PRZOOM - /newswire/ -
Salt Lake City, UT, United States, 2016/09/14 - MasterControl, Inc. announced the establishment of a partnership with SDLC Business Solutions, a good manufacturing practices (GMP) consultancy firm in Mexico - SDLC-BS.com.mx / MasterControl.com.
MasterControl, Inc., a leading global provider of quality management software solutions and services, today announced the establishment of a partnership with SDLC Business Solutions, a good manufacturing practices (GMP) consultancy firm in Mexico. SDLC's primary focus is to bring its knowledge and expertise to help organizations align their compliance goals with quality regulations like Mexican Official Standards NOM-059, NOM-164, NOM-220, NOM-240, and NOM-241 as well as globally recognized standards such as FDA 21 CFR Part 11 and FDA CFR Part 210 and 211.
"SDLC brings extensive compliance and quality management consulting experience that represents a significant benefit to MasterControl and our global expansion efforts," said Michael Bothe, MasterControl SVP Sales and Partner Operations. "SDLC offers specialized, well-regarded services that go hand-in-hand with MasterControl's approach to quality management."
SDLC offers services in the following areas:
• Validation of computer systems;
• Consulting for and preparation of GMP audits;
• Supplier audits;
• Conformation and/or review of dossier implementation;
• System implementation and improvement of system quality management;
• Annual review of product creation framework system;
• Corrective and preventive action (CAPA) system implementation;
• Risk analysis;
• Deviations, noncompliance, and out of specifications (OOS).
About SDLC Business Solutions S. de RL de CV
Founded in 2007, SDLC Business Solutions (sdlc-bs.com.mx) offers consultancy services to help clients achieve and maintain compliance with global good manufacturing practices (GMP). The firm helps pharmaceutical and other life science companies face challenges such as issues related to the manufacture and/or import of medicinal products intended for human use and/or for the research, laboratory quality control, storage, and the distribution of medicines and raw materials for processing.
MasterControl, Inc. (mastercontrol.com) produces software solutions that enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company's critical information throughout the entire product lifecycle. MasterControl software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions include quality management, document management, product lifecycle management, audit management, training management, document control, bill of materials, supplier management, submissions document management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl software provides our customers with a complete information management solution across the entire enterprise. For more information about MasterControl call 1.800.825.9117 (U.S.); +44 (0) 1256 325 949 (Europe); +81 (03) 5422 6665 (Japan); or +61 (3) 9717 9727 (Australia).