Improves information security and compliance: Accessing and processing sensitive data without human involvement reduces the risk of exposure and enables defensible audit trails and chain of custody.
For laboratories working under the FDA's 21 CFR Part 11 regulations, xPONENT offers multilevel user management, full audit trail, electronic records, and electronic signatures.
This includes hardened systems, data encryption, advanced authentication controls, integration with existing security infrastructures and tamper-evident audit trails.
In its analysis, Iitri did not find adequate provisions--[for example], audit trails-- for establishing individual accountability for actions taken during the use of Carnivore," stated the report.
The entire design process, from concept to the time the design was approved, was managed on the CDE with audit trails and an issue resolution process in place.
Readily available software packages such as METTLER TOLEDO's LabX or STARe need only be validated once, and every new analytical instrument attached will simply require an amendment via change control as the software, data management, audit trail, user management, result flow, etc. already are validated.
Astea Alliance also helps in addressing Title 21 CFR Part 11, by providing the ability for generating electronic records and signatures, controlling the use of computer systems, lot and serial number traceability, audit trails, archiving, and security.
For example, there are requirements for maintaining the durability of the data(§ 7.1), backups(§ 7.2), the audit trail(§ 9), or the justified modification of the data(§ 9 and 10).
We recommend that you base your decision on whether to apply audit trails, or other appropriate measures, on the need to comply with predicate rule requirements, a justified and documented risk assessment, and a determination of the potential effect on product quality and safety and record integrity.
Pharma-compliant software features like user management, comprehensive audit trail and electronic signature in combination with our Pharma Qualification Packages facilitate compliance and traceability, reducing the work required to integrate the new device into your system.
We recommend that you base your decision on whether to apply audit trails, or other appropriate measures, on the need to comply with predicate rule requirements, a justified and documented risk assessment, and a determination of the potential effect on product quality and safety and record integrity.
Data integrity options in STARe thermal analysis software- tailored to different needsSTARe software provides password access-control to the application, assigns user-rights for each user-level, ensures file integrity with electronic records stored in a secure database, and properly logs the audit trail and electronic signatures.
Project Management: Tracks every project from several different perspectives-complete project details, timelines, all project related files, audit trails of status/events, PO numbers, invoices, translation memory updates, and reports are all maintained in one place.
Getting a requisition approved used to take three weeks, sometimes longer. Now, we complete most requests in only three days. More importantly, MetroHealth is sure everyone followed the right procedures and can prove it with audit trails.".
Even if there are no predicate rule requirements to document, for example, date, time, or sequence of events in a particular instance, it may nonetheless be important to have audit trails or other physical, logical, or procedural security measures in place to ensure the trustworthiness and reliability of the records.
Data is the New Gold It's important to be sure that all the steps performed by your Digital Workers can be audited and explained along the way-especially because of regulatory requirements and compliance audits- but also because having a strong, built in audit trail and metrics from your processes and Digital Workers enables you to identify areas for greater cost saving and process efficiencies.
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