SMARTEAM Regulatory Compliance Framework (RCF)
To provide a working environment that accelerates the process by which organizations verify their compliance to industrial regulations, such as FDA - 21 CFR Part 11.
Product Overview
Product Highlights
Product Key Customer Benefits

Product Overview

SmarTeam Regulatory Compliance Framework provides companies with tools to ensure and facilitate
  • Management of access authorization within the working environment
  • Database traceability
  • Electronic signatures within approval processes

SmarTeam Regulatory Compliance Framework enables:

  • A collaborative PLM solution for various industrial markets, both Windows and Web based environments
  • Accelerated compliance with industry-specific regulations , such as FDA - 21 CFR Part 11
  • Process-driven digital signoff with Electronic Signatures
  • Audit Trail - full tracking and querying of system activities
  • Automated and standardized workflow processes
  • Enhanced security Built-in controls for strict authentication
  • Automatic mail notifications
  • Batch printing

Product Highlights

  • Supports Web and Windows
  • Enhanced user security mechanism, for authenticating product records
  • Audit trail of changes generated electronically and accessible instantly for review
  • Comprehensive and flexible handling of electronic signatures for authorized users
  • Automatic mail notifications
  • Batch printing with embedded electronic signature information
  • Streamlines the regulatory compliance approval process

Product Key Customer Benefits

Supports organizations needs for compliance with certain industry-specific regulations by:
  • Helping organizations to avoid regulatory warnings, delays, and fines related to the development cycle, through built-in best practices that may be applicable to their compliance.
  • Being an open system, in accordance with certain industry requirements
  • Manages general and secured data in the SmarTeam database
  • Is easily accessible and instantly presentable to the certifying agency

In addition to providing the regulatory benefits described herein, SmarTeam - Regulatory Compliance Framework:
  • Provides a collaborative Product Data Management solution
  • Leverages industry-leading SmarTeam PDM tools with the full scope of information regarding compliance with industry-specific regulations.
  • 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 production
  • Integrates tightly with existing MS Office and multi-CAD systems