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6000 Series graphic recorder

6000 Series graphic recorder
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6000 Series graphic recorder and 21 CFR Part 11 Sub Part B – Electronic Records 11.10 Controls for closed systems (a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. Eurotherm® offer assistance in validating products to GAMP guidelines. Recorded files are in binary, compressed and check-summed format proprietary to Eurotherm. Details are not published. The viewing tool rejects invalid/altered (ie incorrectly check-summed) records. Extensive testing is carried out by Eurotherm Ltd, an ISO 9000 approved company. Validation (and maintenance of the validated state) is further supported by automatic incrementing of configuration/security version numbers each time a change is saved. These numbers are stored to the audit trail both on power up and on start of batch. They are also available as ‘maths’ functions to allow them to be trended if the customer requires this. (b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records. (c) Protection of records to enable their accurate and ready retrieval throughout the records retention period. Complete and accurate copies on screen or printed out are available through the use of the Review package. Complete and accurate electronic copies are available by copying the raw data files or by setting up a ‘pdf printer’ (requires adobe acrobat or similar) in order to export graphs in pdf format. The product also supports direct connection of an ASCII printer to which values, messages and reports can be logged. (6100A/6180A only) On the recorder, files are held internally in Flash then archived to Removable media and/or via a network to an FTP server. Data can also be periodically pulled from the product using Review. Once data has left the recorder, the media it is stored on and backup strategy is the responsibility of the user. (d) Limiting system access to authorised individuals. Record Manage Optimise Individual password protected user a

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Sub Part B – Electronic Records (continued) 11.10 Controls for closed systems (continued) (e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying. Secure (embedded in the binary history file), computer generated,...

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11.50 Signature Manifestations (b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout). Name (ID), timestamp and meaning are all embedded in the binary format history file. 11.70 Signature/Record Linking Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be...

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Sub Part C – Electronic Signatures (continued) 11.200 Electronic signature components and controls (3) Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals. Users can change their own passwords and no read access to passwords is provided. So, unless one user tells another their password, it is impossible to commit fraud without an audit trail of that fraud being left. It is further possible to force system administrator changes for user accounts to be...

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