Are you in the pharmaceutical industry? Do you have to submit documents for regulatory compliance? Check this presentation to understand the art of avoiding the re-submission to regulatory bodies.

1. The art of avoiding the ‘Resubmit’
Compliance with FDA eCTD 2.1 and FDA PDF Specification 3.1
© ADLIB 2012. THIS SLIDE PRESENTATION CONTAINS PROPRIETARY AND/OR CONFIDENTIAL INFORMATION.

2. Who is Adlib?
• Adlib provides the rendering technology behind
docuRender
• Adlib also licenses rendering technology to a number of
well-known partners and ECM Vendors:

3. New specifications eCTD 2.1 and FDA PDF 3.1
• FDA has made its specifications for eCTD Validation
Criteria Version 2.1 available on their web site.
• Effective within 30 Days notice of FDA deploying new
validation software currently in testing.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm163181.htm

4. eCTD Requirements - Access
• No. 3102: Failed to process PDF Contents
• No. 5057: Document contains no text
• Scanned images must be processed via OCR to provide a text
layer. Related to the intent of 5020
• No. 5020: PDF Security Used
• Reviewer should be able to copy & paste text
Note: From V2.1, dated 20 December 2011. Original available from
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm163181.htm

5. eCTD Requirements - Usability
• No. 5100: Broken Bookmark
• No. 5101: Corrupt Bookmark
• No. 5200: Broken Hyperlinks
• No. 5201: Corrupt link
• No 5217: Link does not ‘Inherit Zoom’
• No. 5005: Non standard font not embedded
• Replaces No. 5000 restriction on Non-Standard Fonts

6. eCTD Requirements - Usability
• No. 5102: Bookmark Has non-existent named destination
• No. 5202: Link has non-existent named destination
• No. 5210: Inactive Hyperlink
• No 5203: Multiple Action Hyperlink
• No 5215: Non-relative Hyperlink
• No Absolute references

7. eCTD Requirements - File
• No. 1255: Invalid file Extension
• No. 1298: File does not contain file extension
• No. 5035 PDF version of document is incorrect (1.4-1.7)
• Restricted to ISO-32000:2008 specification of 1.7, no Adobe
Extensions, equivalent to Adobe Acrobat 8.0
• No. 5029: Misnamed form

8. eCTD Requirements – Other
Guidance from FDA PDF Specification
• Proper Resolution (600 DPI Recommended)
• Page Orientation (Correct for reading)
• Page Size (Letter)
• Margins (.75 inches/19 mm) on Left)
Note: From V3.1, dated 20 January 2012. Original available from
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163565.pdf

9. Two types of Compliance
Electronic Submission
(eCTD)
Control over Electronic
Records and Signatures

10. What the FDA (and other Regulatory Bodies) Want
You MUST demonstrate control over your data
• Who enters data
• How data is modified
• Data can be accurately retrieved
• Data can be easily retrieved
• Documented processes
Don’t forget:
If you didn’t document it, it didn’t happen.

11. Documentation and Process
It is critical to ensure that not only
your own organization complies
with these regulations but also
that your suppliers have your
compliance in mind.
Adlib has been working with
Pharmaceutical customers for
years and have been an active
partner in ensuring successful
submissions and compliance.

12. Documentation and Process
In order to document our compliance, Adlib Software has in
place:
• Compliance Statement
• Quality Manual
• Procedures for
• Documentation Control
• Internal Software Testing
• Software Release
• Responding to Supplier Quality requests

13. Compliance with 21 CFR 11/Annex 11
• Accurate Record Generation
(21 CFR 11.10(b), Annex 11.8 Printouts)
Adlib creates true and accurate copies of all data formats
• Limited System Access
(21 CFR 11.10(d), Annex 11.12 Security)
Adlib PDF limits system functionality to authorized users

14. Compliance with 21 CFR 11/Annex 11
• Audit Trails
(21 CFR 11.10(e), Annex 11.9 Audit Trails)
Adlib PDF Enterprise records all user initiated actions that modify
data.
• Operational System Checks
(21 CFR 11.10(f)), Annex 11.5 Data
Adlib technology performs internal checks to ensure correct and
secure processing of PDF files.
• Authority Checks
(21 CFR 11.10(g), Annex 11.12 Security)
Adlib PDF Enterprise verifies the identity of Users before performing actions that
can modify data.

15. Validation
• Software Validation
21 CFR 11.10(a), Annex 11.4 Validation
• Adlib technology is designed to be validated to demonstrate
compliance with 21 CFR 11 and Annex 11
• Software updates can be validated according to defined
procedures.
• Validation package available for purchase

16. Additional resources
You can find this presentation as well as some additional
resources in your USB Key:
1. Roche Case Study
2. PDF Enterprise Data Sheet
3. PDF Enterprise Technical White Paper