The medical device industry is under increasing pressure to adhere to FDA rules for process compliancy. Without compliance, these companies are unable to bring products to market and are subject to financial, civil and potentially criminal sanctions.
Along with increasing competition in the market for medical devices and the decreases in available staff, it’s clear why these companies look to effective methods for ensuring compliance with government policy and procedure while decreasing time-to-market and increasing competitiveness.
FDA 21 CFR Part 820 is a set of regulatory rules laid out by the U.S. Food and Drug Administration (FDA) for the purpose of ensuring the adequacy of quality systems involved in the manufacture of pharmaceutical products and medical devices. Unlike Part 11 Compliance, Part 820's GMP regulations are mandatory for all medical device companies.
SoftExpert offers the most advanced and comprehensive software solution for compliance management that meets the stringent needs of the FDA 21 CFR Part 820. SoftExpert Excellence Suite helps companies follow the regulation, while lowering the costs of compliance, maximizing success, increasing productivity and reducing risks.
SoftExpert’s solutions enables organizations to easily follow FDA 21 CFR Part 820, providing resources to manage processes, audits, risks, calibrations, maintenance, projects, quality records, boosting organizational efficiency, reducing rework and waste. With online collaboration capabilities, organizations and managers can communicate and be updated on the continuous improvement initiatives, involving more users, teams, offices and business units with a systematic and unified approach, turning quality guidelines into actions.
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- Employ industry-proven solution that is seamlessly integrated.
- Reduce the cost involved to comply with FDA regulations.
- Increase end user acceptance and productivity.
- Monitor and report product defects.
- Automate the required regulatory data collection of device-history records.
- Manage product complaints and adverse events.
- Modify procedures to suit unique business requirements.
- Access procedures while maintaining complete document security.
- Maintain complete audit trail records.
- Manage product specifications.