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As 21 CFR Part 11 requires ongoing attention in order to maintain compliance,
iMarkup Solutions is delivering software allowing its clients to address the
requirements of this regulation. Further, iMarkup Solutions understands that
interpretations of FDA Title 21 CFR Part 11 may differ from company to company
and sees this as an opportunity to continue to build on its 21 CFR Part 11
compliance portfolio.
It is iMarkup’s commitment to provide its clients with the best technology
solutions for document management and workflow. The senior management
of iMarkup Solutions will make every effort through good technology practices
and internal operating procedures to develop and utilize systems which comply
with interpretations of 21 CFR Part 11, and enable customers to establish compliance.
The regulation’s premise is to maintain proper identifiers for electronic data
relevant to product safety, purity and efficacy. Just as printed documents
provided a paper trail through the product life cycle, computer records need
to create a similar electronic trail, identifying users, approvals and
progressions that lead back to the original data.
iMarkup Server provides comprehensive security management and auditing
features that enable your organization to maintain compliance with 21 CFR Part
11.
- User authentication supports your existing compliant security systems
(e.g. Windows Domain Security, Windows 2000 Active Directory, LDAP, etc.);
- Only authorized uses have access to sensitive information;
- A predefined, automated workflow process provides consistent review,
approval and update procedures for all content;
- Document version control maintains the identity of any user who modifies a
document;
- A document history maintains every workflow run against a document,
showing not only who updated a document, but who reviewed it, what their
comments where and who approved the changes;
- Detailed auditing logs provide a complete audit trail of all users’
activities and system events for reporting and audit purposes;
- All document updates and approvals requiring
electronic signature are re-authenticated;
- User IDs can only be logged in from a single location at a time;
- Approval hierarchies can be established for document changes and updates;
- Software upgrades will not modify configuration parameters or settings on
the existing system;
- All comments and annotations made to a document are identified by user and
time;
- Access control lists allow security permissions to be established for the
read, write, and delete of documents, preventing users with write permission
from deleting archived documents;
- Automatic workstation logoff ensures inactive sessions require
revalidation through authentication system to continue working;
- All security, permission or access changes are audited;
- All documents, workflows, permissions, etc. are stored in an enterprise
database with documented schema allowing independent access, backup/restore,
reporting, and administration.
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