NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

AUTOLOMOUS LTD are a relatively new Private Limited Company . They have been trading for 2 years. (AUTOLOMOUS LTD was incorporated on 6 February 2019 as a Private Limited Company in UK). They operate in the Business and domestic software development sector. Autolomous' approach focuses on collaboration and adding value to all manufacturing efforts within advanced therapies.(Mark Lowdell is one of co-founders)

Autolomous provides manufacturers with ways to scale their operations, by deploying a fully integrated and digitised supply chain ecosystem.
They streamline the management of manufacturing data, by integrating siloed information into one digital platform: AutoloMATE®.

Advent Bioservices is one of their industry partners.

On October 7, Autolomous announced the achievement of ISO 9001:2015 and ISO 27001:2013 certification, an important milestone for the company.

I believe that achieving ISO 9001:2015 and ISO 27001:2013 certification is important for the assessment of the GMP application for the Sawston facility. (and one of the reasons for the delay)

Autolomous: ISO 9001:2015 & ISO 27001:2013 certified

October 7, 2021

Autolomous achieves ISO 9001:2015 and ISO 27001:2013 integrated certification, further demonstrating the company’s commitment to the highest level of conformance with quality management and security standards.

London, UK, October 8, 2021 – Autolomous LTD, the market-leading developer of critical manufacturing management systems for cell and gene therapies, today announces it has achieved ISO 9001:2015 and ISO 27001:2013 certification from QMS International.

A central part of Autolomous’ client engagement strategy is to surpass the current quality and security requirements expected of critical suppliers to the sector. Autolomous will join a select group of cell and gene therapy suppliers with ISO certification. This will provide an additional incentive to companies across the cell and gene therapy supply chain to partner with Autolomous to strengthen existing cell and gene therapy collaborations. It will also help to accelerate the growth of Autolomous’ early adopter client base with Autolomous’ business-critical digital platform, AutoloMATE®.

The integrated ISO certification demonstrates that Autolomous’ management systems, covering in scope provision of AutoloMATE® and its IT services, conform and operate to internationally agreed standards. This includes both Quality Management Systems (ISO 9001) and Information Technology Security Techniques and Information Security Management Systems Requirements (ISO 27001).

Obtaining certification for ISO 27001:2013 involves implementing 114 specific security measures, organised into 14 sections, followed by an ongoing 3-stage audit process. The ISO 9001:2015 standard complements the above, requiring seven key areas to be addressed to achieve continual improvement: Context of the Organisation, Leadership, Planning, Support, Operation Performance Evaluation and Improvement.
Autolomous operates in a highly regulated environment. The AutoloMATE® platform has been designed to be compliant with U.S. and EU regulations for electronic systems including (FDA 21 CFR Part 11 and EU GMP Annex 11). Autolomous’ integrated certification is the latest successful achievement in its commitment to maintaining the security of sensitive data. As Autolomous is deploying leading-edge technologies, ISO accreditations will provide reassurance for customers and patients that its services are implemented to the highest quality and digital security standards.

“Autolomous achieving its new ISO certification will provide all clients and prospective clients with the assurance that Autolomous and its services are in conformance with current and future international standards. This certification is essential for organizations throughout the cell and gene therapy sector to demonstrate the highest possible standards and conformance for this clinically advanced sector,” said Alexander Seyf, CEO, Autolomous. “The two ISO certifications are a continuation of the rapid progress Autolomous has been making over the past two and a half years. This will enable us to quickly build on the eight platform deployments, two UK government-supported projects, eight integrations with CGT eco-system suppliers and a completed investment round we have achieved within this short time frame.”

https://autolomous.com/autolomous-achieves-iso-90012015-iso-270012013-integrated-certification/