AssurX is the most flexible and intuitive solution on the market. It is also the most user-friendly from both the end user and administrative perspective. AssurX is 5–10 years ahead of their competitors.
Quality Management + Compliance for Medical Device Manufacturing
Maintaining the highest quality levels, and a strict state of control and regulatory compliance not only affects the bottom line, it can literally be matters of life and death for medical device manufacturers. In addition to the FDA s stringent device regulation requirements, medical device manufacturing companies also face serious regulatory scrutiny from the Department of HHS and its HIPAA patient privacy regulations. It is incumbent upon medical device manufacturers to use software, hardware, and system processes that ensure only those personnel required to see a given piece of data are in fact allowed to access it. AssurX software is designed with global quality management and medical device regulatory requirements in mind. Successful companies use AssurX s, seamlessly integrated software to centrally monitor, manage and improve their quality and regulatory compliance related processes across all operations.
The AssurX Platform provides an end-to-end, flexible system for managing quality and regulatory compliance including FDA requirements for:
- Establishment registration 21 CFR Part 807
- Medical device listing 21 CFR Part 807
- Premarket Notification 510(k) 21 CFR Part 807 Subpart E
- Premarket Approval (PMA) 21 CFR Part 814
- Investigational Device Exemption (IDE) 21 CFR Part 812
- Quality System (QS) Regulation/Good Manufacturing Practices (GMP) 21 CFR Part 820
- Labeling requirements 21 CFR Part 801
- Medical Device Reporting (MDR) 21 CFR Part 803
In addition, Assurx software provides pre-configured solutions that create closed-loop solutions deliver fully FDA-compliant processes to manage complaints. supplier quality. document control. CAPA. change. audits. and and training. A state of control and proof of compliance is maintained continuously in one central, securely accessible system. The AssurX software is validated and comes with IQ/OQ validation templates. Each pre-configured solution comes with a PQ based on industry best practices and the latest regulatory guidelines.
For us the benefit of using AssurX is the audit trails, electronic signatures and workflow control. Before AssurX our processes didn’t move. AssurX enables us to know who is doing what, and when they need to have it done.
– LiseAnn Bailey, Global Cardiac
Assist Device Manufacturer
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Compliant Audit Trail, Electronic Signatures
Built to ensure FDA compliance, the software incorporates audit trails and electronic signatures compliant to 21 CFR Part 11 and maintains an easy to access, secure time-stamped archive.
• Audit trail of all MedWatch 3500 as submitted, as well as all follow-ups, modifications, and attachments
• Query on all audit trails
• View edits/changes in any form in the audit trail showing the before/after field values
• View changes on entire record at once, not just individual fields
• Electronic signatures cannot be modified, copied, transferred or deleted
• Accommodates signature comments