The Document and Change Control module is a Master List of all controlled information. With it, you can manage document changes and ensure that all changes are authorized and recorded.
The Document and Change Control module goes beyond documents alone. Instead, it becomes a Master List for any type of data. Think of it as an “electronic catalog” used to organize, manage and control changes (revision control, version control) to any type of information important to your business.
Designed specifically to meet all the requirements of a fully functional document control system as described by quality standards such as ISO 9001, ISO 13485, AS9100, TS 16949 and SQF 2000 / ISO 22000.
QCBD is fully compliant to 21 CFR Part 11 (Electronic Records and Electronic Signature).
QCBD can handle the full range of document types, enabling you to organize and cross reference your information and provide access to that information over a company network while enforcing security and control.
These are some of the typical documents you can control using Master List module:
|Artwork (labels)||Device History Records||MSDS (Safety Sheets)|
|Audit Reports||Risk Analysis (FMEA)||Product Specifications|
|Audit Schedules||Forms||3rd Party Specifications|
|Contract Review||Inspection Plans||Quality Records|
|Control Plans||Job Descriptions||Test Methods|
|Design History Files||Management Reports||Validation reports|
|Design Reviews||Meeting Notes||Work Instructions|
PENDING → ROUTING → APPROVED → RELEASED
TRAINING – Integration with other QCBD modules enables you to link training requirements to document changes. When document changes are released, users are automatically notified by email that training is required.
The Document and Change Control module is a Master List of all controlled information.
Think of it as an “electronic catalog” used to organize, manage and control changes (revision control, version control) to any type of information important to your business.
Your documents are placed in the file attachment section in their native format (Word, Excel, PDF, etc.).
Organize your documents by category.
Security access determines which users can view documents and who can make changes.