LMS for FDA 21 CFR Part 11 Compliance

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LMS for 21 CFR Part 11 Compliance
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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 practically always appraised during a regulatory assessment for CFR 21 Part 11 compliance. Even if a business is not directly regulated by the FDA, CFR21 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.

With these features, SkyPrep always keeps your training records updated and inspection-ready.
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Audit Trail Reports

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

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Electronic Signatures

SkyPrep allows electronic signatures for various options such as update course, and delete module. It 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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User Authentication

SkyPrep’s authentication controls 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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For Audit trail documentation, course versioning is a necessity. Hence, any changes made in SkyPrep do not obliterate the previously stored records. Audit trail data is only ever added to and never updated or deleted. It is also always possible to see previously recorded information.

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Login Controls

SkyPrep offers inactivity lockout and limiting login attempts features so that admins are instantly notified and can re-activate user’s account. Access rights to different utilities are achieved by configuring and Permissions and Roles. SkyPrep password expiry feature requires users to change password after a configurable period.

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Data Security

SkyPrep uses an ISO27001 compliant Amazon AWH 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

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

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Inspection-ready on the go

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. These reports can be printed or viewed on screen in a variety of formats, such as HTML, CSV and Excel.

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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