Food and pharmaceutical products have significant impact on the wellbeing of consumers.
The US Food and Drug Administration (FDA) has adopted a risk-based approach to establish
and enforce regulations for manufacturing and quality assurance for these products.
Mandatory regulations (e.g., current good manufacturing practices or cGMP and 21
CFR Part 11) are defined to ensure final product quality through proper design,
analysis, and control of manufacturing operations. For regulated operations, traditional
methods of paper-based signoffs and track & trace are error prone and could significantly
TrakSYS makes effective regulatory compliance a reality. Without disrupting operations,
TrakSYS centralizes electronic signoff, workflow management, visibility, and reporting
throughout production and quality processes. Whether it's cGMP, hazard analysis
and critical control points (HACCP), electronic batch records (EBR), ISO 22000,
FDA Bioterrorism Act of 2002, safe quality foods (SQF) or others, TrakSYS offers
regulatory compliance and safety as an integral part of its comprehensive operations
TrakSYS Value in Regulatory Compliance
- Leverage existing infrastructure (independent of vendors/suppliers, vintage)
- Manage and execute proper workflow for electronic signoff
- Enable compliance with track & trace requirements
- Establish comprehensive electronic production records
- Improve reporting accuracy, consistency, and completeness
- Reduce cost of compliance
Learn more about TrakSYS.