|
 |
Tech Support
FermWorks Tech Support
|
|
| |
FermWorks 21 CFR Part 11 Compliance
|
Companies with products and processes in the medical industry must confront the same time-to-market, cost control, and quality assurance challenges as our electronics industry customers. The medical industry faces a far more complex product design and manufacturing process because of the unique requirements for compliance with FDA regulations regarding the record management process.
Jova Solutions supplies automation products and services for the medical device, pharmaceutical and biotechnology industries, we work with our customers to design and implement features so they may use our software products in an FDA compliant manner.
We provide all of the required software functionality for Part 11 compliance. Our software systems integrate the processes for creating, modifying, maintaining, archiving, retrieving, transmitting and maintaining the integrity and security of electronic records and electronic signatures and enable companies to avoid manufacturing delays, regulatory fines and missed revenue opportunities while complying with complex regulatory requirements. Jova Solutions is committed to providing software solutions that provide the trace ability the medical industry must have in their development environment.
| |
|
|
- Seamless integration with hardware
- Client/Server-based data management system
- Complete audit trails
- Validated time stamps
- Version control of all files
- User access management
- Data archiving
- Document life cycle management
- Electronic signatures
- Standard Operating Procedure (SOP) checking.
|
 |
U.S. Food & Drug Administration |
|
|
|
|
