SALT LAKE CITY - October 4, 2005 -MasterControl Inc. today announced that Strides Inc., a manufacturer of dietary supplements and developer of pharmaceutical products, has chosen the MasterControl software solution to integrate its quality processes and facilitate FDA compliance.
Meeting FDA's 21 CFR Part 210 requirements is labor-intensive and time-consuming with the company's current paper-based system. "We want control in revision of SOPs; tracking of documents, training requirements, and deviations; and in closing out the CAPA (Corrective Action and Preventive Action) loop," said George T. Lopac III, Manager QA Compliance for Strides.
The company, based in Somerset , N.J. , considered two other software providers before making a decision. "MasterControl offered the best of both worlds - reasonable cost and great functionality," said Lopac.
Strides plans to implement a fully integrated MasterControl quality management system, consisting of MasterControl Documents™, MasterControl CAPA™, MasterControl Forms™, and MasterControl Training™ to help manage thousands of documents and streamline numerous quality processes. MasterControl promotes efficiency throughout the enterprise by interconnecting people (regardless of location), data, and processes under a single Web-based platform.
FDA's 21 CFR Part 11 requires complete data and system security for electronic record-keeping systems and also mandates full-cycle validation of the system. Strides plans to validate its system with the help of MasterControl's Validation ToolKit, which provides a detailed, pre-written IQ (installation qualification) and OQ (operational qualification) validation test protocols and scripts. MasterControl's comprehensive validation services also include full-cycle validation to help with PQ (performance qualification).
MasterControl Inc., based in Salt Lake City , has been at the forefront of providing innovative electronic quality management systems since 1993. MasterControl provides a configurable, easy-to-use, and integrated system to help companies effectively manage change control, training control, audits, corrective/preventive action (CAPA), and other forms-based quality processes under a single Web-based platform. The company offers comprehensive technical and customer support, including product training, installation, implementation, and validation services. Over 400 companies worldwide use MasterControl to comply with FDA regulatory requirements and ISO quality standards.