Audit trail report documents

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. 

In a GLP-compliant electronic record keeping system, original raw electronic data will not be altered, but these data can be presented and interpreted for reporting. Any changes to the raw data are documented and maintained as audit trails. The audit trail becomes a part of the raw data for the study and is archived as such. 

Although it is the most important single document, the final published report is only a portion of the overall record of the investigation. A full and complete set of documents should be maintained for future reference. This systematic documentation package is sometimes referred to as the audit trail. It provides subsequent reviewers and investigators with the opportunity to understand the team s decisions and analysis more completely. The document set should contain lists of relevant files. All documents associated with the investigation should be preserved according to the company records retention plan. 

The procedure should include review of all the collective information in the validation file to confirm the validated status of the system and ensure data records that are to be retained in support of released product are available. The requirements necessary to conduct and report the archiving of GMP records need to be defined, and should identify all life-cycle documents, electronic raw data, electronic records (including associated audit trail information), and system application/operating software that are to be archived. 

Reports may be considered to be reviews. For electronic documents that provide an interpretation of data drawn from electronic records that are already subject to control, there is no clear need to reimpose these controls until the document is used for some official purpose. In a case of submissions, once a submission has been assembled and approved ready for submission to a regulatory agency it would then become an electronic record subject to audit trails. 

The current good manufacturing practices (GMP) state that Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards [5]. This includes all electronic and hard copies of raw data, laboratory notebooks, and/or worksheets and reports. Additionally, the regulations require that records shall be readily available for authorized inspection [6]. Consequently, the organization must have a well-defined audit trail for the generation, storage, and retrieval of reports and raw data. It must also be shown that there is adequate document management and security of all raw data and reports in terms of both disaster recovery and prevention of falsification of results. 

Archive and Retrieval of Documents and Records User Results Input and Displays Analytical Report Generation Audit Trail Verification... 

Requirements for data presentation, records, and reporting Audit trail requirements and copying of records Communication with external devices Networking requirements Performance requirements Availability Security Maintenance Documentation... 

Protocols that accept electronic inputs such as the sample dilution factor or number of diluents present one additional complication knowing what the instrument actually did. Just as a manual dilution process requires documentation of the various parameters used in the dilution, so does an automated dilutor. This information may be captured in an audit trail, but it is generally necessary to store this information with the assay documentation where it can easily be cross-checked against the parameters in a LIMS. This creates a requirement for the automated dilutor to generate a report of sample IDs, actual dilutions performed, number of... 

Each and every operation dealing with a file, be it a manipulation or evaluation, will automatically be documented and added as audit trail to the file in terms of the data block wTWffl. You have access to this history report by right-clicking on this icon. 

Establish an effective safety management system/process. Nominate key roles/ responsibilities. Define approval signatories - especially for safety reports. Establish independent verification/audit to reduce chance of undetected error. Establish a workforce-wide commitment to product integrity. Learn from previous mistakes. Initiate a documentary audit trail (identify, log and track all hazards). Airworthiness and safety must be foremost in the minds of the entire organisation. Furthermore, as many legal cases turn on documentation, it is essential that risk assessment activities and choices are documented and that records are kept. ... 

Methods of sample handling are well documented and assure a good trail-of-evidence from time of sample receipt at the laboratory to time of the report audit. However, information received from the field for individual samples is often incomplete. 

The other piece of the closed loop is periodic review of the system safety process. This is the fine-tuning of the system safety program and review at the macroscopic level and should be conducted by an independent safety group to avoid conflict of interest. This is precisely why the system safety office should report directly to the corporate office. The purpose of the review and audit is to verify that the system safety program is in place, performs its intended function, and adequately protects employees, consumers, and the eompany against accidents and other losses. It also serves as a documentation trail for OSHA inspectors, showing that your organization takes safety seriously. 

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