Watch an Acrobat-SharePoint Integration eSeminar Recording

Many of our customers have either deployed or are interested in deploying Microsoft SharePoint.

Today, my colleague Mark Middleton and did a 1-hour SharePoint eSeminar. Our Partner OmTool also participated; they offer the free Swiftwriter plug-in for Acrobat that provides check-in/out from SharePoint.

Watch Archived SharePoint eSeminar
(Opens in a new window)

If you are not very familiar with SharePoint, it’s hard to describe this popular Microsoft product in a sentence. SharePoint may be used as a web portal, an enterprise search engine, as a collaboration tool, for content management and more.

You probably want to get the most you can from SharePoint in your organization. Since PDFs are one of the most frequently encountered document types in enterprises, Adobe is interested in SharePoint, too.

Read on to view the slides— with narrative sticky notes — from the presentation.

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Capture Discoveries in a PDF Lab Notebook: Part 1

Portfolio IllustrationAn Electronic Lab Notebook (ELN) is digital container for documents and data which is part of the research and development of drugs and medical devices. By replacing paper, you can save money and protect important data and discoveries.

Enterprise class ELN products are available and are good choices for large organizations. For example, CambridgeSoft’s Chemistry E-Notebook offers integration with Adobe Acrobat and enterprise content management systems.

However, what do you do if you are a smaller organization or have a limited budget?

One option to consider is a digitally signed PDF Portfolio, a container structure introduced with Acrobat 9.

A PDF Portfolio is a new concept in Acrobat 9, although it builds upon the PDF Package functionality in Acrobat 8. It’s easiest to think of a PDF Portfolio as a briefcase—or Portfolio— which can hold many types of documents in addition, of course, to PDF.

For example, you could have PDFs, Word Files, Excel documents, instrument data files and more that “live” inside a single PDF document.

PDF Portfolios offer professional-looking Flash-based navigation. Creating a useful interface to your files is simple using the pre-built layouts. In addition, you can “brand” the portfolio with a universal header:


A PDF Portfolio used as a Lab Notebook

The entire PDF Portfolio may be digitally signed on the Portfolio Cover Sheet to protect your important discoveries.

This entry is Part 1 in a series of articles. To start, I’ll present some background information on PDF Portfolios and how they work.

Subsequent articles will cover how to create and customize PDF Portfolios. Read on!

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Where did my Previous/Next View buttons go?

Where did that button go?I was at the ISI eSolutions show recently (great event, by the way) and at lunch I sat next to a regulatory publishing specialist from a large pharma firm.

She had recently migrated from Acrobat 5 to Acrobat 7. In the course of our conversation, I discovered that her department hadn’t received any training on the transition.

Acrobat 7 introduced a new user interface and she couldn’t find the Previous View and Next View buttons.

If you are migrating from Acrobat 5 or 6 to newer version of Acrobat, there’s a good chance things will look different, perhaps a lot different to you.

In this article, I’ll talk about how to get back the Previous View and Next View buttons, and also generally discuss how to customize toolbars to save time and improve productivity.

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Font Embedding Reporting and Automation

I recently wrote about how to embed missing fonts in a PDF.

Font Properties tab from Document Properties

If you have many files to fix—  the norm during regulatory filing preparation— a more automated solution is required.

In this article, you’ll learn how to use Batch Processing to process many PDFs and:

  • Embed fonts where they are missing
  • Move resulting "fixed" files to a new folder
  • Report on any errors and move PDFs which could not be fixed to another folder

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Reembedding Fonts in a PDF

The FDA and other regulatory agencies have specific requirements regarding fonts used in drug applications. Notably, fonts need to be embedded for compliance

Ensuring that fonts are embedded properly is not particularly difficult if documents are in your control. See my blog article on PDF Settings  for some tips.

In a perfect world, all parties which contribute to a regulatory filing would properly embed fonts. Unfortunately, we don’t live in a perfect world . . . there are times when you may need to embed fonts as a post process.

Fortunately, a new feature of Acrobat 9 Pro (and Pro Extended) is the ability to reembed fonts.

Before we get into how to do that, you need to know if the fonts are there or not.

Are the fonts embedded?

To check if fonts are embedded:

  1. Choose File—> Properties
  2. Click on the Fonts tab

Examine the information in the window. If all font entries say "embedded" or "embedded subset" no changes are necessary:

Font is embedded

However, if you see an entry like the one below, you have a problem. In the case below, ArialMT is used in the document, but is not embedded.

