| CONNECT-THE-DOCS®
(C-T-D®) creates paper masters that can be
printed, sent to your electronic document management system (EDMS)
or printed as lot specific records to be used on the manufacturing
floor.
All documents are maintained in a controlled database that notes
when the document is accessed for any reason by creating an audit
trail that identifies user, date and time, and type of change/transaction
that took place.
Why Simplify with C-T-D®?
- Because it is an unmatched solution and:
- Meets all 21 CFR 11 Requirements for passwords, access,
audit trails and Archiving
- Creates new documents in 10 to 20 percent of the time it
normally takes
- Makes simultaneous changes to multiple documents quickly
and easily
- Documents are built using a library of work instructions
(building blocks) that contains variable parameter fields
for process or product specific information
- Ensures documentation content consistency through the use
of building blocks and process templates
- Archives all master documents
Type of Documents we have simplified:
- Quality Assurance Documentation
- Manufacturing Batch Records or Device History Records
- Standard Operating Procedures
- Work Instructions
- R&D Documents
- Engineering / Tech Specifications
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| The impact of our program: |
- 30 - 50% reduction in pages
- 30 - 60% reduction in entries
- 50 - 80% reduction in documentation / procedural errors
- 40 - 70% reduction in review cycle time
- 30 60% reduction in product release cycle time
- 15 - 20% reduction in manufacturing cycle time
- 20 - 30% reduction in investigation time
- 25 - 40% reduction in document creation / revision time
- 10 - 25% reduction in number of documents
- 20 - 30% reduction in training time
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