Debenu PDF Aerialist Pharma and Acrobat versus the FDA PDF guidelines

A while back, I wrote a blog post comparing TRS ToolBox with the dynamic duo of Aerialist Pharma and Acrobat for preparing regulatory submissions. Since then, a lot of you have quite reasonably asked how Aerialist Pharma and Acrobat align with the US FDA regulations themselves, rather than with other products seeking to solve the same problems. That is a fair enough question, I think, and this post is my answer to you.

pharma_768x90_white-blog

There will always be a link to the most recent version of the guidelines here, but as of today, the current guidelines are here (in PDF, of course). Given the importance and stringency of the regulations, this document is surprisingly succinct, clear and simple. In the following sections, I have outlined each of the key areas mentioned, common areas of difficulty, along with the relevant functionality of Aerialist Pharma and Acrobat.

PDF Version

FDA Guidelines: The FDA accepts PDF versions 1.4 to 1.7. Specifically, submitted PDF files must be compatible with Acrobat 8.0, without requiring additional software like plug-ins.

Response: This is almost trivially easy to accomplish in Acrobat. If you haven’t originally created your PDFs using one of the acceptable versions, you can easily convert them using Acrobat’s PDF Optimizer (accessible via Save As > PDF, Optimized, click “Settings”). This conversion process can also be performed on thousands of PDF files at once using Acrobat’s Action Wizard (Tools > Action Wizard).

Security

FDA Guidelines: The guidelines stipulate that you can’t change the security on any PDFs used in your submission. Specifically, that means that you shouldn’t add security to your own documents (i.e., they should not be secured), and don’t modify the settings on the secured forms provided by the FDA (some forms are configured to prevent unauthorized changes).

Response: In general, this won’t require any action on the part of the user, since it essentially requires users to avoid changing security settings. All of this means that you might need to remove security from some of your own PDF files, which can be done in Acrobat (File > Properties, Security tab) if you have the appropriate privileges or password.

Fonts

FDA Guidelines: It’s important that your documents can be displayed consistently across machines. When a font is embedded, every glyph in that font is included in the PDF. That ensures that the PDF contains everything needed to consistently display its text content with appropriate formatting (i.e., the PDF is self-contained). Fonts that are not embedded can result in inconsistent appearance, structure, and can alter apparent meaning in some cases. This is because locally available fonts will be substituted for unembedded fonts unless the same fonts are installed on the viewing machine.

Response: Font embedding can be checked (File > Properties, navigate to Fonts tab) or completed (Tools > Print Production > Preflight) in Acrobat. Acrobat can also be used to process large batches of PDFs via its Action Wizard.

Page Orientation

FDA Guidelines: Page orientation must be such that reviewers don’t need to rotate pages. The most common manifestation of the problem is when landscape pages are not correctly oriented.

Response: This can be done easily for entire documents in Acrobat (Tools > Pages > Rotate). Acrobat allows you to select rotation angle, page range, and original orientation for rotation. This allows you to, for example, rotate all landscape pages counter-clockwise by 90 degrees. Again, the Action Wizard allows for this task to be completed in bulk.

Page Size and Margins

FDA Guidelines: Pages need to fit on a Letter (8.5″ x 11″) standard sheet and have a margin of at least 3/4″ on the left (portrait) or top (landscape) of the page, and at least 3/8″ on other sides. This allows for binding.

Response: If page sizes or margins are not sufficient to meet requirements when PDFs are originally created, these can be altered using the imposition features of Debenu PDF Aerialist Pharma (Tools > Debenu PDF Aerialist Pharma 11 > Imposition).

Source of Electronic Documents

FDA Guidelines: While not a firm requirement, this guideline recommends against the use of scanned documents. If they are used, they must be processed via Optical Character Recognition (OCR) and validated to ensure faithful, searchable text.

