Tag Archives: Title 21 CFR Part 11

Surprisingly Cool Things You Can Do with an LMS

Surprisingly Cool Things You Can Do with an LMS

Surprisingly Cool Things You Can Do with an LMS

Not all Learning Management Systems are created equally. In fact, you would be hard pressed to identify matching features across the entirety of the industry. So instead of "Surprisingly Cool Things You Can Do with an LMS" this article may be more aptly titled, "Things You Did Not Know GyrusAim Could Do for You". However, it is best to gaze upon this list with the intent to evaluate your current LMS, as it too may have some of these capabilities hidden within its standard operating features.

Resource Management

The number one item on our cool stuff list is Resource Management. Having the cooperative capabilities to schedule an instructor on a localized calendar has unmeasurable benefits. Scheduling that same instructor, the classroom, the projector he/she is using, a laser pointer and a shared laptop… priceless. One of the smarter features of an intuitive LMS is being able to fully manage all aspects of the learnings; this includes considerations for conflict management and making sure administrators are not double or triple booking training resources within their organization. This practice also aids in the ability to reschedule due to unforeseen circumstances, as well as to track user metrics within the allotted scheduled times.  

Custom APIs

The second cool thing we find that is typically overlooked is the ability to develop custom APIs. What is an API? According to Beal (2016), an “Application program interface (API) is a set of routines, protocols, and tools for building software applications. An API specifies how software components should interact.” If your organization has developers on board with some time to spare, and you as a training organizer has requirements for interactivity between common programs, an API could be developed to ease inoperability between software components. This could be as simple as integration with your HRIS to as foreign as merging the capabilities of two separate Learning Management Systems.  

Assessment Creation Tool

You are definitely reading that correctly. The ability to generate content directly into the LMS not only exists but is being highlighted on this blog post. Gone are the ways of the past and the need to call your LMS provider every time you need a new bit of content development. If your organization demands an immediate change, an external time component in unnecessary, and the inevitable reception of a bill to reflect that proposed demand can be completely averted. In today’s marketplace organizations need to be able to address their own needs, without cost prohibitive circumstances surrounding their LMS.

Granular Control

When we say granular control at Gyrus Systems, we mean granular control. With 258 permissions currently available in GyrusAim and the ability to define new user roles within the program with just a click of the mouse. Undoubtedly other LMS providers also share at least a portion of these restrictions. Administrators are often unaware of what they are capable of divulging to their users within these settings. Perhaps, there is a view that would add exponential user value or one that would allow for a subroutine to be performed by another role in your department, making your work life infinitely easier.

Title 21 CFR Part 11

Unless it is an organizational requirement, you may not be aware of its availability. At Gyrus, we pride ourselves in being 21 CFR Part 11 compliant. If you are asking yourself what is 21 CFR Part 11, it is defined as, “Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a))”  [Wikipedia]  GyrusAim has developed a feature for supporting compliance with Title 21 CFR Part 11. Though your LMS may not support this particular requirement for electronic signatures, there may be an alternative compliance component that can be utilized for security purposes within your current environment.

Thus concludes this segment of Surprisingly Cool Things You Can Do with an LMS. Please continue to join me as I investigate the LMS landscape and offer helpful tips whenever they may arise.  

 

References

Beal, Vangie. "What Is API – Application Program Interface? Webopedia Definition". Webopedia.com. N.p., 2016. Web. 14 June 2016.

"Title 21 CFR Part 11". Wikipedia. N.p., 2016. Web. 14 June 2016.

Gyrus Systems releases GyrusAim r15.1 – Title 21 CFR Part 11

Richmond, VA, August, 10, 2015. Gyrus Systems, a leader in the Learning Management Systems (LMS) industry is pleased to announce that the latest “15.1” release of the GyrusAim LMS is now available.  This is the second major release of the year and contains many innovative features that help both Learners and Training Managers.  These GyrusAim features include brand new easy-to-use Setup Wizards, Title 21 CFR Part 11 security and eSignature functions, Integration with Skillsoft’s Open Learning Services Architecture (OLSA), as well as enhanced Assessments, Course Catalogs, and Reports. See below for highlights.

GyrusAim Highlighted Features

Wizards – Brand new Wizards simplify and speed up adding eLearning, Webinars, Assessments, and Courses & Classes.  For example, when using the Course & Class Wizard a course can be quickly entered and multiple classes scheduled with just a few mouse-clicks.  Likewise the process of creating Assessments using the Wizard takes a user step-by-step through the process, making this process more streamlined and intuitive for Training Managers. 

Title 21 CFR Part 11 – Data security is extremely important.  With this fact in mind, Gyrus Systems created new technical controls for the FDA's Title 21 CFR Part 11 compliance requirements.  This is good news for FDA-regulated industries such as pharmaceutical companies, medical device manufacturers, biotech, and other such businesses because training records are more secure, electronic signatures are validated, and changes made to all data is completely and automatically audited when Part 11 features are configured.  

 My Profile Menu – The My Profile menu has been redesigned to provide metrics-at-a-glance for all learner training data.  Users can access the new My Profile with a single mouse-click and view all aspects of their training progress in a real-time environment that shows their latest statuses.  They can click to drill down into the data for a deeper analysis and to take actions when necessary (like taking eLearning, or enrolling into Instructor-Led classes) achieving a fully-interactive LMS experience.

