Validation and compliance to define, prove and maintain your regulatory requirements.
Our highly experienced consulting team can provide your business with support in the specification, design, ensuring GxP compliance and adherence with all applicable regulations and best practice guides, including 21 CFR Part 11 & Good Automated Manufacturing Practice (GAMP) for the procurement, implementation, testing, validation and maintenance of systems.
An essential part of any pharmaceutical, biotechnology, consumer healthcare, medical device and veterinary organisation, computer systems provide vital roles within communication, data management, process control, records storage, business performance and regulatory compliance. Key business systems include validation and compliance services for: Document management (eDMS), enterprise (ERP / MRP), building management (BMS), laboratory management (LIMS), control systems (PLC) and databases.
• Site policy for computer systems and electronic data management
• Support with vendor assessment and selection
• Business process improvement and introduction of smart use of IT tools
• Regulatory inspection readiness
• Computer systems validation strategy and preparation of the computer systems validation master plan (VMP)
• Development and implementation of quality systems for the management of computer systems and electronic data within the regulated industries
• Provision of interim and part-time IT quality management support to your business (on-site and remote services)
• 21 CFR Part 11 assessment and remediation
• Implementation and management of your system development life cycle (SDLC)
• GAMP5 compliance and implementation of ISPE guidelines
• Clinical trials directive (CTD) compliance
• Statistical data analysis for clinical studies and provision of SAS experts
• Risk assessment for computer systems
• Auditing of computer systems and electronic data management
• Validation project management for computer systems
• QA compliance for computer systems
• Interim computer systems manager support