Data integrity assurance

Laboratory Data Integrity Assurance Division, Office of Compliance Monitoring, U.S. Environmental Protection Agency, Washington,... 

Instance of time expectation and feedback message Instance of connection authentication of lEC 61784-3. Instance of data integrity assurance of lEC 61784-3. 

Documentation of procedures assuring that data are accurately recorded to preserve data integrity should include audit trail reports indicating all data entered, chauiged, or deleted. These reports should be reviewed thoroughly by the appropriate personnel. 

Laboratories utilizing automated data collection systems must provide such control of those systems that current and future system performance can be assured and that data integrity can be maintained. Consistent, accurate, and reliable system performance depends on the control of laboratory facilities and equipment requirements, as well as software requirements. Functional testing, a requirement for both equipment and software, and source code review of software are also required to provide control of system performance. 

In addition to the retention of operating data in electronic format, the following list shows the supporting documentation that should be archived along with the data. The integrity of archived data is assured when the systems on which the data was produced have been validated, and the documentation relating to these systems has been assembled, as part of the validation file. 

Security protection is provided to assure data integrity. Database access is controlled to prevent unauthorized user access (for example, to sensitive areas) and to prevent unauthorized operations (for example, delete a record). 

Failure to establish and implement computer security to assure data integrity in that during this inspection it was observed that an employee was found to have utilized... 

Failure to establish and implement adequate computer security to assure data integrity in that during this inspection it was observed that an employee was found to have utilized another person s computer access to enter data into the XXXX computerized record system. [21 CFR 211.68(b)] Review 21 CFR Part 11 for regulations pertaiiung to the... 

Due to the critical nature of the data stored in the LIMS database, data integrity must be assured. Current technology allows for disk mirroring to ensure that any database additions and changes (and therefore changes to electronic records) are copied to additional, and possibly remote, locations. The function and use of each mirror for backup, for disaster recovery, and for system startup after shutdown must be understood. Each of these scenarios must be tested as part of the validation. 

Such a situation offers both benefits and challenges. Parallel testing, i.e., the running of two systems in parallel and comparing the outputs, offers the opportunity of increasing the level of confidence that the system meets all expectations and user requirements. However, at some point, cut-over to sole operation of the new or modified database will have to be achieved. A crucial consideration here is the assurance that all records from the previous system (be they manual, from a different database, or from a smaller version of the new database) are available for further processing, inspection, and manipulation, and most importantly, have had their data integrity preserved. This is usually achieved by validation of the process used to transfer the data into the new system. 

Assurance of data integrity by keeping the reference data current, cleansed, and filtered... 

At the other end of the spectrum, are standards which address the processes of development and manufacture - non-safety examples range from the very broadly based ISO 9000 series to the more specific ED-78A (Guidelines for the Approval of the Provision and Use of ATS Supported by Data Communications) and ED-109 ( Guidelines for CNS/ATM System Software Integrity Assurance). In none of these cases would it be appropriate to certify a product against them, from a safety viewpoint however, compliance with such standards, especially the more specific ones, could provide excellent Backing Evidence for safety requirements... 

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