Regulatory Compliance

Adhering to key regulatory and compliance requirements is integral to the Atom5™ platform and it operates under ISO143485 QMS and ISO/IEC 27001 ISMS accreditations and is FDA 21 CFR Part 11 and GDPR compliant.

Aparito partners with DocuSign to deliver a secure eConsent solution to ensure that ongoing consent is maintained throughout the course of a clinical trial.

Our Credentials

21 CFR Part 11 compliant

Cyber Essentials Plus

ISO 13485

ISO 27001

ePrivacy App

Crest

• We are 21 CFR Part 11 Compliant, which means we meet the FDA’s regulations for electronic documentation and electronic signatures for a medical device company’s quality management system
• We are Cyber Essentials certified, a UK government program for information assurance and is the minimum certification that is required for a government supplier responsible for handling personal information in the UK. Cyber Essentials Plus has the Cyber Essentials trademark simplicity of approach but includes a hands-on technical verification
• We achieved ISO13485:2016 accreditation for our Quality Management System (QMS) for the design, development, manufacture and installation of our patient management software platform Atom5™
• We are audited to ISO27001 which is the only auditable international standard that defines the requirements of an information security management system (ISMS)
• We have the ePrivacyApp certification awarded by ePrivacyseal GmbH, which involves extensive testing and certification of the app in question with a view to ensuring the protection and security of the data concerned within the app
• We have all our web and application-based solutions penetration tested annually by CREST-certified testers

As a platform developed with compliance and regulatory requirements at its core, Atom5^TM surpasses the compliance criteria required to provide a global clinical trial platform so you can be assured that by working with Aparito, regulators’ needs are met.