Response: Acrobat itself can be used to create PDF files with searchable text from any number of document formats. When working with scanned or other image-based documents, Acrobat’s built-in OCR feature (Tools > Text Recognition) can scan images to produce searchable text within documents. This can also be conducted across many files using Acrobat’s Action Wizard.

Methods for Creating PDF Document and Images

FDA Guidelines: These guidelines stipulate that grayscale and color should be used only when necessary, and that image resolution should be set to 300 dpi, except for photographs, gels and karyotypes, which require 600 dpi.

Response: As long as the original images are of sufficient quality, images can be selectively downsampled using Acrobat’s PDF Optimizer (accessible via Save As > PDF, Optimized > Settings). Individual images can also be downsampled using Acrobat’s Edit Object Tool (Tools > Print Production > Edit Object) and a suitable image editor like Photoshop.

Image Compression to Reduce File Size

FDA Guidelines: The FDA guidelines stipulate lossless compression of images. They mandate Zip (AKA Flate) for color and grayscale images, and CCITT Group 4 for black and white images (e.g., faxes).

Response: These compression techniques are supported by Acrobat. Image compression settings can be configured using Acrobat’s PDF Optimizer (accessible via Save As > PDF, Optimized > Settings).

Optimize for Fast Web View

FDA Guidelines: This option needs to be set to allow for faster opening of PDF files. This allows users or readers to download one page at a time rather than having to wait for the entire file to download before they can view the document.

Response: This option can be enabled in the (hopefully) now-familiar PDF Optimizer (see above). In the PDF Optimizer, this can be enabled by selecting the Clean Up tab and and checking “Optimize the PDF for fast web view”.

Image Color Matching

FDA Guidelines: The guidelines state that CMYK (i.e., print-based) color spaces offer more control than RGB (screen-based) ones, and that the International Color Consortium (ICC) color profile specification should be used when printing.

Response: Color matching is an extremely exacting process. While it’s possible to convert any images into an appropriate color space using Acrobat’s Print Production tools (Tools > Print Production), this will not by itself guarantee fidelity between the final document and the image creator’s intent, as the image was not created in that color space. Nevertheless, converting images into an appropriate color space can at least improve consistency between the submission as sent (i.e., post-conversion) and received (i.e., as it arrives in the reviewer’s inbox).

Despite Acrobat’s powerful capabilities here, conversion should be combined with testing and, if necessary, color correction to ensure the highest level of consistency when this is important to the submission. The better solution, of course, is to create the images using the same color space as that used in the submission version, precluding the need for conversion.

Thumbnails

FDA Guidelines and Response: These are not required for PDF submissions, or indeed any PDFs, as thumbnails can be automatically generated by viewing software.

Hypertext Linking and Bookmarks in Text and Table of Contents

FDA Guidelines: The guidelines endorse the liberal use of hyperlinks throughout PDF files to facilitate navigation within and between documents. When they are used, hyperlinks should be designated by thin rectangles or blue text. To minimize confusion, a consistent design is recommended. It is also recommended that relative rather than absolute paths are used to ensure that inter-document links are not broken when files are copied to a new location.

For documents containing tables of contents (TOCs), the guidelines state that both bookmarks and links should be created for each entry. The use of invisible rectangles and blue text is recommended to signal hyperlinks without obscuring important text. Bookmarks must be hierarchical, organized in precisely the same way as TOC entries (up to four levels deep). Finally, all links and bookmarks should be set to “Inherit Zoom” to ensure a consistent reading experience.

Response: Using Acrobat, users can manually create, edit or delete bookmarks and links (Tools > Content Editing). Acrobat can also be used to remove all links from a PDF (Tools > Document Processing > Remove All Links). Debenu PDF Aerialist Pharma adds a range of powerful options here, many of which can be used to process large batches of documents via their compatibility with Acrobat’s Action Wizard. These are set out in more detail, below.

Links

First of all, Aerialist Pharma can be used to dynamically create links based on keywords (Tools > Debenu PDF Aerialist Pharma 11 > Links > Create Keyword Links) or page numbers (Tools > Debenu PDF Aerialist Pharma 11 > Links > Create Page Links), which is ideal for adding links to an existing TOC. Links can also be imported or exported between PDFs (Tools > Debenu PDF Aerialist Pharma 11 > Links > Export/Import Links).

Aerialist Pharma can also be used to modify link properties throughout a given document (Tools > Debenu PDF Aerialist Pharma 11 > Links > Set Link(s) Properties), which can be used to modify the appearance and behavior (e.g., setting zoom level) of links to conform with FDA guidelines.

Additionally, Aerialist Pharma can selectively delete all links or just dead ones (Tools > Debenu PDF Aerialist Pharma 11 > Links > Delete Links), and features a link auditor (Tools > Debenu PDF Aerialist Pharma 11 > Links > Audit Links) that can be used to find and fix broken links and bookmarks. Aerialist Pharma’s functionality also allows users to generate reports about problem links, bookmarks, external dependencies, or simply count links (Tools > Debenu PDF Aerialist Pharma 11 > Links > Reports).

Bookmarks

Meanwhile, Aerialist Pharma also allows the dynamic creation of bookmarks based on existing TOCs or folder structure or folder structure (Tools > Debenu PDF Aerialist Pharma 11 > Bookmarks > Add Bookmarks, click Import), text formatting such as headings (Tools > Debenu PDF Aerialist Pharma 11 > Bookmarks > Build Bookmarks). Like links, bookmarks can also be imported or exported between PDFs (Tools > Debenu PDF Aerialist Pharma 11 > Bookmarks > Add Bookmarks, click Import or Export) or settings files (Tools > Debenu PDF Aerialist Pharma 11 > Bookmarks > Build Bookmarks, click Import). Aerialist Pharma can also bind separate documents, adding a shared bookmark structure to all selected documents (Tools > Debenu PDF Aerialist Pharma 11 > Bookmarks > Bind Documents).

Bookmarks can be searched (Tools > Debenu PDF Aerialist Pharma 11 > Bookmarks > Find Bookmarks), sorted (Tools > Debenu PDF Aerialist Pharma 11 > Bookmarks > Sort Bookmarks), or deleted (Tools > Debenu PDF Aerialist Pharma 11 > Bookmarks > Delete Bookmarks), and their properties can be edited in bulk using Aerialist Pharma (Tools > Debenu PDF Aerialist Pharma 11 > Bookmarks > Edit All Properties). They also benefit from the reporting, auditing and fixing options noted above for links.

Tables of Contents

Aerialist Pharma allows for the dynamic creation of document or master (i.e., inter-document) tables of contents from bookmarks, headings/text formatting, file and folder structure (Tools > Debenu PDF Aerialist Pharma 11 > Table of Contents).

Initial View Settings

FDA Guidelines: PDFs should be set to show “Bookmarks Panel and Page” unless there are no bookmarks, in which case, they should be set to “Page Only”. Default settings should be used for Page Layout and Magnification.

Response: These settings are easily accessible in Acrobat (File > Properties in the Initial View tab), and can be set for large batches of PDF files using Acrobat’s handy Action Wizard.

Page Numbering

FDA Guidelines: Page numbers should match between document and file (i.e., the initial page should be page 1) unless the submission has been split into multiple files. In this case, page numbering should match intended logical reading order without duplication. For example, if sections of the submission are separated into different files and Section 1 ends at page 10, Section 2 should commence on page 11.

Response: This can be accomplished, with different sets of options, using either Acrobat (Tools > Pages > Header & Footer) or Aerialist Pharma (Tools > Debenu PDF Aerialist Pharma 11 > Stamps).

Naming PDF Files

FDA Guidelines: These guidelines stipulate that PDF file names use lower case letters and avoid special characters aside from hyphens or underscores.

Response: While no separate application is needed to name or rename PDF files, Acrobat’s Action Wizard does allow users to add prefixes and suffixes to output file names in bulk as they are processed.

