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For life science companies, 21 CFR Part 11 compliance has always been a challenge. While using a cloud-based quality management system helps streamline compliance processes by allowing for digital signatures, organizations must be sure to tick all the boxes when it comes to complying with stringent FDA guidelines.

 21 CFR Part 11 is an FDA guidance that sets out how organizations operating in the United States can use electronic records and digital signatures in their quality management systems to replace paper-based documents and “wet signatures”. Put simply, any organization that uses quality management and needs to conform to FDA regulations, such as pharmaceutical and life sciences organizations, should be aware of 21 CFR Part 11 and its requirements.

 WCCS empowers small to mid size companies with fractional and on demand compliance consulting and expertise.

Key Factors Relating to Title 21 CFR Part 11

For any businesses concerned about their compliance with this article, there are seven key considerations. In most cases, it is cost-effective to hire a managed IT service to remain compliant.

Does Your Business Need to Be Compliant?

Unless your business has strictly adhered to a 100% paper-based policy for its entire existence, you’re likely subject to Title 21 CFR Part 11 compliance. While the exact wording within the document may be intimidating, it’s intended to create a safer and more secure digital space. What’s more, Part 11 compliance benefits your business as it creates a more streamlined and advanced paperless system.

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The best approach to ensuring compliance is to hire a professionally managed IT service to handle regulatory requirements. At West Coast Computer Solutions, we specialize in web security services, ensuring clients are fully compliant with regulations. Based out of California, some of the services we offer include:

Whether you’re a life science business that requires San Diego IT services or managed IT in Temecula or Murrieta, give us a call today. Our team is focused on delivering premium and customized solutions to small and medium businesses. 

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