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Calibration Module
To ensure consumer and workplace
safety, manufacturing companies
must closely monitor and regulate
their equipment and processes. This
is particularly important in industries
such as pharmaceuticals, oil & gas,
nuclear, energy, and consumer
products where failure to meet regulatory requirements
can not only delay getting products to market, but can
also result in fines, plant closings, and lost revenue.
Calibration of the equipment, instruments, and
processes used in manufacturing is essential in
achieving the high-level of precision required by
regulatory agencies like the Food and Drug
Administration (FDA) and the International Organization
for Standardization (ISO). The FDA’s submission
guidelines for pre-market notifications require
companies to document how they perform, trace, and
achieve consistency with equipment and instrument
calibration. This documentation helps companies
meet current good manufacturing practices (cGMP)
for quality and safety.
Calibration Tools Unmatched in the Industry
Working with highly regulated industries such as
pharmaceuticals, oil & gas, and others, Mainsaver has
calibrations knowledge and experience in a variety of
industries to help companies meet the stringent
monitoring standards of regulatory agencies. In addition, Mainsaver has capabilities based on input from customers to provide a complete, compliant solution for calibration. Customers no longer have to maintain two separate systems—one for EAM and another for calibration—enabling them to save administrative and training costs.
Traceability – Traceability is critical for best practices
in calibration management. If a calibration standard is
found to be incorrect, Mainsaver allows users to
quickly determine which instruments were miscalibrated.
Identifying the standard’s last "good"
calibration is critical to effectively segregating potentially
affected products. The Mainsaver Calibration
module allows users to perform this reverse traceability.
Tracking Calibration Results – Proper calibration
procedures require tracking calibration results and
variances between actual condition and standards
established by the manufacturer, international
standards, or internal best practices.
Calibration records must show proper resolution or
degree of accuracy for the results. Mainsaver tracks
results, including calibration sequences, test point data,
tolerances, process control limits, "As Found" results,"As Left" results, action taken, and calibration status.
The calibration work order is linked to a particular piece
of equipment, allowing for easy cost roll-up and
historical tracking of all equipment information based
on parent equipment, department, or organization.
Mainsaver also tracks corrective action procedures
and root-cause analysis related to out-of-tolerance
work orders.
Calibration History and Reports – Each time a user
performs a calibration, Mainsaver automatically
stores the data. Mainsaver customers can search
and view all calibration results for a selected piece of
equipment by equipment class, department, or
date range.
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