Special Considerations for Promotional Material

FDA Guidelines: These guidelines relate to the submission of promotional material. As such, they require high resolution (minimum 600 dpi), consistent color display (see Image Color Matching, above), and should be submitted according to their actual size.

Response: Again, Acrobat allows for image downsampling and color space conversion, but as noted earlier, this may not be advisable without subsequent testing. Acrobat and PDF support very large page sizes, so the requirement for size fidelity is unlikely to run up against hard size limits.

Other Concerns

Long-Term Archiving of Documents

While it is not explicitly listed in the FDA guidelines for PDF, it can also be important to archive submissions. In the case of PDF, there is are several formal standards for this, known variously as PDF/A-1 (ISO 19005-1:2005), PDF/A-2 (ISO 19005-2:2011) and PDF/A-3 (ISO 19005-3:2012).

Acrobat supports these standards admirably. Acrobat’s Preflight tools support compliance-checking and conversion to these standards via pre-configured profiles (Tools > Print Production > Preflight, expand “PDF/A compliance”).

Presentation Fidelity

It is crucial that PDF submissions are identical in appearance to their paper equivalents. This consistency ensures that no information is lost in translation. This particular point speaks most to the choice of format for submissions. PDF’s page fidelity, cross-platform compatibility and (if appropriately prepared) self-contained nature make it an ideal transfer format.

Standardization of Document Processes

Human error is a random variable that can confound even quite sophisticated processes. As a rule, standardizing procedures and reducing manual handling minimize the risk of error. The ability of Aerialist Pharma and Acrobat to automate time- and labor-intensive processes within and across documents significantly reduce manual handling and hence, the risk of human error.

Final Thoughts

In concluding, I would like to reiterate that you can meet all of your PDF compliance requirements for US FDA submissions by using a combination of Acrobat and Aerialist Pharma. Some of the FDA’s guidelines, frankly, are best met at the content creation stage (color matching and correction come to mind). Even then, Acrobat and Aerialist Pharma can help with meeting one’s compliance burden with sub-optimal source content. Used together, Acrobat and Aerialist Pharma can drastically reduce manual handling time, improve consistency and minimize the risk of human error. As a result, your submissions will be more likely to be note-perfect when initially sent. This in turn reduces the significant costs, administration and lost opportunities associated with re-submission. Given that it can form such an integral part of the workflow, it is work noting that there is a fully-functional trial version of Debenu PDF Aerialist Pharma available. For that matter, there is also a free trial of Acrobat available from Adobe’s website. Why not try them out? We’re happy to help you get set up and answer any questions you might have.

Posted in Articles, Debenu PDF Aerialist, Debenu PDF Aerialist Pharma | Leave a comment

Thanks for your thoughtful responses so far!

mainbanner_hp

First of all, thanks to those of you who have provided the flurry of responses to our survey about Debenu’s pending PDF SDK for developing Android and iOS apps. If you haven’t done so yet (and are interested in shaping our mobile PDF SDK), please do so here.

One thing has come through pretty clearly in the responses to date. It seems like a lot of you really want to help. We were expecting the responses about how it’s important/urgent/a life-or-death matter that you can find something to help you solve your current development problem. As developers ourselves — not to mention the people behind a commercial SDK — we understand it and will do our best to help you out.

What we weren’t expecting was the show of support. Quite a few of you took advantage of the section set aside for write-in responses and offered us the benefit of your sometimes extensive experience in the mobile development space. Thank you for your unexpected but much appreciated outpouring of wisdom!

While we haven’t confirmed a final set of functionality for our mobile SDK, there are definitely a few strong themes that are starting to emerge. We definitely still want to hear from anyone who is willing to put in their two cents. Just in case you missed it the first time, Debenu Labs is now available for your testing and feedback.

