Software for Manufacturing Regulatory Compliance
The aim of addressing the manufacturing regulatory compliance challenge involves establishing a consistent, top-down strategy across the manufacturing enterprise. Software solutions for Manufacturing Execution and Quality Management tailored to the needs of Medical Device and Pharmaceutical manufacturers address these challenges.
This system enables compliance with 21 CFR Part 11, and provides a comprehensive technology infrastructure for manufacturers, effectively reducing associated costs and risks. It enables automation of manufacturing processes, creating a paperless environment for global regulatory-compliant operations, and allowing companies to maintain compliance with good manufacturing practices more efficiently and cost-effectively.
Regulatory compliance software assists global manufacturers in delivering high-quality products consistently. Through real-time visibility, enforcement of manufacturing controls and integrating feedback into product design, the platform naturally promotes global compliance. Additionally, it drives risk-based compliance management globally by fostering operational excellence and ensuring compliance with international regulatory and industry standards as a by-product of efficient, high-quality processes.
Features of regulatory compliance software:
- FDA Regulatory Compliance with 21 CFR Part 820, Parts 210/211 and 21 CFR Part 11 for electronic records and electronic signatures.
- Compliance with international industry standards including ISO 9001, ISO 13485, IEC 61215 and IEC 61646
- Enterprise alignment with Good Manufacturing Practices (GMP) and Guaranteed Performance Standards
- Reduction in Audit Findings and risks associated with non-compliance
Regulatory compliance software functionality
An effective quality compliance software solution is adaptable to existing company processes. Regulatory compliance management software integrates control functions and responsibility structures to enable a fast and effective flow of information. This results in quick identification of production trends and operational risks and the avoidance of negative consequences.
Compliance software integrates user administration to enable reliable role and function allocations for each individual user. To meet all organizational compliance needs, compliance management software must provide a highly configurable and scalable solution and create no sector restrictions. As a compliance document software solution, compliance software must support a large variety of different document types, different rights and different workflows. Compliance software should be useful to every unit within an organization, regardless of location.
Specific functionality supported by an integrated compliance software solution includes:
Training and qualification - Regulatory compliance software provides a single repository for employee training and certification, including employee training profiles, course information, job requirements, certification expiration dates, and revised training requirements.
Assessments - Compliance software enables auditing processes, including scheduling, creation, and online execution.
Calibration and preventive management - Compliance software creates schedules and offers notifications, alerts, and escalation for all calibration and equipment maintenance activities.
Supplier management - Compliance software manages supplier assessments and evaluations, identifying issues and moving them to resolution.
Environmental management - With compliance document software, manufacturers ensure complete environmental recordkeeping, including analysis of environmental aspects and impacts and tracking of environmental targets and objectives.
Occupational health and safety - Compliance management software tracks and addresses workplace incidents, monitors safety hazards and controls, and manages policies and records.
Risk management - Compliance software helps manufacturers assess and mitigate risks using thorough risk analysis and controls testing.
