Assay development software aids Part 11 compliance

Axela has released dotLab system software that provides technical controls to support compliance with 21 CFR Part 11 regulations. The dotLabs system is used in the development of assays for monitoring protein production and biomarker quantization. Features of the software include a secure database, audit trails, electronic signature controls and user name/password controls.

"The 21 CFR Part 11 Compliance Support Software simplifies implementation of controlled assays and provides dotLab system users with a single platform for development, validation and transfer of assays between labs," says Rocky Ganske, Axela president and CEO, in an announcement.

Part of the difficulty with Part 11 regulation of electronic records is that there is no single way to interpret it, writes Ben Rothke, an information security specialist, in an article in Bright Hub. The intent of Part 11 was to reduce the generation of paper and speed up the regulatory process, all the while preserving the trust held in existing paper-based system. Part 11 is a "first-in-industry trust regulation," he writes, which "seeks to control the basis of denial, ensure the accountability of individuals for their electronic acts, the creation and preservation of electronic forensic evidence and the legal enforceability of electronic signatures and records."

The Axela electronic-records compliance software is part of a suite of tools for the dotLab system, which is based on a proprietary optics technology.

- here's the software release
- read the Bright Hub article

Suggested Articles

There's no evidence personal patient information leaked during the 11-week breach, but the same can't be said about Sangamo's own secrets.

Through a new online tracker, AllTrials names sponsors who fail to report clinical trial results on time per the FDAAA Final Rule.

The new solution aims to streamline the incorporation of human genomic data into clinical trial designs.