Enzyme
Enzyme is a healthcare IT company based in San Francisco, offering a 21 CFR Part 11 compliant quality management system (QMS) and consulting services to aid life science companies in FDA approval and compliance.
Locations
Enzyme is based in San Francisco, CA, USA, with an option for remote work. This setup allows the company to leverage a wide talent pool and service clients across multiple regions including the United States and Canada. The company operates fully remotely as well, adapting to the modern, flexible work environment.
Industry and Sub-Industry
Enzyme is positioned within the Healthcare industry, specifically focusing on Healthcare IT. Its mission is to innovate and streamline the compliance and regulatory processes for life science companies. Enzyme offers a range of solutions that address the intricate needs of the healthcare sector, supporting companies from product development through to market launch.
Services
Enzyme provides an online quality management system (QMS) software that is 21 CFR Part 11 compliant and validated out-of-box. The company offers supportive QA/RA consulting and helps life science companies with FDA approval and ongoing compliance. Enzyme's services support the full product lifecycle and include various plans tailored to different organizational needs. Additionally, Enzyme integrates seamlessly with existing tools, allowing for easy data import and report generation. The company has recently added Microsoft Office 365 integration to its suite of tools.
Notable Clients
Enzyme is trusted by a diverse range of companies within the life sciences and healthcare industries. Some notable clients include Pfizer, Roche, Stryker, Genentech, Avails Medical, Click Therapeutics, The Flex Company, Akyrian, Cari Health, Cateva Solutions, Clearcam, Emboline, Empo Health, Evidation, Hannah Life Technologies, Innovate Calgary, Limbix, Lokavant, NeuraStatis, npower, Overjet, Sebela, Spire Health, and Vaxess.
Accreditations and Compliance
Enzyme holds several industry certifications, demonstrating its commitment to high standards and regulatory compliance. The company is ISO 9001:2015 certified and SOC 2 Type II compliant. These certifications reflect Enzyme's dedication to quality management and data security, ensuring that clients can trust Enzyme's services and software to meet stringent industry regulations.