Houston, TX November 4 - 5, 2010
Marriott - West Loop South Galleria
Details and RegistrationHouston, TX November 3, 2010
Marriott - West Loop South Galleria
Details and RegistrationGateway Consulting Group, Inc.
8610 Transit Rd. Suite 100
East Amherst, New York, 14051
Email: info@gatewaygroup.com
Call: 800-668-2334
Fax : 716-204-3378
We have served the Fortune 100 since 1991, implementing enterprise content management and product lifecycle management systems that deliver exceptional value, functionality, and competitive advantage.
We are staffed by a team of very experienced information technology professionals that understand the business processes within highly regulated manufacturing environments. We deliver robust information management solutions for mission-critical operations.
Medical Device and Pharmaceutical manufacturers are a major focus for our consulting practice. Gateway has been frequently engaged to develop information management strategies to improve the efficiency and effectiveness of business processes in FDA regulated industries.
Gateway's information technology professionals are highly qualified to implement either Product Lifecycle Management (PLM) or Enterprise Content Management (ECM) solutions in support of the applicable ISO standards and FDA regulations:
Validation is necessary to ensure an ECM or PLM system is working properly, and provides correct information to assist an organization in designing and manufacturing products that are safe and effective.
Validation is also required for ECM or PLM software that is used in the quality system, including any customizations created internally or by outside consultants.
Gateway has developed a framework for creating the documented evidence required by medical device manufacturers to comply with both the technical and procedural aspects of the FDA 21 CFR Part 11 and 21 CFR Part 820. including reports for:
Reference accounts for ECM and PLM projects conducted by Gateway Consulting Group include: