One of the major issues at that time was that the software vendors hadn't planned for the ruling either, and although basic security features were built into many software packages, audit trails
were not, or if they were, they were not fully compliant with the requirements.
Data integrity is a current hot topic with regulatory agencies, as seen with recent publications in this magazine, (1,2) and audit trails
are an important aspect of ensuring this in computerized systems.
com)-- To-Increase, a provider of Microsoft Dynamics solutions for Industrial Equipment Manufacturers (IEM), details the benefits of Microsoft Dynamics audit trails
in a new blog post.
Yet, many companies still attempt to implement Part 11 audit trails
using plug in database tools that aggregate ALL database changes into large, unstructured data files.
Meeting stringent regulatory standards, tracking documents through their lifecycles, and creating audit trails
is becoming an increasingly complex activity that requires the integration of workflow, e-mail, documents, and images into a records management strategy.
are records of user activities within educational technology environments (ETEs).
Digital certificates also offer the security of audit trails
Change-detection techniques include audit trails
-- such as byte count, hash-control totals and formula-difference locators, all of which are explained later.
The Agency intends to exercise enforcement discretion regarding specific Part 11 requirements related to computer-generated, time-stamped audit trails
Also, since they generally lack the inherent controls and audit trails
typically found in commercial information systems, there is no way to ensure the integrity, of their data.