Posted in Articles, Debenu Quick PDF Library | Tagged | Leave a comment

Help us make the best mobile PDF SDK

We’ve been putting the word out, but just in case you didn’t already know, we’re taking Debenu Quick PDF Library mobile for Android and iOS devices. It will happen soon, too — as in, later-this-year-soon. We’re excited. There aren’t a lot of mobile PDF SDKs around, but there are a few out there. We think we can do it better, though, because we have a secret weapon: you, our developer community.

While we will build the library, you will be the ones who (we hope) will want to build with it. That being the case, we want to start an ongoing dialogue with you about how to make and keep this the best PDF SDK for mobile out there.

Let’s start with the basics. What sorts of apps do you want to build? Some of the available libraries are very focused on PDF viewing. Some, like Adobe Reader Mobile SDK are really only designed for building consumer-level viewing apps. Most seem to support digital rights management (DRM), either natively or by allowing apps to open PDF files from memory, which allows integration with a separately bought or built document security infrastructure. Others, like Foxit Embedded PDF SDK and PDFTron’s PDFNet Mobile PDF SDK offer broader functionality, with additional features available via add-on modules.

We really want to know what you think, and we want to use your feedback to drive our development roadmap. Ultimately, we want you, our (potential) developers to have a strong voice in shaping the final product. The best way for you give us your two cents is to complete our survey, but please also comment on this post if you have anything else to say. Either way, we’d love to hear from you!

Posted in Articles, Debenu Quick PDF Library | Tagged | Leave a comment

The Female Technologist: The Upside of Being a Woman in Tech

We often hear people talking about social progress — or the lack thereof — in the technology sector. It wasn’t so very long ago that Twitter was abuzz with tweets using the #1reasonwhy hashtag to aggregate the many reasons, big and small, that there weren’t more women working in the gaming industry. Ubisoft’s Jade Raymond was on the receiving end of some rather nasty online harassment, essentially, it has been argued, for being female, attractive, and good enough at her job to win awards during her rise to international prominence. In reference to their rarity, Raymond has described women in the gaming industry as being “like unicorns”, but she also says that is changing. Raymond now heads Ubisoft Toronto, where 20% of her developers and half of her “senior leaders” are female. Independently, the flurry of activity around the #1reasonwhy hashtag inspired #1ReasonMentor, a hashtag that emerged to offer “advice and help to anyone struggling to overcome sexism in the industry.”

You won’t be surprised to hear that this phenomenon — that is, the relative scarcity of women — is broader than just the gaming industry. I have been the only woman at tech meet-ups more times than I can remember. That hasn’t been a bad thing, though. I recently discovered by accident that my gender was actually opening some doors for me. The rest of the Debenu executive team and I are active members of the local tech-focused entrepreneurial community. We regularly attend networking events in our area. People who attend these gatherings really run the gamut, from those who have just come up with their first big business idea to grizzled veterans who are years into running successful businesses.

I remember debriefing with Karl and Rowan (my male fellow Debenu execs) after one of these gatherings recently. I felt that it had been a great success. I had spoken to a lot of fellow entrepreneurs, made small talk, chatted about our families, and of course, talked a little business. Moreover, the whole night had felt rather relaxed and pleasant. I was quite surprised to hear that Karl and Rowan had both had a completely different experience. They said that it had felt like they had been locked in a fierce struggle for status all night, with the other guests constantly seeking to compare growth, turnover, profit and staffing figures. At first, it was hard to believe that we had been at the same event.

Of course, in hindsight, it makes more sense. When you get that many driven, ambitious people in one place there is bound to be a current of competition (healthy or otherwise) running through the room. Being the sole woman in gathering of tech entrepreneurs, I think I forced everyone to go off-book. Instead of going through the whole ritual of comparing balance-sheets, we were able to just cut straight to the actual point of the evening and start networking.

