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Customer Story
Life Sciences Manufacturer Leverages Experitec’s Instrument Technicians and Expertise
To Meet cGMP Compliance
Instrumentation Expertise Enables Customer to Speed Up Their Turnaround With Confidence
SITUATION
To meet FDA cGMP regulations, this Life Sciences customer performs semi-annual shutdowns to calibrate and maintain its 450-500 measurement devices installed throughout their process facility.
To minimize downtime during the turnaround process, Experitec provides five instrumentation technicians to assist their plant personnel. Our ability to test & calibrate a wide array of devices, regardless of manufacturer, helps ensure the plant starts back up on time and is in compliance. As part of our Scope of Work, Experitec provides full documentation of as-found, as-left data for each of their devices to ensure full traceability for their quality & reporting requirements.
SOLUTION COMPONENTS
Expertise: 5 technicians on-site for 5 full-days
Equipment: Calibration devices used to validate instrumentation are verified according to ISO 17025 Standards
Documentation: Calibration records are created in accordance with the customer’s record keeping requirements
RESULTS
Meets FDA Requirements using Experitec technicians
Speeds up turnaround time
Enables customer to minimize hiring and training
Provides full traceability documentation
The Experitec Difference
Premier Service Provider
We have the technical expertise, experience and understanding of how your measurement systems are supposed to perform.
Experience
All technicians used on this outage had previous experience with Life Science outages, ensuring processes & documentation met customer requirements.
CUSTOMER BENEFITS
The customer minimizes the total outage time length and can restart production knowing they are fully in compliance with FDA requirements for instrument validations.
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