MasterControl Equipment Maintenance™ - Software System

Software to Manage Equipment Maintenance Schedules and Maintenance Tasks 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 the MasterControl Equipment Maintenance Software System Help You?

MasterControl Equipment Maintenance manages your maintenance schedule and automatically triggers maintenance tasks before they are due.  The solution routes tasks containing specific instructions to the appropriate personnel for completion and review. A complete record, including captured information, is stored for inspection by regulatory agencies or other auditors.

Equipment Maintenance Software System Validation
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 validation and risk requirements.  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 maintenance program:

Equipment Maintenance and Preventive Maintenance Challenges		MasterControl Equipment Maintenance Software System Solution
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 Maintenance 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 maintenance program depends heavily on the reliability of task creation and reminders. The sheer number of equipment pieces with their associated maintenance tasks, even in a moderately-sized program, makes maintaining orderly records a challenge.		Reliability: MasterControl manages the entire maintenance schedule and automatically generates preventive maintenance tasks before the due date is reached. Complete records are maintained. Advanced reporting capabilities provide insight into maintenance activities..
Poor Tracking of Paperwork: It's time-consuming to physically track paperwork. A manual system makes it almost impossible to identify and avoid bottlenecks.		Automatic Tracking: The system tracks all routing information and data entered into the electronic form, allowing a program manager to identify bottlenecks and understand the sequence of events during processing.

Summary of Features: MasterControl Equipment Maintenance is an ideal solution for managing maintenance programs with the help of the following features:

• The maintenance schedule manages and automatically triggers all preventive maintenance tasks.
• Corrective maintenance can be requested manually as a work request by personnel.
• The maintenance process, including task preview, completion, and review is automated and overdue assignments can be escalated to supervisors.
• Specific instructions, including spare parts lists and required equipment lists, are created during schedule setup.
• Maintenance data, including instrumentation used and observations, are stored as a permanent record.
• Third-party materials can be imported to supplement internal data.
• Checkpoints guide participants to initiate further actions, such as failure investigations, or taking the equipment offline as needed for re-qualifications and recalibrations.
• Electronic approval signatures eliminate the need for paper-based records.
• An 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 customizable reports including Maintenance History; Current Maintenance Tasks; Maintenance Tasks Past Due; and Corrective Maintenance by Cause.
• As with all software developed by MasterControl, the Equipment Maintenance software system provides all the features necessary to 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.