Data recorders meet demanding FDA requirements
An
Eurotherm product story
Edited by the Engineeringtalk editorial team
Jun 14, 2001
Eurotherm's new data recorders have been specifically designed to meet the demanding requirements of the FDA (and other authorising bodies) for digital data storage and electronic signatures
Eurotherm has launched a new phase of its well-established 5000 Series data acquisition recorders.
The new instruments have been specifically designed to meet the demanding requirements of the FDA (and other authorising bodies) in relation to digital data storage and electronic signatures.
They can be delivered complete with all necessary documentation to validate to GAMP3 and CFR21 Part 11 requirements.
The latest Series 5000 instruments intrinsically comply with the requirements of GAMP3, and this is supported by a new documentation / validation service from Eurotherm.
When required by a customer Quality Assurance department, a functional specification is created along with a test specification for the Installation Qualification.
The recorder will then be supplied configured and tested to the standards required by the guidelines.
For most applications, acceptance to GAMP Category 2 is most applicable.
This is because the product has been designed to have its operating parameters documented only, not configured.
Should the application be more complex (where the data is being manipulated in some way, for example) validation to Category 4 may be needed.
This can also be provided, by creating a project plan for the application and specific documentation.
As required by the FDA's CFR21 Part 11 (concerning data traceability), the new 5000 Series has full security access, controlled by unique operator logins.
Additionally, digital signatures with password checks are required before annotating onto archive files.
A Batch Control option includes features such as clearing of data fields and electronic signatures.
All information is time-stamped and embedded alongside the process data.
Archive files are binary encoded with checksums that prevent unauthorized tampering.
When used within an Ethernet communications environment, the files are automatically transferred to a secure server to ensure no loss of data.
The MAC address of the recorder is included within archive files so that there is no doubt where the data has come from.
Eurotherm say that samples of instrument validation documentation are available to prospective customers prior to purchase, thus allowing Quality Managers to demonstrate that their specific validation requirements will be met.
By e-mailing an enquiry to Eurotherm at 5000GAMP3@eurotherm.co.uk, providing a return contact name and email address, sample validation documentation for the new instruments will be sent back by return.
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