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| Home > Products > Spectra > Prisym Device |
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| Your own devices |
PRISYM Device is a feature rich module that enables a safe, accurate and traceable labeling environment for the compliant distribution of medical devices.
PRISYM Device complies with the requirements of 21 CFR Part 11, GCP and GMP and can help in meeting; GLP, GCP and ISO requirements for medical device product labeling and record keeping. |
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| Deliverables |
- Medical device label printing and management
- Distributed labeling capability
- Automated multi-language capability
- Proven date and time stamping
- Password protected records
- Secure access, event and audit logging
- Customization of user-defined data variable
- Full product life cycle documentation
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| Options |
- 21 CFR Part 11 compliant
- GAMP 4 based product life cycle documentation
- Biometric user recognition
- Customized validation of installed system
- Custom software development and integration
- Custom database design and integration
- Customized maintenance and servicing
- Customized support and training
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| Applications |
- Medical device labeling
- Distributed materials/products storage and distribution
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