Pharma & Custom GxP Software · Validation Consulting
Pharma softwarebuilt audit-ready.
PharmaEddge Solutions builds software for pharma and biotech — ready-made products for quality, laboratory and operations teams, plus custom GxP systems built around the way you actually work. Designed and validated by engineers who qualify these systems for a living.
Computer System Validation
Execution Checklist
- User Requirement SpecificationPASS
- Risk Assessment · FMEAPASS
- IQ / OQ / PQ ProtocolsPASS
- Traceability MatrixPASS
- Validation Summary ReportPASS
Executed by PharmaEddge · Reviewed & approved
- GAMP 5
- Risk-based validation of computerized systems
- 21 CFR Part 11
- FDA electronic records & signatures
- EU Annex 11
- EU GMP for computerized systems
- ALCOA+
- Data integrity principles
- PIC/S
- Harmonized GMP inspection guidance
- CSA
- FDA computer software assurance
Our software
Software that removes the friction, not the control.
Ready-made products for pharma quality, laboratory and operations teams — plus custom GxP builds when nothing off the shelf fits.
Services
And the validation expertise behind it.
The same engineers who build the software also qualify systems and steer compliance programs — available to your team when you need them.
Explore services →Right-sized rigor
Category 3 systems get Category 3 effort — no over-validation, no runaway invoices.
Audit-ready by default
Every deliverable is written to be read by an inspector, not just filed away.
Remote or on-site
Delivered worldwide, hybrid or on your floor — identical documentation quality either way.
Start here
Turn the next audit into a walkthrough.
Start with a free consultation. You leave with a practical view of the risk, the right scope and the clearest next step — whether or not that step involves us.