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FDA 21 CFR Part 11 Compliance

FDA 21 CFR Part 11 Compliance
Finding materials testing software that adheres to FDA 21 CFR Part 11 has long been an issue in the medical industry where data integrity is key to the safe, traceable materials testing of pharmaceuticals and medical devices.

While many materials testing machine suppliers claim that their software or machine solutions adhere to FDA 21 CFR Part 11, often they do not, and the common misunderstanding that a software alone is enough to adhere seems to continue to flow in the industry. 

Read the full article about FDA 21 CFR Part 11 compliance before you purchase your materials testing solution for the pharma or medical device industry.

How Can We Help?
Key to compliance are procedures and controls that ensure the authenticity, integrity, and confidentiality of electronic records from the point of creation to the point of receipt. For companies starting this process, Lloyd Instruments provides a complete software and testing machines solution.

The pharmaceutical and medical device industries have trusted NexygenPlus for decades, and the software has long proved its reliability, accuracy, and ease of use. Now, with the new NexygenPlus 4.1 software, audit trail data is stored in a secure SQL database where Admin users can find extensive logs containing information including:

- Timestamps
- User IDs
- Computer name
- Changes to machine setup
- Machine error events
- Changes including old and new values
- Printing of reports
- User authentication

A superviser can set the level of access for users and prevent unauthorized access. An optional IQ/OQ package is available that includes test result calculation verification. A certificate is provided upon completion.

Get an introduction to the NexygenPlus 4.1 data analysis and materials testing software. In this video you will get a thorough walk through of the key features that are crucial for pharmaceutical and medical device manufacturers that need to adhere to FDA 21 CFR Part 11.

Request more information to see how we can help you with a medical device testing solution that suits your needs.