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Standards we work to: GAMP 5, FDA 21 CFR Part 11, EU Annex 11, ALCOA+ Data Integrity, PIC/S Guidance, ISO 9001:2015, EudraLex Vol 4, Validation Master Plan, Risk-Based · FMEA, CSA · Software Assurance, Audit-Ready Documentation, SDLC

GxP Software

Software built forregulated teams.

Purpose-built tools that help pharma quality, laboratory and operations teams move faster without losing control. Each product combines practical workflows, data integrity and validation support from the team that builds it.

The product line

Replace process friction with controlled flow

VQ Desk

AI-assisted vendor and customer questionnaire responses, grounded in the documents and approved knowledge your team provides.

Grounded in your documents · Source-linked · Human-reviewed

Column Management

Controlled chromatography column lifecycle for QC labs — receipt to destruction, with a full audit trail.

Receipt → Destruction · Access-controlled · Full audit trail

LMS

Role-based training, assessments and records that hold up in an audit.

Audit trail · E-sign · Part 11

Document Management System

Controlled document workflows, approvals, master copies and version management for different document types.

Approval workflows · Master copies · Version control

ERP

Connected business operations for pharma teams, available as a complete ERP or as individually tailored modules.

Sales · Purchase · HRMS · Inventory · Payroll

Pharma QR Code

Create QR-enabled pharma labels and standard labels for different packaging and operational needs.

QR labels · Standard labels · Controlled templates

APQR

Generate Annual Product Quality Review documents from Master Batch Records with generative AI assistance.

MBR data · AI-assisted drafting · Review-ready output

Calibration & Maintenance

Plan calibration and preventive maintenance schedules, track due dates and retain completion records.

Schedule planning · Due-date tracking · Service records

Brochure library

Share the right overview with your team

Download the complete PharmaEddge company profile or a focused two-page brochure for a specific product.

Download company profilePDF

Common principles

Built for adoption—and for inspection

Practical for the people doing the work, defensible for the quality unit reviewing it.

Controlled, audit-ready records
Access control & role separation
ALCOA+ data integrity by design
Configurable regulated workflows
Deployed on your own infrastructure
Validation support from the builders

Next step

See the software against your real process.

Bring the workflow you use today. We will show where the product fits, what it replaces and how it supports your quality system.