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Autolomous Industries is an innovative biotechnology company located in London that specializes in manufacturing pragmatic digital solutions for cell and gene therapy. The company’s flagship software platform, autoloMATE®, is a cloud-native enterprise-level software platform designed to provide end-to-end solutions for advanced therapies/vector/CGT manufacturing activities, focusing on the manufacturing process itself while seeking to integrate with other support systems. In this article, we’ll take a closer look at Autolomous and how it’s revolutionizing the advanced therapies manufacturing industry.
The Power of autoloMATE®: Streamlining Cell and Gene Therapy Manufacturing Processes
The market for cell and gene therapies is growing rapidly, and it presents unique manufacturing challenges that require new innovative solutions. Autolomous’ flagship software platform, autoloMATE®, is designed to meet these challenges head-on by offering advanced solutions that streamline the entire manufacturing process. This platform enables resource scheduling, management of electronic batch records, insights reporting, as well as review and release activities, all in one place. AutoloMATE® is flexible and can be configured to meet the needs of unique workflows, whether it’s a small biotech startup or a large pharmaceutical company.
ISO Certifications: A Mark of Quality and Security
Autolomous Industries is committed to providing its clients with only the highest quality digital solutions that meet security standards. That’s why the company has achieved ISO certifications across several standards – ISO 27001:2013 (information security), ISO 9001:2015 (quality management), and ISO 14001:2015 (environmental management). These certifications demonstrate Autolomous’ commitment to quality, data security, environmental protection, and continuous improvement.
Compliance with FDA, EMA, and MHRA Regulations
AutoloMATE® has been designed to comply with US FDA, EU EMA & UK MHRA guidance and aligns with the GAMP5 methodology. This ensures that Autolomous’ software is developed and maintained in a manner that meets the highest standards for pharmaceuticals, medical devices, and biologics. Compliance with these regulations is necessary to ensure patient safety, product quality, and reputation.
Conclusion: Digitized Solutions for Advanced Therapies Manufacturing
Autolomous Industries is pioneering the development of digitized solutions for advanced therapies manufacturing. The platform offers customized workflow solutions to address challenges in the manufacturing process that were traditionally difficult to manage. The company’s commitment to quality and security is evident through their ISO certifications and dedication to regulatory compliance. If you’re a biotech or pharma company looking to streamline your manufacturing process, Autolomous Industries and autoloMATE® are the solutions you need.
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