Validation & Quality Management Services

IT Quality Management

With our experience in developing and implementing validation strategies and supporting Quality Management Systems (including ISO9001:2000 / TickIT) in both small specialist companies and global enterprise organisations, A1 IT Compliance can provide support to your business and IT communities in the development of appropriate pragmatic tools and processes to support your computer system validation, infrastructure and equipment qualification  and IT Quality Management including:

• Standard Operating Procedures for QMS Management and SOP Development
• Validation Policies & Procedures
• IT Project Management and Software Lifecycle Policies, SOPs and Guidelines
• Validation and Lifecycle Deliverable Templates

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