Proposal for ectd Publishing Solution

Size: px

Start display at page:

Download "Proposal for ectd Publishing Solution"

Chester McDaniel
6 years ago
Views:

1 Proposal for ectd Publishing Solution COURT SQUARE GROUP LORENZ LIFE SCIENCES GROUP REGDOCS365 LLC SAGE SUBMISSIONS 17 OCTOBER 2016 FINAL

2 IPEC-Americas ectd RFP IPEC-Americas members are interested in learning if your organization would consider offering either a fixed rate or a percentage discount (as appropriate) for ectd conversion services/conversion software for IPEC- Americas member companies... [to meet the] time lines for conversion of paper Master Files to electronic ectd format. [T]he US FDA s regulation is scheduled to go into effect May 17*, *deadline is May 5, 2017

3 ectd Creation & Submission Process 1. MS Word skills & templates 6. Electronic Submission Gateway (ESG) 5. ectd compilation & Validation Compliant ectd submission 4. Secure content repository (EDMS or file share); 21CFR11 2. Adobe Acrobat PDF conversion 3. Adobe Acrobat PDF remediation tools & skills

4 IPEC-Americas Unique ectd Solution Complete ectd solution Authoring Document management Publishing Validation Submission via ESG 12-month commitment by IPEC-Americas member Invoiced quarterly Deployed in the Cloud

5 IPEC-Americas Unique ectd Solution User licenses Unlimited use MS Word ectd templates Unlimited use PDF Rendition server 2 MS Word 2 Adobe Acrobat Professional 2 ectd publishing 2 document management users 1 FDA ESG/Health Canada CESG production account Additional licenses/certificates/accounts may be added With initial configuration At the beginning of any month

6 IPEC America Unique ectd Publishing Solution - FDA secure - Electronic signature - Digital Certificate (s) - Implement production account 1. MS Word skills & templates Sage Templates for FDA DMFs & Self-Paced Training Health Canada DMF option LORENZ docubridge for FDA DMF with LORENZ evalidator Health Canada DMF option & LORENZ HC evalidator option 6. Electronic Submission Gateway (ESG & CESG) 5. ectd compilation & Validation RegDocs365 with EDM Reference Model configuration for DMFs Compliant ectd submission 4. Secure content repository (EDMS or file share); 21CFR11 2. Adobe Acrobat PDF conversion 3. Adobe Acrobat PDF remediation tools & skills Adlib PDF Enterprise server with OCR Adobe Acrobat Professional TRS Toolbox Pharma Edition option All components hosted at facility in Marlborough, MA managed by Court Square Group

7 Cost Proposal Component RegDocs365 - Unlimited use ectd templates - Unlimited use Adlib PDF Enterprise + OCR - 2 MS Office 365 Business - 2 Adobe Acrobat Professional - 1 Digital Certificate - Symantec Endpoint Protection - EDM Reference Model for Regulatory Submissions - Training Monthly Cost $1,032 LORENZ docubridge $1,960 Total $1992

8 Discounts RegDocs365 EDM Reference Model for Regulatory Submissions 25% Sage Templates 25% then amortized over 12 months docubridge pricing unique to IPEC-Americas

9 Our Proposal Unique/Total ectd publishing solution exclusive to IPEC-Americas members Assumptions Members wish to perform their own ectd publishing IPEC-Americas members wish ability to prepare ectd submissions for FDA with Health Canada option Members do not have IT staff to implement the system components in-house Members wish to be compliant with 21CRF11 Joint Venture to provide the unique/total solution Court Square Group, Inc. Lorenz Life Sciences International RegDocs365 LLC Sage Submissions Each member of the Joint Venture may also submit a proposal to IPEC Americas At the discretion of each individual vendor Discounts Configuration(s) Outright purchase vs quarterly billing Etc.

10 Joint Venture Leadership Team Keith M. Parent, Chief Executive Officer Court Square Group, Inc. Mobile Yaprak Eisinger Vice President, North America Lorenz Life Sciences Group Mobile Keith M. Parent, Co-Founder RegDocs365 Mobile Antoinette Azevedo, President Sage Submissions Mobile Hector D. Trestini Director, Client Services, North America Lorenz Life Sciences Group Mobile Antoinette Azevedo, Co-Founder RegDocs365 Mobile

11 Questions & Next Steps ANTOINETTE AZEVEDO MOBILE OR

ectd in Canada Ginette Larocque, Purdue Pharma Canada August 23, 2016

ectd in Canada Ginette Larocque, Purdue Pharma Canada August 23, 2016 AGENDA Eligibility for Filing in ectd Format ectd Mandatory? Structure and Content LCM Table and HC-SC 3011 Form Info Module 1 Administrative