A1 IT Compliance
European Vendor & CSV Auditing
Electronic Records and Electronic Signatures
We can help ensure your systems comply with the latest guidance and regulations for electronic records and signatures. Whether it is working with your own internal ERES Compliance and Assessment process or, through our own ERES and 21 CFR Part 11 Control Framework.
We can help you in the implementation project management and deliverables production including:
- ERES / 21 CFR Part 11 Compliance Assessment
- Specification of Risk-based ERES Controls Tailored to suit your organisation
- Integration of Controls with System and / or QMS Documentation
- Remediation Plans and Remediation Management
- Compliance Reporting
Computer System Validation Consultancy
Based on our knowledge of GAMP and Industry Best Practices for Computerised System Validation we provide risk-based validation services for small and large systems alike. We have experience in validating computer systems across the GxP spectrum from Laboratory Information Management systems, Manufacturing Materials Management and Dispensing Systems to Clinical Trial Management, Regulatory Document Management Submissions (CTD / eCTD) and Pharmacovigilance systems as well as infrastructure services including IT Service Desks, Data Centres and Networks.
We can help you in the implementation project management and deliverables production including:
- Validation / Qualification Plans
- Validation / Qualification Protocols
- User Requirement Specifications & Requirement Traceability matrices
- Review and Oversight of Technical Activities / Documentation
- Test Plans, Specifications and Reports
- System Validation and User Test Management
- Validation / Qualification Reports
- System Administration, Maintenance and Usage SOPs