We’re excited to announce that CherryCircle Software complies with 21 CFR Part 11 and ISO/IEC 27001!
Over the past few months, we underwent an in-depth assessment by a third-party auditor to independently validate compliance of our company and our development practices with these industry expectations.
This extensive review covered three areas:
- ISO 27001: The ISO 27000 family of standards helps organizations keep information assets secure. ISO 27001 is the best-known standard in the family for organizations that provide Software-as-a-Service (SaaS) and are deeply committed to securing their client’s data.
- 21 CFR Part 11: Part 11 of Title 21 of the Code of Federal Regulations establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). The intent is to ensure that organizations implement and maintain controls over ERES in scope of the regulation.
- SaaS Assessment: A supplemental assessment of our technical solutions supporting: security, availability, processing integrity, confidentiality, and privacy; and organizational policies and processes regarding quality, governance, transparency, and communication. While there is no internationally recognized certification for completing this assessment, we felt it important to go above and beyond in our efforts.
Demonstrating compliance with these industry standards and regulations validates that the QbDVision team has implemented comprehensive practices that protect our users, their data, and their manufacturing information.
Security and Quality at Our Core
Since founding, security, quality, and fantastic customer support have been a core commitment of our organization. Often customers are surprised to learn how thorough we’ve been in building not only our products, but our company from a security and quality perspective.
We uphold ourselves to the same meticulous standards that our customers need to adhere to for their drug or biologic development and manufacturing. When given the choice, we often choose the more rigorous standards. For example, the basis of our quality system is ISO 13485. While we do not manufacture medical devices or software for medical devices, we voluntarily conform to this robust quality standard because it advances our corporate and product quality objectives.
Our comprehensive suite of governing policies and procedures ensure that our quality, security, and customer satisfaction goals are consistently met.
Our commitment to quality and security means we ship pharma-ready software. The QbDVision team has deep experience in the pharma industry. We know what it takes to bring our software into a GxP environment, and it’s important to us that our customer experience – from purchase decision, to onboarding, to drug or biologic delivery – be as seamless and successful as possible. Proactively pursuing and achieving demonstrated compliance with these rigorous industry standards and regulations are just one of many things we do to make that happen