VigilEnt Policy Center - FDA Content Module
VigilEnt Policy Center FDA Content Module provides comprehensive, automated processes that make it easier for pharmaceutical, biotech and medical device companies to comply with the requirements of the FDA 21 CFR Part 11 regulation. The FDA Module automates processes for improving regulatory policy, training and reporting compliance across your enterprise. This promotes regulatory compliance while saving time and money. Developed in conjunction with regulatory experts, the FDA Module enables your organization to streamline, improve and maintain compliance with information security requirements.
Key Benefits
- Improves your organization's FDA compliance. Provides a summary of FDA security regulation 21 CFR Part 11 with links to the regulation's text. Includes an analysis of key issues your organization must address in order to achieve compliance.
- VigilEnt Policy Center FDA Library
- Protects against incomplete compliance. Includes a gap analysis checklist that helps determine what important policies are not included in your security program, enabling you to improve your electronic records and electronic signatures security program to meet the 21 CFR Part 11 regulation. A self-assessment questionnaire enables you to measure and report your organization's level of compliance for each business unit across the enterprise.
- Improves staff awareness and compliance. Supplies quizzes that test the knowledge of executives, security managers, security staff, security coordinators and other individuals who are directly or indirectly responsible for planning, implementing and monitoring the security program. Awareness assessments also test employee knowledge of 21 CFR Part 11 security regulations, including employees' understanding of specific policies.
- Helps your organization meet regulatory examination requirements. Provides a complete process across your enterprise to align the security program with the requirements and expectations of examiners and auditors. The module's regulatory guide and policy links offer quick reference to the regulation. In addition, VigilEnt Policy Center's reporting features help you centralize and easily deliver pertinent information requested by FDA examiners.
