Features Assisting FDA 21 CFR Part 11 Requirements

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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.
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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.

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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.

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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.

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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.

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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.

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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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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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SkyPrep Inc. provides integrated corporate e-learning solutions to help top companies facilitate online training and knowledge sharing in their organizations.

550 Queen Street East, Suite 335
Toronto, Ontario
M5A 1V2