Helix ALM is software which provides a multitude of capabilities to its clients, including the enforcement of regulatory compliance requirements such as the Sarbanes-Oxley Act, which is also known as what in the Senate?
Helix ALM Helix ALM, formerly called TestTrack, developed by Seapine Software, provides a centralized suite of capabilities for managing requirements, defects, issues and testing throughout the software development cycle. This suite tracks everything involved in the software development process from feature requests and requirements to design revisions and actual changes in the code. It keeps track of what tests were done, what was tested, who performed the test and when, on what platform, under which configuration and in what language. It offers the ability to create, manage, and link artifacts from the beginning through the end of a design and development project providing end-to-end traceability of all development artifacts and giving managers a better handle on the shifting requirements that define their projects. It enforces regulatory compliance to meet regulatory compliance requirements, including 21 CFR Part 11 and Sarbanes-Oxley.
Drug Quality and Security Act The Drug Quality and Security Act ( ) is a law that amended the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs. The bill was written in response to the New England Compounding Center meningitis outbreak that took place in 2012, which killed 64 people. The bill was signed by President Obama on November 27, 2013.