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To provide medical device manufacturers with the tools needed to comply with the electronic records and signatures requirements indicated in US Food and Drug Administration (FDA) Regulation 21CFR Part 11, so as to help manufacturers shorten their time to market and increase their revenues.
Product overview
SMARTEAM FDA Compliance provides companies with a much-needed competitive advantage: the tools needed to comply with the requirements of US Food and Drug Administration (FDA) Regulation 21CFR part 11 for electronic records and signatures. Implementation of SMARTEAM FDA Compliance involves defining an organizations specific procedures and needs, so as to achieve an FDA compliance solution tailored to the organization.
Product Highlights
- Windows - based collaborative Product Data Management solution for medical device and related manufacturers
- Enables companies to comply with FDA 21CFR Part 11
- Enhanced user security mechanism, for authenticating product records
- Audit trail of changes generated electronically and accessible instantly for review
- Full handling of electronic signatures to authorized users
- Automated and standardized workflow processes provide required sequence of operations
- Automatic mail notifications to administrators upon failed logins to the system
- Batch printing with embedded electronic signature information
- System documentation
- FDA compliance components
Product Key Customers Benefits
Meets organizations needs with regard to FDA regulatory compliance:
- Helps organizations be compliant with regard to FDA 21CFR Part 11
- Helps organizations avoid FDA warnings, delays, and fines related to the development cycle, through built-in, compliant best practices mandated in FDA 21CFR Part 11
- Is an open system, as stipulated in the Part 11 requirements
- Manages all information required by the FDA in the SMARTEAM database
- Is easily accessible and instantly presentable to the certifying agency
In addition to providing regulatory benefits, SMARTEAM - FDA Compliance:
- Provides a collaborative Product Data Management solution
- Leverages industry-leading SMARTEAM PDM tools with the full scope of information regarding medical device manufacturing and regulatory compliance
- Facilitates innovation and collaboration between product engineers and across the extended enterprise, allowing companies to track, monitor, and review the complete history of drawing revisions and design documents
- Optimizes and accelerates the development process, shortening: Time to submission
Time to approval
Time to volume
- Integrates tightly with existing multi-CAD and ERP systems
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