Font is not embedded

In the remainder of this article, I’ll discuss how to reembed fonts and also provide background on the term "subset" relative to regulatory guidance.

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Regulatory Compliant PDFs and Beyond

Today, I presented "Regulatory Compliant PDFs and Beyond", an eSeminar, with my colleague Mark Middleton.

If you attended this event, you can download a copy of the slides with notes below.

A9_LS_eSeminar_notes

For those who want to try it, you can also try the experience of downloading this file from my Acrobat.com account.

Using and Deploying SAFE Digital Signatures in Acrobat 8

Instead of collecting pen-and-ink signatures, life science organizations are looking to digital signatures to reduce the time, expense, and data inaccuracies that come from scanning and rekeying information.

SAFE LogoThe SAFE-BioPharma Association has developed a unified business, policy, and technical
model that defines digital signatures for the life science industry.

This cross-organizational standard reduces the time to market and cost of clinical trials by streamlining the way regulatory agencies, pharmaceutical companies, clinical research organizations manage and verify digital signatures.

SAFE has excellent support from many pharmaceutical companies and industry associations who already support the standard.

Adobe Acrobat and Reader 8 have been certified to comply with the SAFE standard.

However, before employing SAFE in Acrobat, some set-up and configuration is necessary.

My colleague Ed Chase has been actively involved in Adobe’s support of SAFE and has written a guide to simplify using and deploying SAFE signatures.

Following, you’ll find the guide which describes how to set up Adobe Acrobat and Adobe Reader to best support the technical and user interface requirements of the SAFE standard.

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What will be in the next version of Acrobat?

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Many of our customers in the Life Science industry have a real interest in planning ahead for new technology purchases.

Since PDF has become the de facto format for regulatory filings, use of Adobe Acrobat is nearly ubiquitous across the pharmaceutical and medical device industry.

It is advantageous to know as much as you can about new software that will arrive in the months ahead. With that knowledge, you can plan your budget, anticipate training needs and investigate how the new product will fit into your existing infrastructure.

What new features will be in the next version of Acrobat?

I can’t tell you here, but you may be able to find out yourself by signing up for Adobe’s Pre-release Program.

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Batch Conversion of Text Files to PDF

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Not long ago, I heard from a large pharmaceutical company working on a new drug submission. As part of the process of testing the new compound, they had written over one thousand Visual Basic programs to process and organize data.

Text File Pic

In communication with FDA staff, they learned that they would be required to submit the computer code for these programs for review by the agency.

As you might guess, the prospect of opening the code for each program individually in a word processor and converting to PDF was not appealing.

Was there a way to automate the process that would also allow control over fonts, layout and the version of PDF needed for submission?

Yes, this is possible using Acrobat 8 Professional.

Read on to learn about Batch Conversion of Text Files to PDF.

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Batch OCR using Acrobat Professional

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Paper— or the digitally scanned equivalent— is still a large component of regulatory filings for many pharmaceutical firms.

Note that the FDA encourages submission of PDF documents created from computer applications instead of scanned PDFs.

The FDA offers this guidance on the CDER site in a PDF document called Portable Document Format Specifications:

Avoid image based PDF files whenever possible. PDF documents created directly from an electronic source such as a word processing file provides many advantages over PDF documents created by scanning paper documents. Scanned documents are more difficult to read and do not allow the reviewer to search or copy and paste text for editing in other documents.

Unfortunately, paper is an unavoidable part of submissions for many firms.

In order to assist agency reviewers, it is a best practice to use Optical Character Recognition (OCR) to create a searchable PDF document from scanned originals.

Background: Making Paper Searchable

Most devices that scan to the PDF format produce an image-only PDF. An image-only PDF contains a picture of a page (scan) in a PDF wrapper— it does not contain searchable text.

Acrobat’s OCR (Optical Character Recognition) feature allows the addition of an invisible layer of searchable text to assist document reviewers:

Acrobat offers OCR via a menu selection

Acrobat Standard can perform OCR on only one document at a time.

Acrobat Professional, however, can create Batch Sequences which offer OCR automation.

In this article, I offer step-by-step instructions to create a batch sequence that allows for the efficient processing of hundreds or thousands of documents.

Note that this article does not cover every aspect of the FDA’s guidance for PDF creation, but I plan to address additional topics in the future.

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