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FDA 21 CFR 11
FDA 21 CFR 11 -
FDA compliant measurement data acquisition with Message systems
Background to FDA 21 CFR Part 11
The American Food & Drug Agency (FDA) is responsible for regulating public health in the US. The 21 CFR Part 11 regulation sets out requirements whereby electronic and paper recording are deemed equal. These requirements are binding on the US market as well as for all companies which supply this market. Because of this, many German companies have carried out validation procedures for their production and research plants. This enables them to offer their products and research results to the US market.
There now also exists a European guide on "Good Manufacturing Practices" (GMP). Part 11 of the EU-GMP sets the requirements for computer supported systems in GMP areas.
Realization using Message devices
The FDA requires uninterrupted and tamper-proof data acquisition. These requirements are met by Message devices. They are equipped with an internal data logger providing an autonomous measurement data acquisition capability. A further FDA requirement is a traceability function. It must be documented that a particular piece of equipment actually produces its expected outcome. Message devices are calibrated and justified. Measured data is therefore always traceable. The FDA also demand that measurement data is protected from any unauthorized access. Message devices are equipped with an integrated user-management system. Message software includes an audit trail feature which records all process relevant user actions. Every action is recorded with the date, time, user name and action.
Important FDA related functions within Message devices and MHouse software:
- Hardware and software protection via user management
- user set up and management
- allocation of user rights for different functions
- compulsory password changes at fixed time intervals
- audit trail function can be switched off - Audit trail stored as encrypted and tamper-proof
- Redundant audit trail acquisition in different files
- Plausibility and manipulation checks on audit trail
Message devices equipped for validation
Message devices are equipped to achieve validation for an entire plant. The necessary documentation - Installation Qualification (IQ) and Operational Qualification (OQ) - can also be provided by Delphin. The IQ is the documented proof that the system has been supplied and installed according to requirements and statutory regulations. The OQ documents the requirements for the entire operational spectrum.
Delphin's measurement data acquisition systems have been validated many times by renowned companies in the chemical and pharmaceutical industries.
We will be pleased to advise you on your system selection and provide support through to system launch and validation.
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