We stay current with the latest industry standards and best practices such as Good Automated Manufacturing Practices (GAMP), ISO andFDA, MHRA Guide to software validation.
We have successfully developed and deployed the full suite of CSV documentation for systems ranging in complexity from spreadsheet validation to integrated platform solutions. Spark is poised to deliver a right-sized and integrated solution to assist you in meeting your Computer Systems Validation needs:
Enterprise Systems/Business Information Systems
- Enterprise Resource Planning (ERP)/SAP
- Quality Management System (QMS)
- Laboratory Information Management System (LIMS)
- Document Management System
- Business Process Management System
Manufacturing Process Control Systems, Building, Facility, Utility Control Systems
- PLC, HMI & SCADA based Systems
- Distributed Control System (DCS)
- Building Management System (BMS)
- Vision Systems, Manufacturing Execution Systems
Laboratory, Clinical Trial Systems Validation
- Analytical Software,Database Software
- Personal Computers
- Quality Workflow and Document Management Systems
- Clinical Trial and Data Management Systems
- Medical Information Systems
Applications/IT Infrastructure
- Data Archive Management Systems
- Table / Report Generation Systems
- Application Database Systems
- Physical/Virtual Server Applications
- Web-Based Applications
SOP Preparation
- CSV site policy procedures.
- CSV Inventory management procedures.
- CSV Gap Analysis Reports procedures.
- Risk Assessment procedures.
- Configuration Management procedures.
- Backup, Restoration and electronic housekeeping procedures.
- Security Access procedures.
- Disaster Recovery procedures.
- Time synchronisation procedures.
- Control of Suppliers procedures.
- Network management procedures.
- Record retention policies
- Computer system Compliance Tutorials and Corporate Presentations