operation managements
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analysis and optimizations recommendations of a document center
![Quintiles: Streamlining Document Storage ,[object Object]](https://image.slidesharecdn.com/quintilesomfinalv2-12784267061649-phpapp01/85/operation-managements-1-320.jpg)
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operation managements
- 5. Data Document Center Process Office GCP Storage Room Data Document Center Investigational Sites Record Review Room Sponsors Document Management System CTA Receive Site Regulatory Documents CRA Validate received documents Bar-coding, document IDs, tracking logs, packing in Quintiles delivery boxes, and ship to the Data Document Center via Nittsu express delivery system. ELVIS Record Center Imaging Document Tracking First Delivery and Feed back Filing Review Document Review (QC) Review Delivery Global System Standard Filing Plan of Quintiles SOP Filing Review Automatic Register
- 6. Operations – General Orientation Office area work stations (typical) Work stations (warehouse –like area) Long-term file storage (warehouse-like area) File Delivery Elevator Temporary File Storage (cart) Lounge & Work Area
- 7. Operational Steps & Spatial Layout 1 2 3 4 5 6 7 8 9 Document Reception Validation 1 Validation 2 Imaging GCP Log SSU (database) CSR (excel) Imaging Quality Check Filing 2 1 4 6 3 6 5 7 8 9 3 5
Editor's Notes
- This is the DDC Process. ・ CRA promptly submits received Regulatory Documents. Received documents will be recorded in tracking system and be filed in the GCP storage room. ・ Regulatory Documents will be managed in accordance with Quintiles Global SOP. ・ Core Regulatory Documents will be tracked by Quintiles Global standard tracking system. ・ Documents will be PDF formatted, reviewed and stored by using Quintiles Global Standard Document Management System.
- Notes/Legend: Dashed borders indicate the step has yet to be implemented (step #5). For steps 5 & 6, future plans are to place those functions in the long-term storage area when readied for workspace occupancy (i.e. climate control upgrades). To clarify, step #6 has been implemented but plans are to move the location of the function into the long-term storage area. If arrow or location is indicated in red; meaning is it is a shared location for multiple steps. Steps can be located in two separate areas as indicated.