In the medical device industry, 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 most medical device companies struggle to control. Tracking of regulatory complaince training is difficult and reporting is often months behind the curve.

StarCast enables medical device 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.

eSignature

StarCast’s eSignature component is an efficient online compliance solution for medical 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 medical 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 admin 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 FDA auditor in minutes.  Medical 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. More information about StarCast’s FDA Title 21 CFR Part 11 compliance capabilities is available upon request.

 

StarCast eLearning Compliance Capabilities

  • The elearning system allows administrators to change all passwords, system wide, on a periodic basis.

  • The elearning system contains a time-stamped and unalterable audit trail that records the date and time of user entries that create, modify or delete electronic records.

  • The elearning system allows the generation of accurate and complete copies of verification records suitable for inspection, review and copying by the FDA.

  • The elearning system allows administrators to establish automatic distribution lists for online training courses, documents, tests or surveys. Upon significant update of content, the system administrator may direct the system to automatically redistribute the revised content to those on the distribution list for re-verification.

  • Access to the elearning system is by role-base authority.

  • Version-Control allows the elearning system to time-stamp exactly which version of an online training course, document, test or survey the user read, viewed or listened to, and to permanently link that version to that user's history in a way that the user cannot readily repudiate the signed record as not genuine.

  • Version control allows you to verifiably remove (or prevent from use) obsolete online training content from circulation, while maintaining historical documentation.

 

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