I realize that being a woman working in a senior role for a technology company makes me unusual. Maybe that won’t always be true — Debenu’s head programmer is only the most senior female member of our development team (as in, she is decidedly not our only female developer). For now, I’ve found that being a woman can be a significant professional advantage in this male-dominated industry. Things might be gradually changing with respect to the gender balance in the tech industry, but for today, I’m still a unicorn, and I’m more than OK with that.

Posted in Articles | Tagged | Leave a comment

Debenu PDF Viewer SDK 10.15 Released

The final version of Debenu PDF Viewer SDK 10.15.0.3 has been released and is ready for download from our product updates page.

This new version is full of new functions, enhancements and bug fixes and we recommend that all customers upgrade to it to take advantage of the improvements. Visit the product updates page to download this new version and see a full list of the changes.

Download 10.15 from our Product Updates page

Version 10.15 Highlights

  • Now supports 32-bit and 64-bit applications
  • Improved document loading times
  • Improved large zoom rendering performance
  • Max zoom increased to 1600%

Upgrading

This is a free upgrade for all customers who have purchased a license to a previous version of Debenu PDF Viewer SDK.

Feedback

As always we’d love to hear your thoughts on the new version of Debenu Quick PDF Library. If you have any questions, comments or general feedback, please let us know.

Posted in Debenu PDF Viewer SDK, Debenu Quick PDF Library, News, Releases | Leave a comment

Debenu Quick PDF Library 10.15 Released

The final version of Debenu Quick PDF Library 10.15 has been released and is ready for download from our product updates page.

This new version is full of new functions, enhancements and bug fixes and we recommend that all customers upgrade to it to take advantage of the improvements. Visit the product updates page to download this new version and see a full list of the changes.

Download 10.15 from our Product Updates page

Version 10.15 Highlights

  • Delphi XE6 compatible
  • 4 new functions, 26 bug fixes and 3 enhancements

Upgrading

Debenu Quick PDF Library 10 is a major new version of the product which means that the upgrade process is different from the minor version upgrade process, namely, upgrades are not free unless you meet certain requirements.

Free upgrades

Customers who purchased version 9 of Debenu Quick PDF Library on or after the 24th of August, 2013 (within 60 days of version 10’s release) or who own an active Premium Upgrade Protection subscription are eligible for free upgrades from version 9 to version 10.

Contact our sales team if you fall into this category and we’ll help you out.

Purchase an upgrade

An upgrade from version 9 or earlier versions to version 10 can be purchased at a discount (starting price is $269.00) through our online store. Users can upgrade their Single Developer, Multiple Developer or Source Code licenses to version 10. It’s also possible to purchase Premium Upgrade Protection with your upgrade purchase.

For example, if you own a Single Developer License + Standard Upgrade Protection for version 9 of Debenu Quick PDF Library then you will need to purchase the Single Developer Upgrade License + Standard Upgrade Protection (9.x to 10.x) product in order to upgrade to version 10 — though you can choose to buy the Premium Upgrade Protection version of that product if you prefer.

Feedback

As always we’d love to hear your thoughts on the new version of Debenu Quick PDF Library. If you have any questions, comments or general feedback, please let us know.

Posted in Debenu Quick PDF Library, News, Releases | Leave a comment

Debenu Quick PDF Library: Coming soon to Android and iOS

We’re all very excited about this here at Debenu. The light is well and truly green, and the team is hard at work making Debenu Quick PDF Library for Android and iOS a reality, to be officially rolled out with the next major release later this year. We’ve been planning this for quite a while, but the pieces have finally fallen into place. We now know how and, more importantly, when we’re going to be able to provide this much-requested functionality to you, our developer community.

Smartphones, tablets and other mobile devices really to seem to be the way of the future. Part of it is the growing power of portable computing devices. Today’s smartphones have significantly more power than the combined might of all the computers used to co-ordinate the moon missions. The moon missions, people! Actually, according to ComputerWeekly.com, even a humble pocket calculator is more powerful than were those impressive relics of modern history. That really just underscores the point, though.

