs this industry runs here

Deviation + OOS / OOT management
CAPA + effectiveness checks
Change control (GMP)
Supplier qualification + audit
Equipment qualification + calibration
Complaint + adverse-event intake
Annual Product Review (APR / APQR)

Regulations and standards

21 CFR Part 11 (electronic records / signatures)
21 CFR 210/211 + ICH Q7, Q9, Q10
EU GMP Annex 11
ISO 13485 (medical-device sister systems)
ALCOA+ data integrity

Terrain we expect

Validation lifecycle → sandbox tenants + immutable audit log
Electronic signatures with binding attestation statements built in
Regulated-data residency (EU / UK / US) selectable per tenant

Explore other industries

Manufacturing Construction Oil & Gas Energy & Mining Utilities Healthcare Food & Beverage Transport & Logistics Retail Hospitality Government & Defense

Ready when you are

See how Pharma & Biotech programs run on one tenant.

30-minute demo tailored to your industry's regulations and field conditions.

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