PCI
PCI LLC
NEWS
What our clients say...

PCI redesigned our Calibration Program for compliance and at the same time allow us to recognize long term operation savings by taking a practical approach, rather than an overly conservative approach.

- QA Director, Midwest Biotech R&D and Manufacturing facility
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
PCI, LLC
Customer Focused. Experienced. Knowledgeable.
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