Best Practices for Automating Submission …...Dashboards for Management and Company Meetings...
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1 Best Practices for Automating Submission Processes & Reporting Janine Segich Director, Regulatory Operations
Transcript of Best Practices for Automating Submission …...Dashboards for Management and Company Meetings...
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Best Practices for Automating Submission Processes & Reporting
Janine SegichDirector, Regulatory Operations
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Disclaimer
The views and opinions expressed in this presentation are solely those of theauthor and do not reflect the official policy or position of InterceptPharmaceuticals, Inc.
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About Intercept
§ Focused on the development of therapies to treat chronic liver and intestinal diseases
§ Rapidly growing – Grew from <50 to >400 in two years– Currently have > 200 full users in Vault Submissions– Three offices (San Diego, New York & UK)
§ Utilizing Veeva across a number of areas– Submissions, QualityDocs, PromoMats, MedComms, CRM
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Agenda
1. Moving from manual to automated2. Importance of measurement3. Connecting systems
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Typical Manual Folder Structure
ORIGINALS
IN REVIEW
IN FORMATTING
APPROVED
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Recommendation: Institute Processes Within Workflows
Each process gets a dedicated workflow and lifecycle:
§ Editing
§ Quality review
§ Formatting
§ Approval
Usage is Mandatory
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Sample Lifecycle
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Lifecycle States
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Reflecting the Business: QC Workflow
§ QA/QC workflow separate from editing or review workflows– Identify specialized QA/QC group
– QA/QC review focus
• Editorial
• Internal consistency (Content/Data)
• External consistency (Content/Data)
• Data/Numbers Only
– QA/QC review types
• Abbreviated (portion of the document)
• Full (all of the document)
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Reflecting the Business: Formatting Workflow
§ Formatting workflow separate from editing or review workflows– Identify a specialized formatting group
– Authors can initiate formatting workflows
– Document the appropriate completion • Formatting complete (document is locked and ready for approval)
• Formatting partially complete (document stays at draft)
• Formatting not complete
§ Regulatory Ops has “super user” permissions to help assist authors
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Classifications for Correspondence
§ Region-specific correspondence classifications enable downstream searching and reporting
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Once in System – Must Get People Using It
SOP TrainingAn ongoing
process
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Importance of Measurement
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Reporting Examples
§ Reporting for initial IND or NDA/MAA– Creating a report for each module– Reports should be easily configurable– Export to Excel with hyperlinks
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Reporting for Different Needs
§ Module reports for sub teams§ Reports for inspections or due diligence§ Reports for submissions
– Submission log by application– Based on the metadata
§ Reports for correspondences– Correspondence log by application– Based on application + classification
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Dashboards for Management and Company Meetings
Module 1 Module 2 Module 3
Module 4 Module 5
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Dashboard Options for Different Uses
Note: If document needs to go back to draft –it MUST be re-worked within the system.
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Connecting Your Systems(Key to Automation)
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eDMS to PleaseReview for Collaborative Authoring
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eDMSPleaseReview
Real-time co-authoring
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eDMS to eCTD Publishing system
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DraftApprovedPublished
eDMS
