Audit trails

Take the example of two eye injuries that were entered on one company s OSHA 200. The first step could be pulling the 101s or First Reports of Accidents or Illness for the two eye injuries. Full evaluation of the reported information includes first checking on proper recording, and then evaluating background information as to why the eye injury occurred. The company had listed the cause of the injury as employee failure to wear eye protection. 

---

Workload status and the justification of equipment Regulatory agency compliance Audit trail for all database transactions Security class or hierarchy... 

These records provide audit trails to assure management s safety compliance and to aid it lent investigations. 

RISKMAN includes extensive error checking and configuration management fin c uality eontn 1. Key module elements and intermediate results are time and date stamped keystrokev of modifications leave an audit trail. 

Create checklists for assisting in following an audit trail through a department or process. 

Do follow audit trails to discover facts and don t break the trail until you have... 

The focus of MANAGER is somewhat different, in that it was primarily developed to provide a numerical output for use in risk assessment. Nevertheless, the qualitative dimensions included in the audit trail will undoubtedly provide information which can be used as part of an error prevention program. 

Computer systems must provide time-stamped audit trails to record actions that create, modify, or delete electronic records. 

Audit trail Does it support a full audit trail system ... 

Demonstrate that administrative changes to users and privileges are subject to audit trail. Demonstrate that the logged-in user ID is displayed on all screens. 

Record changes shall not obscure previously recorded information. Such audit trail information 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. 

Demonstrate that audit trails are created and maintained for Date and time of operator entries and actions that create, modify, or delete electronic records (methods, sequences, raw data, results, reports, calibrations, standards, event logs)... 

Admin changes to passwords Demonstrate that audit trail is... 

Demonstrate (refer to earlier demo) that user IDs are unique (cannot be deleted or redundant). If a user ID has been inactivated, can it be reactivated Would these actions be audit trailed If reactivation is not possible, how would a new user ID for a returning employee be linked to the past ID so all records created or signed by an individual could be queried (Does the system provide a technical solution, or would this be handled by a procedure ) Demonstrate controls include such configurable parameters as ... 

The software life cycle activities extend until retirement of the software. However, in a manner of speaking, life cycle activities extend even beyond retirement since the data must be able to be reconstructed at any time during the life of the product, i.e., the archived record must always be accessible and readable even if the software is no longer commercially available or typically employed in the laboratory. Additional software validation includes implementation of the code and integration and performance testing. There also must be system security, change control procedures, audit trails, calibration, preventative maintenance, and quality assurance. 

Automated electronic data capture systems have become increasingly important in the laboratory. They have improved the ease of manipulation and reporting of chromatography data. A regulatory requirement is that these systems must generate a permanent audit trail of the parameters employed in the collection and analysis of those data. 

The electronic data capture systems that have become commonplace in the research and analytical laboratory allow rapid and efficient acquisition, manipulation, and reporting of vast amounts of scientific data. In addition, they have provided a means to generate a permanent audit trail which describes the conditions under which a... 

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. 

Impact to network (does it run on LAN or WAN ) p. The security aspects of the system/ apphcation q. The audit trail function in the application ... 

QA should ensure that notes and various descriptions (e.g., sampling method, test system observations, etc.) are clear and thorough during the raw data audit. In addition, all audit trails should be checked for clarity and to ensure that each... 

When you start working across the Internet, the chromatography data system becomes an open system and the FDA rule requires controls. Using FDA s definition of electronic records, the laboratory chromatography data system generates electronic records. Based upon the definition, laboratories will need to consider more than just the raw data tiles. One must also include the method tiles, mn sequence tiles, and the integration parameters used for the data analysis. The need for a comprehensive audit trail is a critical component of the FDA regulations. The audit trail is an electronic record and is subject to the same controls. 

The audit trail must be retained with, and as long as, the original electronic records. In addition, the audit trail must be in an appropriate form for review or copying by federal investigators. 

No audit trail for changes to data or audit trail established, i.e.,... 

Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation. ... 

---