Computer System Validation (CSV)
Sebald Consulting Works With Your Team to Accomplish Your Goals.
We can help you validate software and computer systems to meet FDA and EMEA compliance requirements, putting our decades of experience to work for you.
Software and Computer Systems
- Calibration and Maintenance Management (CMMS) Systems
- Document Management Systems
- Process Controls
- Supervisory Control and Data Acquisition (SCADA) Systems
- Analytical Systems
- Medical Device Software
- Database Systems
- Inventory Tracking Software
- Asset Management Software
- HVAC Controllers
- Alarm Systems
- Remote Notification Systems
- Electronic Records
- Electronic Signatures
- Medical Devices
We have experience with systems that are stand-alone, networked, SaaS-based, and other deployment formats.
If you need compliance with 21CFR11 and Annex 11 we can help!