MasterControl Equipment Calibration™ - Software System

Software to Manage Calibration Schedules, Calibration Tasks and Calibration Data for FDA Inspections

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, such a program also helps minimize downtime in manufacturing and laboratory operations.

How Can MasterControl Equipment Calibration Help You?

MasterControl Equipment Calibration manages 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.

Validation Services™
MasterControl™ considers validation an integral part of software solutions for FDA-regulated customers. For FDA-regulated companies, MasterControl provides 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 Challenges		MasterControl Equipment Calibration Software System Solutions
Disconnected Processes: When a company uses tools 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 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: A calibration program 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 provide 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 DHF Express automates collaboration, routing, follow-up, escalation, and approval of important design control documentation, removing this as an obstacle of product launch. Using electronic signatures further accelerates the approval process and ensures regulatory compliance.

Summary of Features: MasterControl Equipment Calibration 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.
• 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 solution 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.

About MasterControl
MasterControl Inc. is a global provider of GxP process and document management software solutions for life science companies. The MasterControl™ suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better process management. For more information, visit www.mastercontrol.com, or call 800-825-9117.