This exponential growth in power, along with the spread of fast cellular and wifi data networks, has led to a corresponding growth in the utility of mobile computing. Android, iOS and other mobile devices are now in integral part of our lives and the way we work. For myself, I am inseparable from my Android smartphone, a Samsung Note 3. I’m constantly working on it, writing presentations, emails, speaking to customers via LiveChat and exchanging files when necessary with Google Drive. If you’ve ever heard from me, there’s a good chance it was courtesy of my large-screened, mega-work tool (that’s what I call my smartphone).

By the end of the year, you’ll be able to leverage the robust and flexible functionality of Debenu Quick PDF Library for use by people like me who live and work on our mobile devices. If you’re eager for a sneak peek, pre-release versions will be available on Debenu Labs for testing and comment before you know it. As usual, we’ll work to integrate your feedback into our development plan and iron out any issues you happen to find. We’d love to hear from you.

Posted in Debenu Quick PDF Library | Leave a comment

The patience required for the internet

Some think that completing their product is the end of the road, and that gold bullion will pour down from the sky and into their wide-open pockets. Let’s just say that, in my experience with start-ups, this is an optimistic misconception. For most, this so-called “conclusion” is nothing but the start of a one-to-two-year marathon before they can expect to see even an occasional light shower of silver or copper.

To put this another way, there’s a lot of hard work between “code complete” and “sale complete”. In the first software company I founded back in *ahem* 1997, we worked all hours to get our first product to market in time, and we did it. We were bleary-eyed and overtired, but man were we psyched. We hit the button and … heard the sound of crickets. Someone coughed in the distance. I swear I saw some tumble-weeds roll past. To one degree or another, that went on for almost two years. Sales figures for that period were a big old goose egg. When it finally came, we framed the check that paid for our first sale. Of course, the story has a happy ending, because if things hadn’t picked up from there, we probably wouldn’t be here today.

There are no two ways about it: building a business always takes energy, resources and a lot of patience. If you are primarily or entirely online, then patience is even more important. Back in 1997, the internet was not as well indexed, featured fewer users and less content, but the challenge was essentially the same: get seen by as many potential customers as possible. Online, everything is about search. People find what they are looking for. You can have the best product and the most beautiful, elegant website known to humankind, but until Google loves you, no-one will ever see it. If no-one sees it, no-one buys it, it’s as simple as that.

Over time, search engines will start to pick you up, you’ll gradually gather press mentions and links from other sites. But it all takes time and patience. It’s ironic, really. The internet is a medium where more information moves and changes faster than at any time in history, but shifts in online buyer behaviour (at least for business software) still seem to happen so slowly.

My advice for the budding online software entrepreneur? Start with a bright idea, plan well, build something solid and then hunker down for the long haul. Trust me, it’s worth it.

Posted in Articles | Leave a comment

Questions Answered: Submit a Question AND Help Grow the Debenu Knowledge Base

Just to be clear, we’re not asking anyone to write KB articles here. Just tell us about your PDF development problems and challenges — think of us as a PDF therapist. Picture the scene:

A frustrated YOU lies on a plush, leather couch, looking up at the ceiling. DR DEBENU sits on a nearby chair, attentively balancing a notebook on crossed legs.

DR. DEBENU: So, tell me a bit about what’s brought you here today.

YOU: I, well, I guess it all started when I needed to dynamically generate PDF invoices…

DR DEBENU: What a coincidence! I was able to help someone just last week with the same issue! In fact, I thought it might be helpful, and wrote an article about it for the Debenu Knowledge Base.

YOU: Wow, I feel better now! Thanks, Dr Debenu!

See? Easy. All you need to do is leave a comment that outlines your PDF-related query and which Debenu product you think might be best suited to the task. Not only will you get support for your immediate issue, you might inspire a Knowledge Base article. You’d be able to send it to other users to save time with explanations, and the article could help future users.

Posted in Articles | Leave a comment

Why buy Aerialist Pharma over TRS ToolBox (formerly ISIToolBox)?

