Equipment Calibration Software Systems

Equipment Calibration Software Systems by MasterControl Manages Calibration Schedules, Calibration Tasks and Calibration Data for FDA Inspections

A company's equipment calibration tasks are essential to the efficient ebb and flow of quality management and regulatory compliance (FDA, ISO, etc.) processes. MasterControl's equipment calibration software can help management these tasks electronically and provides analytics on the stored data.

Accurate functioning of instruments, apparatus, gauges, and recording devices is critical in the manufacturing and analysis of product. The FDA therefore mandates a written program for the routine calibration of such equipment as well as the retention of calibration records. Besides the obvious quality benefits, equipment calibration system also helps minimize downtime in manufacturing and laboratory operations.

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Product Data Sheet: MasterControl Equipment Calibrationā„¢
Product Data Sheet: MasterControl Equipment Maintenanceā„¢
White Paper: Calibration Software: The Buck Starts at User Requirements
Webinar: AberdeenGroup - The Cost of Quality: a Study on Life Sciences



Integrated Performance of Equipment Calibration Software

In addition to providing streamlined equipment calibration management capabilities, the MasterControl equipment calibration software can also be integrated with the MasterControl Equipment Maintenance solution for streamlined data-to-maintenance process flow.

How Can MasterControl Equipment Calibration Systems Help You?

MasterControl equipment calibration systems manage your calibration schedule and automatically triggers calibration events before they are due. The solution routes calibration tasks containing specific instructions to the appropriate personnel for completion and review. A complete record, including calibration data, is stored for inspection by regulatory agencies or other auditors.

Equipment Calibration Software Validation Services

MasterControl considers validation an integral part of software solutions for FDA-regulated customers. For FDA-regulated companies, MasterControl provides equipment calibration software, several flexible validation offerings and services to meet each company's individual risk requirements for validation. These offerings dramatically cut the time, pain, and cost involved in validation to ensure compliance.

Here's how MasterControl addresses some of the major challenges that companies face in administering a calibration program:

Equipment Calibration System Challenges Equipment Calibration Software Solutions
Disconnected Processes:

When a company uses equipment calibration systems that are not integrated, support costs increase, work is duplicated due to overlapping functionality, and vital information is not linked in a quality context. This results in a loss of efficiency and less control over quality issues.

Connected Processes:

MasterControl equipment calibration software is a part of the MasterControl integrated suite, enabling anything from single-site to global, multi-site implementations. MasterControl collects compliance-related data in a single repository for use in continuous quality improvement.

Lack of Control:

An equipment calibration system depends heavily on the reliability of task creation and reminders. The sheer number of pieces of equipment requiring calibration tasks, even in a moderately-sized program, makes it a challenge to maintain orderly records, avoid missing due dates and incur delays.

Reliability:

MasterControl manages the entire calibration schedule and automatically generates calibration tasks before the due date is reached. Complete records are maintained and advanced reporting capabilities of the equipment calibration software provides insight into calibration activities.

Poor Tracking:

It's time-consuming to physically track paperwork. A manual system makes it almost impossible to identify and avoid bottlenecks.

Automatic Tracking:

MasterControl automates collaboration, routing, follow-up, escalation, and approval of important documentation, removing this as an obstacle of product launch. Using electronic signatures further accelerates the approval process and ensures regulatory compliance.

Features of the Equipment Calibration Software

MasterControl equipment calibration software is an ideal solution for managing calibration programs with the help of the following features:

  • The calibration schedule manages and automatically triggers all calibration tasks.
  • The calibration process, including task completion and review, is automated and overdue assignments can be escalated to supervisors
  • Specific instructions, including measuring parameters, adjustment limits, and failure limits, are administered.
  • Calibration data, including As Found and As Left data, is recorded and stored.
  • Third-party calibration certificates can be imported in lieu of in-house testing within the equipment calibration software.
  • Checkpoints guide participants to initiate further actions, such as failure investigations, requesting a repair and taking the equipment offline if needed.
  • Electronic approval signatures eliminate the need for paper-based records.
  • The analytics reporting tool comes with a standard set of pre-configured reports that can be adjusted and customized by the end user. The solution includes the Calibration History; Current Calibration Tasks; Calibration Tasks Past Due; Failure Incidence By Equipment; Failure Incidence By Task; and Failure Incidence One Year Trend.
  • As with all software developed by MasterControl, the equipment calibration software provides all the features necessary to fully comply with 21 CFR Part 11 requirements. It provides a secure, time-stamped audit trail, reporting, and electronic signature capabilities. Security features include dual passwords for document approval and password expiration, encryption, and certification. MasterControl solutions exceed good business practice requirements for companies that comply with ISO quality standards such as ISO 9000 and ISO 13485.

Additional MasterControl Equipment Calibration Systems Solutions

Instead of managing only partial aspects of quality management, MasterControl's equipment calibration systems are designed to work with "sister solutions" to provide customizable quality system formats within life science and/or high-tech regulated environments.

Contact a MasterControl Representative for Equipment Calibration Software Systems

Contact a MasterControl representative to learn more about MasetrControl's equipment calibration software systems.


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