What is EHS and quality software for pharma and biotech?

EHS and quality software for pharma and biotech is a validation-friendly platform that manages GMP deviations, CAPA, change control, supplier qualification, equipment calibration, and complaint intake with electronic signatures and an immutable audit log aligned to ALCOA+ data-integrity principles.

Does QEHS meet 21 CFR Part 11 electronic-records requirements?

Yes. Audit log is immutable, electronic signatures carry the required attestation text, and record retention controls are configurable per procedure.

Can validation documentation (IQ/OQ/PQ) be produced from QEHS?

QEHS provides a Validation Support Pack on Enterprise that includes the URS, risk assessment, and traceability matrix templates aligned to ISPE GAMP 5.

Industries / Pharma & Biotech

EHS & Quality Software for Pharma & Biotech

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

EHS and quality software for pharma and biotech covers deviation management, CAPA, change control, and supplier quality for manufacturers and CDMOs.

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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

Frequently asked questions

What is EHS and quality software for pharma and biotech?: EHS and quality software for pharma and biotech is a validation-friendly platform that manages GMP deviations, CAPA, change control, supplier qualification, equipment calibration, and complaint intake with electronic signatures and an immutable audit log aligned to ALCOA+ data-integrity principles.
Does QEHS meet 21 CFR Part 11 electronic-records requirements?: Yes. Audit log is immutable, electronic signatures carry the required attestation text, and record retention controls are configurable per procedure.
Can validation documentation (IQ/OQ/PQ) be produced from QEHS?: QEHS provides a Validation Support Pack on Enterprise that includes the URS, risk assessment, and traceability matrix templates aligned to ISPE GAMP 5.

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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