> PCI Named to Fast 50 by Triangle Business Journal
> 2011 PCI/Todd McCulloch Memorial Golf Classic raises money for American Heart Association - Sept. 28, 2011
> PCI's Mike Cable elected ISA Chapter President - August 24, 2011
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> Calibration Software Validation Philosophy / GAMP 5 and Risk-Based Validation - By Jim Bufano, Mike Cable and Todd McCulloch (PCI Consultants)
> Equipment Relocation Project
> Equipment Qualification
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While working at a previous vaccine manufacturing facility, I established a long standing relationship with PCI. They were very instrumental in training the staff on pertinent software, as well as defining compliance issues. In the Pharma industry, Quality Systems are an industry/business requirement. PCI was instrumental in the development of our staff as well as our own Quality System approach and platform.
- Maintenance Manager, Northwest Biopharmaceutical Manufacturing Facility
PCI's Data Analysis Services offers FDA regulated companies with a full range of data analysis services from critical database management to custom report writing to analysis of calibration, preventive maintenance, and predictive maintenance results which allow our customers to make better business decisions relative to cost controls, compliance, and equipment lifecycle.
PCI is a Blue Mountain Regulatory Asset Manager system user and our experience with most major maintenance & calibration systems including MaximoPro, SAP PM, Datastream EAS, and ProCal.
PCI offers many types of services such as database management and data analysis services. Our Data Analysis team provides ongoing support as well as short term project support. Our project services include database audits, GAP analysis, system upgrades, new system implementations and the activities that support these projects such as data migration planning, data cleansing, record retention planning, and archiving controls.
With our report writing expertise, our team can provide the following types of performance monitoring for FDA regulated companies:
- Maintenance & Calibration activities planning
- Dashboard Key Performance Indicators (KPIs) development
- Trend for Equipment Failures (Failure MODE Analysis)
- Calibration Interval Reduction Analysis
