Manage compliances with LuitBiz DMS

In all business operations regulatory compliance has a huge impact. Companies spend a lot of time and money in meeting regulatory compliances but a single flaw in their systems can have huge repercussions and might call for huge fines. LuitBiz DMS helps organizations meet the following regulatory compliances:

FDA 21 CFR Part 11 Compliance

Required By: All drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries

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FDA 21 CFR PART 510(k) & 820 Compliance

Required By: Domestic & foreign manufacturers and specification developers introducing a device to the U.S. market and repackers or relabelers of medical devices

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Financial Industry Regulatory Authority (FINRA) Compliance

Required By: Broker-Dealers, Capital Acquisition Brokers, and Funding Portals in USA

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GDPR Compliance

Required By: All Companies that collect data from citizens in European Union (EU) countries will need to comply with GDPR rules for protecting customer data by May 25, 2018.

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GMP Compliance

Required By: All manufacturers, processors, & packagers of drugs, medical devices, some food, & blood

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Gramm-Leach-Bliley Act (GLBA) Compliance

Required By: All financial institutions engaged in banking, insuring, stocks and bonds, financial advice & investing in USA

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HIPAA Compliance

Required By: All health plans, health care clearing houses, and to any health care provider who transmits health information in electronic form

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ISO 9001 2015 Compliance

Required By: All organizations, regardless of size or industry, that want to show their ability to meet customer requirements and regulatory obligations

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NIOSH 42 CFR Part 84 Compliance

Required By: Any company that designs, manufactures, assembles, or controls the assembly of a respirator & seeks NIOSH certification

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OSHA Compliance

Required By: Private sector workers, workers in the state and local governments and federal government employees in USA

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Sarbanes-Oxley (SOX) Compliance

Required By: All publicly traded companies in the United States as well as wholly-owned subsidiaries and foreign companies that are publicly traded and do business in USA

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SEC Compliance

Required By: All organizations that work or operate in the securities industry, including brokers, investment advisers and companies, municipal advisers, mutual funds, and the members or participants of Systems Compliance and Integrity entities

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