Validation, Documentation, and Training Services
 Thorough validation and documentation of IT
systems now is more important than ever. Sarbanes Oxley and similar
quality and financial compliancy programs have made long term documentation not
just a need, but a necessity for many enterprises.
Given that all IT systems go through changes and (eventually) replacement, even
companies out of the federal auditors' spotlight are well advised to put high
priority on the documentation of their systems.
At attention-to-details, documentation is not just an afterthought. We
continually document as we go with well-documented code and
use a proprietary application (developed in-house) to
create MS Word documents and Powerpoint presentations containing screenshots
with running written commentary; usually at least two complete sets (one for
end users, another for fellow developers).
During larger projects, we create documentation weekly to collect feedback and
make sure everyone is on the same page.
Strong language and communication skills allow us to quickly create many
different types of documentation including:
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User Manuals
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Installation Guides
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Training Materials
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HTML help pages
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Requirements documents
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Adobe Acrobat documents
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Validation protocols
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Quality Assurance documents
Due to recent project work at an implantable medical device company, we
also have specialized knowledge in 21 CFR Part 11 and Quality System Regulation
(QSR) and its effects on creating compliant systems and documentation. We are also
familiar with the SOX (Sarbanes Oxley) signature and security requirements
and have written documents targeted for federal audits.
Good documentation stands the test of time... and is still appreciated years
later!
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