Features

What the system actually holds.

Records, workflows, and intelligence that hold up in an inspection.

Quality operations

A deviation can open an investigation, spawn a CAPA, revise a document, and assign retraining — without copy-paste between systems.

Meaning of signature, unique identity, password re-authentication, and time-stamped records designed for 21 CFR Part 11 and EU Annex 11.

Every create, update, approve, and obsolete event is attributable. Nothing is silently overwritten.

Start from GxP-ready process templates. Adjust fields, routing, and SLAs without a six-month IT project.

See yield by product, line, shift, and batch. Investigate drops against deviations, materials, and process parameters.

Connect materials, equipment, people, and documents to the batch so investigations do not start in a spreadsheet.

Structured laboratory and process investigations with phase logic, hypothesis tracking, and QA disposition.

Controlled, role-limited views for production, QC, and warehouse — current SOP, current batch, current status.

Yuktav answers from your controlled library and cited regulations, not from the open internet.

Requirement matrices, protocol drafts, and traceability that a validation lead reviews — not a black box.

Surface similar events, likely process failure modes, and draft 5-Why or fishbone language from the record.

Detect conflicting clauses, missing references, and training impact when a specification changes.

IQ/OQ evidence, requirement specifications, and a risk-based CSA approach so you are not validating a moving target from zero.

Connect ERP, LIMS, MES, HR, and identity providers. Quality events should not live in isolation.

Corporate standards with local procedures. Shared catalogs. Site-level records. Global reporting.

SSO, RBAC, encryption in transit and at rest, session controls, and environment segregation.

45 minutes

Forty-five minutes. Bring an SOP, a deviation, or a validation gap.

Working session

Quality + validation