Our Computer System Validation experts have vast experience in this highly-regulatory sector with a particular expertise in the Pharmaceutical, Medical Devices and Biotech industries. We specialise in short term projects and will work with your staff to provide a bespoke compliant solution at an affordable cost.

We have demonstrated expertise and completed projects in;

Validation Change Controls
Spreadsheet validation
Manufacturing Control System (MCS) validation
Building Management System (BMS) validation
ERP Systems
Laboratory Equipment validation
Autoclave Validation
HVAC Heating Ventilation and air-conditioning
Logistics Systems validation
Environmental Room Qualification
Thermal Mapping Studies
Batch Report validation
eDHR (electronic Device History Record) validation

We have completed projects previously using the following SDLCs

V-Model
Waterfall Model
Agile methodology

We can assess your computer system’s compliance or current validation status against regulatory and industry standards. Our services include generating the full set of validation documents to ensure compliance with:

GAMP 5 : Good Automated Manufacturing Practices
FDA 21 CFR Part 11 on Electronic Records & Electronic Signatures
FDA 21 CFR 210 and 21 CFR 211
EU GMP Annex 11 for Computerised Systems
EU GMP Annex 15 Qualification and Validation

We also take a Risk Based approach:

Utilise a risk-based approach to ensure compliant computerised systems
Generate and conduct risk assessments
Generate and conduct Failure Mode and Effects Analysis (FMEA)