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“During the 100 years of the
20th century, the human race lost
more information than it gathered
during the previous 100 centuries”
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Thomas Quinn, President
Records Continuity, Inc. Nov 1999
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The Hollis Group, Inc. has been
actively involved in researching the problems associated with e-Archiving and
e-Restoration for over a decade.
We have a particular interest in the
challenges associated with the raw data generated by clinical research,
laboratory instrument, and process / SCADA systems.
Please stay tuned to this page for some
forthcoming major announcements on how we can help you handle the exponentially
growing e-Archives that your organization is generating.
In order to get you started, we've
included some of our earlier research:
The Hollis Group would like to thank PDA for graciously granting permission to place this work in the public domain by allowing us to submit it to the FDA public docket covering 21 CFR 11 and related guidances.
(This article was submitted to docket 00D-1539, "Electronic Records & Electronic Signatures, Retention of Electronic Records", on FRI 04 OCT 2002.)
This article includes Hollis's earliest thinking on the subject of e-Archiving. Note that it takes a very document-centric view of the problem. It completely avoids raw data and restoration.
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This report includes the results of our ground-breaking research
into industry preparedness for e-Archiving and restoration. We like to
think that this report was on of the principal motivators for the
formation of the e-Archiving task group of the Industry Coalition on 21
CFR 11.
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Bragging Here!
In the Fall of 2001, The Hollis Group, Inc. conducted
a training session for the e-Archiving task group of the Industry
Coalition on 21 CFR 11.
Please note that the presentations have a seriously
draconian copyright disclaimer. Hey, we're nice folks, but we're not
THAT nice! At the time, we were auditioning to assist the task group.
They went with different consultants, and we hope that this stuff was
not the basis of our competitor's windfall. Feel free let us know,
either way.
Also feel to use these files personally, as long as
you don't re-publish them, teach any classes with them, or re-print
them. You'll find this somewhat difficult anyway, since they're locked .pdf's
Lastly, note that our current training (See below -
Reasonable rates, Cheerful service!) has significantly more content and
much more recent information on proposed solution architectures!
We've also added a complete section that exhaustively
covers the latest FDA "Records Maintenance" guidance.
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We teach a comprehensive course on the subject of e-Archiving and e-Restoration. It includes a definition of the problem, scope research, industry readiness, technology overviews, and a review of several proposed solution architectures.
e-Archiving and e-Restoration for Regulated Systems
(1/2 Day Course - Call for details)
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