Consulting

PCI has the expertise required to support clients in the development and implementation of a Calibration and Maintenance Program. PCI can identify and implement software for the scheduling of critical and non-critical activities.

PCI provides cGxP calibration training as well as other services including:

• Calibration Program Development & Management
• Calibration Program Audits
• Maintenance Program Re-engineering to increase compliance, operational efficiency and reduce cost
• Blue Mountain Regulatory Asset Manager software setup, validation, and user training
• Blue Mountain's Calibration Manager support
• Impact assessments of other facility systems on your Calibration and Maintenance programs
• Calibration and Maintenance SOP & Policy Development

Our Consultants are:

• Experienced with cGMP/cGLP and Industry Best Practices
• Knowledgeable with GAMP Calibration Guidance & ISPE's Baseline Guides
• Well Versed in ISO 17025 Requirements
• Qualified to implement, configure, validate, and train customers on Blue Mountain's Regulatory Asset Manager software
• Experience with Program setup in other software including Maximo, SAP, and Infor EAM (formerly Datastream 7i)

Let us develop a Calibration Program Management Plan for your company to help you optimize your assets. Tracking the location, providing at-a-glance detailed service history, ensuring timely scheduled service, and routinely analyzing maintenance costs for all assets site wide are the elements of a PCI developed Calibration Program.

Our Calibration Program Management Services reduce total cost of ownership by:

• Maximizing equipment utilization - Increasing instrument runtime
• Providing documented evidence of maintenance events for cGxP compliance
• Assuring you do not pay for service for unused equipment
• Managing your maintenance contracts