WinWedge helps you meet FDA 21 CFR Part 11 requirements by ensuring your instrument data gets properly tracked and transmitted to your compliant systems.
What Does 21 CFR 11 actually require?
When you’re working in FDA-regulated industries, all electronic data needs to be tracked with information like who collected it, when, and from which instrument. This data trail has to stay with your measurements and be stored in a way that meets regulatory standards.
How WinWedge fits into your compliance setup
Key thing to understand: WinWedge isn’t data storage software – it’s the bridge that gets your instrument data safely to your compliant database or LIMS.
What WinWedge does for compliance
- Data integrity: Captures data directly from your instruments (no manual typing = no transcription errors)
- User attribution: Adds user identification, timestamps, and instrument details to your data
- System integration: Transmits everything together to your 21 CFR 11-compliant LIMS, databases, or quality management systems.
Making older instruments compliant
Many newer instruments can send user and timestamp information automatically. But if you have older equipment, WinWedge can add the required identifiers to make your data compliant with metadata like:
- Operator names or ID numbers
- Date and time stamps
- Instrument identification
- Any other tracking information your process requires
Why choose WinWedge for compliance?
- Cost-effectiveness: WinWedge works with whatever compliant database or LIMS you already have—typically at a fraction of the cost of expensive, all-in-one solutions.
- Flexibility: Whether you’re using Excel with proper controls, a full LIMS system, or a custom database, WinWedge can feed data to it.
- Security: Everything runs locally on your systems, with no cloud dependencies or external data transmission. Learn more here.
Industries using WinWedge for 21 CFR 11
- Pharmaceuticals: QC testing data from analytical balances and dissolution testers
- Medical device manufacturing: Production scales, test equipment measurements
- Clinical labs: Patient testing data from analytical instruments
Getting started
The best way to see if this works for your setup is to try it. Download the free trial and test it with your specific instruments and database setup.
If you have questions about configuring WinWedge for your 21 CFR 11 requirements, give us a call – it’s often easier to explain the specifics over the phone once we understand your particular setup.
Here are a couple of resources that might be helpful in learning how to use WinWedge:
- Quick Start Guide: This walkthrough uses an example of a Sartorius scale sending weight to Excel, but demonstrates how WinWedge can be configured to send any serial instrument data to any application that receives text, including any additional metadata needed for compliance.
- Video Walkthrough: Covers similar setup steps