LMS for FDA 21 CFR Part 11 Compliance

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SkyPrep LMS Features in Accordance with 21 CFR Part 11

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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.

In organizations, training records are almost always appraised during a regulatory assessment for CFR 21 Part 11 compliance. Even if a business is not directly regulated by the FDA, CFR 21 is still an accepted standard for e-signatures, inspection, and recordkeeping. Hence, it is essential for your corporate LMS to have the features in accordance with CFR 21 Part 11.

SkyPrep always keeps your training records
updat-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 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 notified instantly via inactivity lockout and limited login attempts features. Access rights to different utilities are achieved by configuring and Permissions and Roles. With password expiry feature,password can be changed after a configurable period.

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User Authentication

Authentication controls in SkyPrep LMS require User ID and password. All users are assigned unique user IDs that make it easier 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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Most User-Friendly LMS

SkyPrep has an easy-to-use and customizable interface. Therefore, it is recognized as a smart solution for FDA CFR21 Part 11 compliance.

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Best Customer Support

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

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Inspection-Ready 24/7

SkyPrep keeps all training records updated in real-time for hands-on compliance reporting. Hence, organizations can be inspection-ready 24/7.

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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!


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

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Toronto, Ontario
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