Our Validation (Computer Systems, Equipment and Instrument and Cleaning) experts have vast experience in this highly-regulatory sector with a particular expertise in the Pharmaceutical, Medical Devices and Biotech industries.

We can assess your 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:

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

Clinical Trial Applications (HPRA & Ethics Committee):

• New Clinical Trial Submissions
• Substantial amendment, end of trial notification, study report submissions

Regulatory Gap Analysis:

• Due Diligence on Marketing Authorisation Files
• Marketing Authorisation Compliance Dossier Review

Pharmacovigilance:

• Risk Management plans
• Training
• Expedited reporting to Health Authorities
• Submission of Periodic Safety Update Reports

Pharmaceutical Quality Management System:

• Design and implement new QMS complying to regulatory requirements
• Undertaking a review for current QMS
• Development and maintenance of internal compliance processes (SOP writing)
• Audit/inspection-readiness programme
• Incorporating Quality Risk Management principles and tools to QMS