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Site Development by: Web
Completors © 2003-2007 All rights reserved. Nothing in this site may be copied
or duplicated without written permission. |
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| 3-Phased
Approach
- Pre-Assessment Review (PAR) -- Definition of opportunity, Readiness
and Scope
- Proof of Concepts -- Initial Redesign, Documentation Guidelines,
Pilot Testing, Change Control and Implementation
- Time Required: 8-13 weeks
- Redesign & Harmonization – Redesign and harmonize
remaining documents, Pilot Testing, Change Control and Implementation
- Time Required: 13-16 weeks
The Benefits
See results following a thoroughly assessing and challenging
of the current documentation -- then simplifying and eliminating
all unnecessary, superfluous and redundant content that was not
required for process control or cGMP reasons.
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| Reductions
| Documents |
10 - 25% |
| Pages |
30 - 50% |
| Entries |
30 - 60% |
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