SmartAuditTrail? - a software solution to implement Audit Trail, manipulation prevention and access control for Windows? based systems
Anton Neuber
Connect People, define a target, GO for it! #QA/QC #Data Integrity #Compliance #EBR #Pharmacovigilance tools for worldwide Pharma&Process Industry
Does the software used in your organization meet the requirements of Good Manufacturing Practice (GMP)and Good Laboratory Practice (GLP)?
GMP and GLP define the requirements to comply to during production and research related to pharmaceutical products, essences, cosmetics, food and wellness related products. Documentation requirements increase as result of legal obligations dramatically.
This includes the information technology being used to control and run the production and analytical processes in lab environments:
· Computer systems are required to file relevant activities in an Audit Trail.
· Raw Data: Generated results are to be protected against manipulation and deletion.
· Access Control: Access to electronic records need to be limited to qualified and authorized employees.
· Archival: Systems need to support archiving and access after request in case of an audit.
Especially legacy systems are not able to serve these requirements. The software solution SmartAuditTrail? provides a wide range of opportunities to implement the required security and data integrity features on Windows? based systems and can be customized to the specific requirements.
Beside the tracking of user activities in the audit trail, SmartAuditTrail? is able to track file access and manipulation in local and network folders.
SmartAuditTrail? does not touch or manipulate any data during this process.
To prevent users from performing unauthorized activities, controls or dialogs can be locked to not allow any entry by users. ?Event on Demand“ functionality allows SmartAuditTrail? to copy data immediately after being generated to a secure location to prevent any manipulation. (It is also possible to be initiated together with a mouse click on a control in a software dialog of the application used in the GXP environment.)
Some examples of locked functionality:
- Controls and dialogs of an application can be locked to prevent unauthorized access or usage.
- Execution of software on a computer can be limited to approved applications.
- Access to USB storage devices as well as drives can be locked.
https://www.smartaudittrail.com
SmartAuditTrail? supports all Microsoft Windows based applications following the Microsoft recommended best programming guidelines, Citrix Terminal Server based applications, Minitab, Microsoft Excel Dokuments on cell level, ... ... ... . Please feel free to request an evaluation appointment!
Our team is very happy to provide additional information or to do a demonstration of the opportunities offered by SmartAuditTrail?!
Greetings from Vienna/Austria,
Anton Neuber