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General Information

GMP & Quality

A complete Good Manufacturing Practice quality system — covering deviations, CAPA, change control, complaints, document management, quality investigations, recall management, and print requests. Built for regulated pharma environments where every record counts.

Explore GMP Modules

GMP Modules

Eight interconnected quality modules covering the full GMP compliance lifecycle — from deviation capture to product recall.

CAPA

Corrective and Preventive Actions from initiation through root cause analysis, implementation, and effectiveness verification — fully linked to source deviations.

Open

Change Control

Initiate, assess, approve, and implement changes with cross-functional workflows, impact assessment across affected documents and equipment, and full traceability.

Open

Complaints Management

Log, investigate, and close customer and market complaints with structured workflows, regulatory reporting triggers, and linkage to CAPA and recall where required.

Open

Deviations

Capture planned and unplanned deviations, classify by severity, assign investigation owners, and escalate to CAPA — with a complete audit trail from detection to closure.

Open

Document Management

Controlled lifecycle for SOPs, protocols, and batch records — versioning, approval workflows, periodic review scheduling, and distribution control. Nothing gets used without authorization.

Open

Print Requests

Authorize document print requests so only current, approved versions reach the production floor — with a logged record of who printed what, when, and against which revision.

Open

Quality Investigations

Structure formal quality investigations — assign investigators, capture findings, apply root cause methodologies, and link conclusions to corrective actions and affected batches.

Open

Recall Management

Manage product recalls with escalation workflows, distribution traceability, regulatory notification tracking, and quantity reconciliation — built to meet FDA and EMA recall requirements.

Open

Key Features

Closed-Loop Quality System

Deviations link to investigations, investigations link to CAPA, CAPA links to change control — nothing falls through the gaps.

Inspection-Ready Audit Trail

Every record, approval, rejection, and edit is timestamped and user-attributed. When an FDA or EMA inspector asks — the answer is already there.

Electronic Signatures

Approval workflows with electronic signatures aligned to 21 CFR Part 11 and EU Annex 11 — no paper routing, no lost sign-off sheets.

Cross-Module Impact Assessment

A change or deviation automatically flags affected SOPs, equipment qualifications, and lab specifications — so nothing gets missed during impact review.

CAPA Effectiveness Tracking

Schedule and record effectiveness checks after CAPA implementation — satisfying the regulatory requirement to verify that corrective actions actually worked.

Deviation Trend Reporting

Track deviation frequency by type, product, line, or area — and detect recurring issues before they become repeat findings in an inspection.

Controlled Document Distribution

Only current, approved versions reach the production floor. Obsolete versions are automatically withdrawn and print requests are logged against the authorised revision.

Recall Traceability

Track recalled batches through the distribution chain, manage regulatory notifications, and reconcile returned quantities — with the documentation regulators expect.

Need Help Getting Started?

Each GMP module has dedicated documentation covering configuration, workflows, and daily usage. Start with the module most relevant to your current compliance priorities.