Assessments – Dramatic improvements to both functions and the user-interface make creating and taking assessments much easier.  Improvements such as shared questions, images on questions and answers, streamlined workflow, and the new Assessment Wizard mentioned above achieve an outstanding level of customer usefulness.   

More – Advances to the Course Catalog, Skills, and Reports round out this release as a very important milestone on the GyrusAim product roadmap.

 

About Gyrus

Gyrus Systems is a stable, privately-owned company which produces the one-stop LMS solution for many clients worldwide.  Since 1987, 450+ companies in 15 countries have utilized Gyrus Systems’ learning management technologies making them more efficient, more productive, and contributing to a greater success of the organization. The company is headquartered in Richmond, Virginia.  For more information, please visit http://www.gyrus.com/.

 

GyrusAim r15.1 LMS and Title 21 CFR Part 11

21 cfr checkRelease 15.1 of the GyrusAim Learning Management System (LMS) is now available and includes technical controls for the FDA's Title 21 CFR Part 11 compliance for both open and closed systems.  This is good news for FDA-regulated industries such as pharmaceutical companies, medical device manufacturers, biotech, and other such businesses because training records are more secure, electronic signatures are validated, and changes made to all data is completely and automatically audited when Part 11 features are implemented.  

See Title 21 CFR Part 11 Regulations for FDA regulatory details and our July 16th, 2015 blog for background information.

 

Review below for selected Part 11-related enhancements:

  • Data validation to ensure accuracy, reliability, and identification of altered records by requiring a unique two-level security process by individuals when adding, changing, or deleting information.
  • Recording of secure, time-stamped and computer-generated audit trails related to data modifications noted above.
  • All security steps are required when an individual executes one or more electronic signings not performed during a single, continuous period of controlled system access.
  • Each combination of username, password, and PIN are unique to specific a individual.
  • Electronic signatures contain all information required such as printed name of signer, date & time when signature executed, and the meaning of the signature via selection of a company-defined reason code.
  • Completely configurable based on company’s definition of what records require Part 11 authentication.
  • Resetting of PINs for all or selected users can be scheduled or manually updated so that periodic checking, recalling, or revising of security data is manageable.

 

More features included for overall improved security:

  • Immediate notification of attempts to breach system security.  Such notifications require management review and are included in the Part 11 audit trail.
  • Entire system can be locked down in seconds if necessary, preventing data manipulation from occurring in the case of a security breach.

 

These GyrusAim features allow training records to exist in a highly secure Title 21 CFR Part 11 business environment.

Request a demo using the "Request Demo" button to the right for more information about how GyrusAim can help manage the training programs of not just Title 21 CFR Part 11 regulated companies, but all companies!

Ensuring 21 CFR Compliance with GyrusAim LMS

21 cfr checkTechnology has so greatly improved the ability to track and verify training records and certifications via digital signatures that physical records and handwritten signatures are rare in today’s business environment.  To define the trustworthiness of such electronic signatures the FDA created Title 21 of the Code of Federal Regulations Part 11 which sets the standards and regulations of electronic records and electronic signatures for organizations in bio-technology, medical manufacturing, pharmaceutical, healthcare and other FDA regulated industries.

Issued in 1997, Title 21 CFR Part 11 allowed digital records and signatures to be equivalent to their handwritten counterparts while creating official methods that organizations must use to maintain and electronically submit them to the FDA.  If all electronic records met these requirements then the signatures are officially accepted.

Requirement Highlights:

 

  • Validation to ensure accuracy, reliability, consistent performance and the ability to discern altered records.
  • Ability to generate accurate and complete copies suitable for inspection, review and copying.
  • Protection of records.
  • Limiting system access to unauthorized personnel.
  • Use of secure, computer-generated, and time-stamped audit trails to independently record the date and time of entries and actions that create, modify or delete electronic records.
  • Use of operational systems checks to enforce permitted sequencing of steps and events.
  • Use of authority checks to ensure that only authorized individuals can use the system.
  • Use of device checks to determine the validity of the source of data.

 

How GyrusAim Measures Up

 

Non-compliance during regulatory inspections can risk damaging your company’s integrity and reputation.  Only a handful of learning management system (LMS) providers offer organizations the ability to meet the FDA’s Title 21 CFR Part 11 requirements.  With the July, 2015 “15.1” release of GyrusAim, Gyrus Systems will be part of this select group of LMS providers.

Included in GyrusAim r15.1 are integrated features that thoroughly permit your company’s Title 21 CFR Part 11 compliance.  When enabled they assure compliance by adding an additional layer of security tracking and auditing of any change to GyrusAim data.  All access and functions within GyrusAim are controlled by user identifications and passwords, ensuring audit-trails are properly recorded for every user.  Additional built-in features are included such as on-screen warnings to managers, manager authentication of warnings, instant de-authorization of individual or all user logins by managers when a violation occurs, and more!

With Gyrus Systems’ Learning Management System, GyrusAim, you will have access to these key features to help you manage you 21 CFR Part 11 compliance:

  • Auditing
  • Electronic Training Records
  • Electronic Signatures
  • Reporting
  • Version Control
  • Secure Hosting options-SaaS or Self-Hosted

For more information or to request a demo please visit our website.