The ValidSolution for Submissions
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Transforms all files for
submissions into 21 CFR Part 11 Electronic Records
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Workflow Manager streamlines
document creation, collection, review, and approval
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Reusable templates provide
framework for organizing and streamlining the submission process
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STREAMLINE THE SUBMISSION PROCESS
The ValidSolution for Submissions supports 21 CFR
Part 11 compliance and streamlines the process for preparing and filing your
submissions such as FDA 510(k)s and EU technical files through document
authoring, reviewing, editing, approving, versioning and publishing.
ValidSolution 21 CFR Part 11 features including electronic signature,
witnessing, user authentication, and encryption.
AUTOMATES DOCUMENT LIFECYCLE MANAGEMENT
The ValidSolution for Submissions can be
used to support the submission process for both European and US regulatory
agencies. For each submission a
Project Manager defines the required package to be completed.
When the Project Manager issues the submission, it automatically includes
all necessary documents and responsibility matrix.
Documents are accessible from both a desktop client and a web browser.
For each project, the Project Manager
defines the table of contents using the appropriate templates for the submission
package. The submission package is
published by the workflow manager after each of the required sections has been
prepared, reviewed, and approved.
The ValidSolution for Submissions is an
excellent team collaboration tool.
Using a centralized management structure, government recognized encryption
method and integration of current authoring tools, your team can realize
substantial productivity improvement.
IMPROVES SECURITY
To protect your intellectual property,
documents are accessible only to authorized users established and maintained by
the project manager.
A secure audit trail system records all Part 11 mandatory file
transactions and if desired, all other file transactions.
Once a document is approved, it can be updated by creating a new version.
FEATURES
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Holds
documents in a easy to retrieve organized system
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Documents
can be many formats
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Interfaces
are public so other applications can use the system
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Supports
single user or multiple users
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Can be
accessed using Microsoft Explorer or Netscape Navigator or any standard
Browser
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Based on
Lotus Domino Server
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Has
retention scheduling features for easily
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Has
versioning features for easily managing new versions of information
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Has three
definable levels of security providing exactly the level required for your
information
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Easy to
store documents right out of the authoring application it is created or
viewed in
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Easy to
retrieve documents created anywhere in the company
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Documents
can be managed according to your existing policies
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Documents
can be located using standard search criteria
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Integrated
with Windows and your desktop applications
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The ValidWorkflow
document authoring process
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REINFORCES BEST PRACTICES
FLEXIBLE, CUSTOMIZED
INSTALLATION
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The
web interface is intuitive and easy to use |
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