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:
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
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 textNote: From V2.1, dated 20 December 2011. Original available fromhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm163181.htm
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
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
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
eCTD Requirements – OtherGuidance 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 fromhttp://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163565.pdf
Two types of Compliance Electronic Submission (eCTD) Control over Electronic Records and Signatures
What the FDA (and other Regulatory Bodies) WantYou MUST demonstrate control over your data • Who enters data • How data is modified • Data can be accurately retrieved • Data can be easily retrieved • Documented processesDon’t forget:If you didn’t document it, it didn’t happen.
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.
Documentation and ProcessIn 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
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
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.
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
Additional resourcesYou can find this presentation as well as some additionalresources in your USB Key: 1. Roche Case Study 2. PDF Enterprise Data Sheet 3. PDF Enterprise Technical White Paper