We are committed to delivering healthcare solutions that meet the highest standards of quality, safety, and regulatory compliance.
This policy fulfills the requirements of ISO 13485:2016 (Medical Devices), ICH- GCP (Clinical Trials), and FDA 21 CFR Part 11 (Electronic Records).
We ensure that all clinical trial analysis and CRO activities adhere to the highest standards of ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, and Traceable). We utilize Explainable AI (XAI) to provide transparent, audit-ready insights for our pharmaceutical partners.
Valphoray cannot just "use" an AI. Valphoray must have a Computer System Validation (CSV)package that proves the model is "Fit for Purpose."
We provide medical equipment, implants, and blood bank technologies that meet or exceed international safety standards. We guarantee 100% traceability through Unique Device Identification (UDI) and rigorous "Cold Chain" management for sensitive disposables.
For your medical disposables and blood bank equipment, "Good Distribution Practice"(GDP) starts with your suppliers. Use this checklist to qualify new partners.
Does the supplier hold a valid ISO 13485 (Medical Devices) or ISO 9001 (General Quality) certificate?
Is the manufacturer registered with the relevant authority (e.g., FDA Establishment Registration or CDSCO MD-form)?
Can the supplier provide barcodes/labels that comply with Global Unique Device Identification standards?
Does the supplier hold a valid ISO 13485 (Medical Devices) or ISO 9001 (General Quality) certificate?
Is the manufacturer registered with the relevant authority (e.g., FDA Establishment Registration or CDSCO MD-form)?
Can the supplier provide barcodes/labels that comply with Global Unique Device Identification standards?
Can they provide ISO 10993 reports for any blood-contacting disposables?
Does the supplier provide a Certificate of Analysis (CoA) and a Certificate of Sterility for every batch?
Has the supplier provided "Accelerated Aging" data to justify the shelf-life of the disposables?
Can they provide ISO 10993 reports for any blood-contacting disposables?
Does the supplier provide a Certificate of Analysis (CoA) and a Certificate of Sterility for every batch?
Has the supplier provided "Accelerated Aging" data to justify the shelf-life of the disposables?
Since you are using AI, your QMS should be proactive. I recommend tracking these 3 Key Performance Indicators (KPIs):
| Metric | Target | Purpose |
|---|---|---|
| Model Drift Score | < 2% | Ensures AI clinical analysis remains accurate over time. |
| Recall Readiness | < 2 Hours | Time taken to identify the location of all units in a specific batch (UDI Trace). |
| First-Pass Acceptance | > 98% | Percentage of clinical data sets accepted by pharma clients without |
