In many industries, noncompliance with government regulations can have serious
legal and civil liability consequences. Most compliance solutions- distributing
binders and packets, holding classroom training sessions, gathering signatures on
paper forms, and transcribing the data onto spreadsheets- comprise a manual framework
that companies struggle to control. Tracking of regulatory
compliance training is difficult and reporting is often months behind the curve.
StarCast enables companies to complete their compliance training online. With StarCast, organizations can reduce the costs of compliance and increase control over their operations by providing globally scalable solutions for fully integrated Training Management, Quality Management Systems (QMS), and Electronic Document Management Systems. This helps ensure compliance against the stringent demands of the FDA, ISO and GxP regulatory bodies. In addition, for public U.S. companies, StarCast enables compliance for complex Sarbanes-Oxley Act requirements.
With StarCast you can now manage the entire compliance process online, gather signatures, and produce immediate, accurate, and comprehensive reports for an auditor- all without a single sheet of paper.
StarCast’s eSignature component is an efficient online compliance solution for device manufacturers dealing with government-mandated training and record keeping. With eSignature capability, StarCast allows designated StarCast online training courses, documents, tests, and/or surveys to be earmarked for signature verification. This allows a device sales rep, employee, or physician to acknowledge that he or she has read a document or taken a particular course and fully understands the information that was presented to him or her. Once the user has acknowledged his or her understanding, the signed electronic record is time stamped and immediately entered into the user’s history file. A system administrator can then call on this documentation within seconds through the use of StarCast’s reporting module. Documented evidence can then be made available to an government auditor in minutes. Device compliance training has never been easier. The signed electronic records meet the "electronic signature linking" requirement of the FDA’s Title 21 CFR Part 11.