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- Readily meet ISO and FDA compliance

Autoscribe’s Instrument Calibration and Management System (ICMS) enables companies to readily and cost effectively meet their regulatory compliance requirements eg FDA, ISO 9000 and ISO 17025.

The latest version of Autoscribe’s ICMS includes electrical safety checking in addition to calibration and maintenance. Instrument systems (e.g. HPLC) can be linked to components (e.g. detector, pump, etc) which can be individually managed.

Any ODBC compliant reporting tool can be used to develop your own reports eg Business Objects Crystal Reports.

Autoscribe's Instrument Calibration and Maintenance System is a convenient and easy way to maintain all of your records on the instrumentation and equipment in your laboratory and / or your company. ICMS can be supplied as a standalone product or as an integral part of Matrix LIMS. Furthermore it can be supplied as an ‘out of the box solution’ or as a fully configurable COTS package that can be integrated with other systems.

ICMS is a useful utility in any environment and especially useful for maintaining compliance with regulatory standards.

ICMS provides:

· Automated reminders of pending maintenance, calibration and electrical safety test tasks
· Ensures that instruments / equipment are valid and available
· Allows assessment of support agreement value by keeping full records for each instrument
· Saves time by automatically comparing entered calibration data with pre-set limits
· Provides immediate feedback on instrument availability
· Facilitates Regulatory Compliance

ICMS holds and reports on three classes of important information:

Instrument Inventory
Information relating to each piece of equipment such as code, description, class, serial number, model number, manufacturer, supplier, location, date of purchase, etc.

Calibration
Calibration intervals may be set by time or usage. All calibration activities can be recorded and checked against calibration limits. Out of limit results are flagged and the instrument status can be changed to unavailable. Comments may be entered to explain results or actions.

Maintenance
Scheduling of routine maintenance intervals may be managed according to manufacturer recommendations. Faults, breakdowns and non-routine operations can be recorded. Comments may be entered for each event and maintenance costs can be entered and tracked.

Several standard screen views and printed reports are included such as:

  • Instrument inventory listing with calibrations, maintenance or electrical safety test schedules
  • A list of all instruments due for calibrations, maintenance or electrical safety tests within X days
  • Overdue calibrations, maintenance or electrical safety tests
  • The entire maintenance log for any instrument
  • Non-routine maintenance logs.

ICMS is fully version controlled, audit trailed and meets FDA 21CFR11 requirements.


NOTE: This item is from our 'historic' database and may contain information which is not up to date.

Source: Autoscribe Ltd. View latest company information

Posted: August 19, 2005
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