Did You Know?

Did You Know that today's submission validation criteria are moving beyond the recommended industry standard and that anything from XML files to PDF files inherent in the creation and review of eCTDs require deep analysis? Are you confident that your submission will meet the right standards as requirements change constantly?

The answer is no longer that you can simply have a validation tool at hand which will give you peace of mind. When validating, companies now need to look for solutions that go beyond simply checking against available specifications, but rather seek a complete snapshot of each submission which can be archived and act as proof of what has and has not been checked in the realm of file formats, file structures, naming conventions or the status of bookmarks and hyperlinks.

When defining a dependable validation solution, although profiles for key agencies worldwide such as the FDA, Health Canada, European EMEA and Japanese PMDA should be standard and updated automatically as changes are published by agencies, users should also be able to amend and create their own rules continuously and develop their own profiles based on existing rules. The ability to create and re-use different profiles should also be considered fundamental and essential.

The benefits of dependable validation range from quickly adapting to changing regulations to the ability to assess submission readiness or perform robust life cycle analysis. The consequences of not validating with the right tool could be disastrous in terms of time and cost.

For more information on using what experts hail as the most dependable validator, log onto www.lorenz.cc or call Yaprak Eisinger at 1.866.286.0051






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