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Post by Dimitri Stamatiadis on Apr 2, 2016 12:21:28 GMT
Dear all,
I have had some interesting discussions lately about PDF rendering with one of our members. The question is "should an EDMS tailored for small companies, necessarily include PDF rendering capability?". The argument was that this is beyond document management and adds a cost (server-based rendering is more expensive than local machine functionality which is embedded in MS word and in the printing functions). On the other hand, PDF rendering has always been a functionality included in traditional EDMS (and admittedly a practical one).
We would very much like to hear from the group if we should maintain the requirement in the Pocket EDMS URS. For information there are currently two requirements. The first mandates that PDFs must comply with specifications provided by the FDA and other agencies and the second prohibits font substitution (as this could create problems with displaying special characters or change the pagination).
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Post by Steve Scribner on Apr 4, 2016 14:30:59 GMT
In my opinion, this is an essential requirement for today's Pocket EDMS. This is the standard format for communications with all agencies. Pharma will expect it and the vendors generally supply it.
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Post by Sophie Durand on Apr 6, 2016 9:21:53 GMT
We need PDF renditions suitable for inclusion in eCTD
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Post by Donald Palmer on Apr 21, 2016 9:54:46 GMT
A proper Authoring process should not simply provide a review of Content, but should also include a review of the document as it is expected to be submitted. This means a review should be of the PDF that will be submitted and so PDF rendering needs to occur at the Authoring stage, not the Publishing stage. While checking specific PDF specifications might be the Publisher's job (eg. Optimize PDF, BM/Link settings), a final content review should be of the PDF document to ensure images, pagination, working navigation, etc. are correct. To place PDF rendering (a cause of many issues during the overall e-submission process) at the Publishing stage goes against Best Practice and generally results in more post-publishing issues (and corrections that require specialized PDF tools to quickly fix). The Pocket EDMS should support Best Practice.
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Post by Bruce Salkovitz on Apr 26, 2016 13:35:04 GMT
Yes, PDF is required to be submitted to the health authority for majority of documents. However, to require the DMS to be the creator of this file can be cost prohibitive for a small organization. PDF can be created directly by many authoring applications and operating systems, including Windows, MacOS, and MS Word. Centralized PDF rendition creation has its own issues relating to fonts, printer drivers, templates & margin settings. Yes, these can all be addressed, but at a cost. Inclusion of PDF rendering should be an optional requirement to the DMS.
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Adair Turner
New Member
Director of Regulatory and Clinical Operations at arivis
Posts: 2
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Post by Adair Turner on May 17, 2016 23:27:26 GMT
The system should generate PDFs in accordance with eCTD PDF specifications. However, many small companies are just moving to eCTD and consider this as part of the "magical" publishing process.
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Post by Admin on May 30, 2016 7:33:56 GMT
Sounds like an education topic for small companies
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