News - Equipment Calibration and Maintenance Systems
MasterControl™ Releases New Equipment Maintenance and Equipment Calibration Software Systems
SALT LAKE CITY July 19, 2007 - MasterControl Inc., a global provider of GxP process and document management software solutions for life science companies, today announced the release of two new products, MasterControl Equipment Maintenance™ and MasterControl Calibration™.
“Equipment maintenance and calibration are two crucial activities on a production line,” says MasterControl Product Manager Oliver Wolfe. “Regulated environments create unique demands on manufacturing departments which struggle to meet efficiency goals as well as quality demands. These two new solutions can help integrate quality management across a manufacturing environment.”
MasterControl Equipment Maintenance manages maintenance schedules 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.
MasterControl Equipment Calibration handles 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, these two new solutions provide all the features necessary to fully comply with 21 CFR Part 11 requirements. They provide 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.
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.