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.

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