Managing Data Integrity
The data integrity generated by your medical device or laboratory services is a critical factor in measuring your credibility.
Regulators, acquirers, clients and partners cannot examine all your data. In lieu of an exhaustive examination, samples are assessed within the context of your data management policies and procedures. One known instance of compromised data – or even a poorly designed data management system – will call into question all your data generating activities.
What is impacted by the quality of your data? Everything if your…
- Medical device produces data for the patient or a clinician
- Laboratory supports the clinical information needs of a client
What happens if your data is compromised?
- Your reputation can suffer which can erode profitability
- Regulators can force the cessation of sales and a product recall
- Overhead and opportunity loss increases due to the diversion of resources needed to address the problem
This isn’t just about compliance. This is about the quality of your output… your reputation… the sustainability of your business.
Proactively addressing the integrity of your data is a sound business decision. MethodSense understands the FDA criteria for data integrity. From 21 CFR Part 11 to AlCOA, MethodSense can help you practically implement the processes and plans designed to both achieve compliance and support data integrity. Some of our data integrity solutions include:
- Software validation
- Instrument validation
- Software development lifecycle processes
- Vendor management
- Equipment qualification
- Software risk assessments