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2100 Bioanalyzer - Compliance
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- 21 CFR Part 11 compliance – All requirements regarding electronic records and electronic signature are addressed, including data security, integrity and traceability.
- Secured environment – Nobody can acquire or access data without dedicated user account and identification. All actions are tracked and documented with a clear, traceable audit trail and electronic signature.
- User identification and roles – Only users with valid user ID and password can log on, access and modify electronic records. Software limits the user functionality, as defined by his role
- Workflow management – The executable methods can include a predefined workflow, which defines who will be allowed to execute methods, perform peer reviews, and provide final approval.
- Compliance services – Software and hardware IQ and OQ can be purchased at any time. A certified customer engineer will test and verify the functionality of the hardware and software, thereby qualifying the system.
- Design Qualification (DQ) - defines the functional and operational specifications of the 2100 bioanalyzer and ensures it has all necessary functions and performance criteria.
- Installation Qualification (IQ) - ensures that the 2100 bioanalyzer is installed correctly, documenting the completeness of shipping, the operational environment, and the components of the system
- Operational Qualification (OQ) - demonstrates that the 2100 bioanalyzer will function according to its operational specifications.
- Performance Qualification (PQ) - Standard Operating Procedures (SOPs) are developed by the customer for PQ.
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