Stable and secure

Stable Micro Systems is offering an enhanced security module for its Exponent software in accordance with 21 CFR Part 11 guidelines.

The module includes a number of features to improve security for customers as well as facilitating continuous monitoring and tracking of results and records. An encrypted log-on password of at least seven characters, combined with password protection for validation of calibration checks, are incorporated into the system. In addition, multiple hierarchical levels of user profiles are available and electronic signatures can be used for record certification.

Another important feature is the ability to copy and print out audit trails, allowing clear visibility to trace results and records. The module can also provide protective security measures to detect and notify any attempt at unauthorised use of passwords and/or identity codes during the audit.

Used in conjunction with Stable Micro Systems' Powder Flow Analyser and other products, the Exponent software is said to be one of the most accurate and reliable methods available for measuring the flow characteristics of dry and wet powders. It helps manufacturers avoid problems with batch and source variation of ingredients, caking during storage, bridging in hoppers and sticking during production. In the pharmaceutical industry, tests on ingredients can be followed by analysis of finished products such as tablets and capsules.

It also enables rapid statistical data analysis and report generation, while pre-set tests allow ease of use for the operator. The facility to write new methods, measure additional characteristics and optimise settings are key additional features.