Aparito manages compliance with quality and regulatory requirements through the Aparito Management Platform (AMP™).
AMP™ combines quality and management and integrates risk management and data integrity in every component of the platform.
AMP™ enables you to:
- Keep CSV/CSA of products streamlined and effective.
- Support informed decisions, allowing decision-makers to formulate strategies and plans based on data which contributes to strengthening your reputation as a responsive organisation.
- Swiftly identify and correct potential non-conformities following deviations and complaints diagnosed and recorded in AMP™.
- Implement and track action plans for changes and CAPAs necessary for improving processes and reducing risk.
- Efficiently manage the complexity of data and processes with features and tools to track changes such as protocol amendments, ensure data traceability through a digital audit trail, and facilitate the detection of potential errors or inconsistencies in information.
- Keep your team audit ready.
Our Credentials
21 CFR Part 11 compliant
Cyber Essentials Plus
ISO 13485
ISO 27001
- 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 eCOA 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)