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Since the costs of implementing a validated system typically add between 30% to 60% to the total cost of system ownership, life science companies must develop cost-effective strategies and relationships with experienced validation partners to achieve efficiencies that will mitigate cost. How much validation is enough to satisfy regulators and business partners? CTG LSS follows the FDA suggestion regarding validation, which applies a 'risk-based' approach to systems and electronic records that affect product quality and safety.
CTG's seasoned validation practitioners and business consultants apply extensive industry experience and proven ISO 9001:2000 project management methodologies to a full range of compliance and validation activities across all disciplines, including:
- Custom and COTS IT systems (e.g., LIMS, EDMS, CDMS, spreadsheets)
- Computerized laboratory equipment (e.g., LC/GC, MS, other data acquisition systems)
- Manufacturing and processing systems (e.g., MRP, MES, SCADA, DCS, PLC)
- Facilities and utilities systems (e.g., water purification, HVAC, environmental control, CIP/SIP)
- Infrastructure qualification (networks, servers, computer room environments)
- Creation of computer system validation policies and procedures
- Management consulting services that
establish a risk-based approach to validation
- Development of standard templates for validation documents
- IQ/OQ/PQ planning, development, and execution
- Delivery of validation life-cycle training tailored to client corporate polices
- IT assessments that focus on the complete
IT organization
- Joint technology selection services for assessing commercial
off-the shelf systems and packages
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