Features Assisting FDA
21 CFR Part 11 Requirements

FDA 21 CFR Part 11 Requirements list

SkyPrep Security and Compliance Features

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FDA 21 CFR Part 11 focuses on the security and confidentiality of customer information, administration of e-documents, and the approval requirements for e-documents and signatures.

SkyPrep always keeps your training records
up-to-date and inspection-ready

Audit Trail Reports

Audit trail reports provide a read-only record of any updates pertaining to system-critical objects. Every audit trail report specifies the event, date/time, affected data object, operator identification, type of change, and comments.

Versioning

For audit trail documentation, course versioning is a necessity. Any changes made in SkyPrep are stored without altering the previously stored records, making it possible to see previously recorded information.

Electronic Signatures

SkyPrep offers configurable electronic signature options that enable adding a full user name, unique ID, date, time as well as meaning of the signature when it’s captured.

Login Controls

Admins are instantly notified with inactivity lockout and restricted login attempt features. Access rights to different utilities are achieved by configuring different permissions and roles.

User Authentication

Authentication in the SkyPrep LMS require a user ID and password. All users are assigned unique user IDs that make it possible to track the actions of every user.

Data Security

SkyPrep uses an ISO27001 compliant Amazon AWS hosting service and provides consistent backups of customer information. The user data is protected by SSL.

Why Choose SkyPrep

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Most User-Friendly LMS

SkyPrep has an easy-to-use and customizable interface that customers love.

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Best Customer Support

Our team provides all of the necessary onboarding, training and help resources. The exceptional customer support team is always ready to assist users.

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Inspection Ready

SkyPrep keeps all training records updated in real-time for hands-on compliance reporting.

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Robust Reporting

SkyPrep provides audit and compliance reports, including a “Record of Learning” for each user, that offers a full historical transcript of learning for that user.

Improve your online training today with SkyPrep!

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