APT, ARCS, Software Release

I’m APT to be a little excited over version 4.0

The holidays came almost two months early for users of ACUTA PDF Tools (APT) as version 4 was released on October 31, 2017. With the new release, APT continues to evolve to work with new guidance, as well as features that improve publishing processes for Bio/Pharma companies using it to assemble their submission-ready documents.

A key feature adapted to regulations is the enhancement of the Redact Wizard. The European Medicine Agency’s Policy 0070, designed to protect both Commercially Confidential Information (CCI) and Individual Patient Data (IPD), has strict requirements for redaction of confidential information. The Redact Wizard has been enhanced to make this simpler, and includes an option for Policy 0070.

One of the primary goals of APT is to add flexibility to the publishing process, something that is painstaking with out-of-the-box Acrobat tools. To that end, a few of the tools have been enhanced:

  • The Bookmark from Link wizard can turn hyperlinked text into bookmarks, so that existing links such as the Table of Contents can, in one step, help comply with agency bookmarking guidance.
  • The Split Wizard now also recognizes standard bookmarks used in Clinical Reports, as defined by the International Council on Harmonisation (ICH) E3 guidance. This helps turn a clinical document that is too large for transmission as a single file into an ICH granular set of PDF files, without worrying about losing existing bookmarks.

Other enhancements include a new Missing Link Wizard which, rather than locating Bigfoot, searches for text in a document that is likely to need linking, such as “See Table” or text pre-marked blue for later hyperlinking.

A bonus you might not have considered is that the extra efficiency helps not just your own offices, but also the ACUTA ARCS teams. When we provide publishing services, their productivity will get the same bump from the new features, reducing the number of hours on a large submission. Contact us for more information on adding APT to your tool belt, upgrading your existing version, or how we can help you manage your submission processes.

 

Photo credit Time Waclawski

Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

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