Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner 2010

This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.

Description :

Document control can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in compliance with the regulations. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.

Areas Covered in the seminar:

• QSR and ISO 13485 requirements for document control
• Description of typical document control system in use
• Streamlined document control process
• Paper-free document review
• Immediate document distribution

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