I realize that it’s often considered a marketing no-no to mention a competitor by name, but the title of this post is a good question that deserves a proper answer. Since we have received a lot of queries about this, I wanted to talk about the comparison and, hopefully, clear up some misconceptions.

ISIToolBox has been around for a long time. I first heard about it more than a decade ago when I was working in pharma myself and consulting to companies working on establishing good submissions practices. Sure, you needed to buy Acrobat first, since ToolBox worked as a plug-in, but what a plug-in it was! Some of the features were so strikingly distinctive and useful. As the years marched on, even more functionality was added, which saw the feature count for ToolBox grow from 40-plus in 2003 to 50-plus today.

In essence, it seems that those responsible for ToolBox (first ISI and now CSC) have taken an incremental approach to building the product. It is this approach that is responsible for the gradually increasing list of features. We tackled the development of Debenu PDF Aerialist, and in particular, the Pharma edition, rather differently. From the outset, we wanted it to seamlessly complement Acrobat’s functionality to deliver an integrated solution for those preparing documents for eCTD or NeeS submissions, e-filing or other purposes. That meant that we needed to start by carefully studying Acrobat’s interface and features to avoid redundancy. Acknowledging that Acrobat was delivering a key subset of the required functionality, we also started at a lower price-point than ToolBox. Finally, since we thought that the best test of whether a solution would fit a company’s workflow was to try it, we have always made sure to offer a fully-functional, free trial of Aerialist Pharma.

The different results of these two approaches is most apparent when using the latest versions of Acrobat. Adobe has been far from complacent in the last decade: ultimately, many of the third-party features that were so impressive in 2003 have since been built in to Acrobat. In other words, you can accomplish quite a lot without resorting to any plug-ins. The best way to illustrate this feature duplication is probably to work through the key features outlined on the TRS ToolBox product pages. Below, I’ll run through those key features, specifying how they can be addressed using the combination of Acrobat XI and Debenu PDF Aerialist Pharma.

  • Create bookmarks and hyperlinks. Aerialist Pharma can create bookmarks or links based on keywords, headings, fonts, tables of contents, page references, PDFs, settings files, or folder locations.
  • Manage, validate and audit links and bookmarks. In Aerialist, links and bookmarks can be configured, viewed, audited and validated in bulk. This functionality also allows users to repair bookmarks and links.
  • Access a palette of publishing tools. Aerialist Pharma features rich functionality for splitting, merging, stamping, and watermarking PDFs. Aerialist Pharma can split by page range, bookmarks, or page marks. Meanwhile, merging can be conducted either manually or according to a control file. Users can also add page numbers, letterheads, headers and footers, logos, or a range of dynamic stamps (including Bates numbers).
  • Redact content. Acrobat features strong support for redacting or censoring sensitive content. Users can remove the desired content manually or automatically via keyword, key-phrase or pattern-recognition (i.e., credit card details, phone numbers, social security numbers, email addresses or dates). Acrobat can also sanitize a document by removing sensitive information that may not be visible, including metadata, hidden or obscured content, or stored form data.
  • Enhance the quality of PDF files. Acrobat features sophisticated optical character recognition (OCR) functionality, can enhance scanned images, and reduce PDF file size for easy transmission.
  • Easily extract text and images from PDF files. Acrobat natively supports the extraction of PDF content by either manually selecting text and/or images. Acrobat can also convert entire PDFs as into a range of editable formats.
  • Instantly prepare hundreds or thousands of files. Using Acrobat’s Action Wizard, selected files or whole folders of files can be prepared in large batches. Users can create Actions, each of which consists of a series of ordered steps using Aerialist Pharma or Acrobat features. Actions can be set to process thousands of files at a time and are saved for future use.
  • Leverage the flexibility of named destinations. Aerialist Pharma users can easily create, manage or modify bookmarks and links in bulk. Further, intelligent splitting and merging functionality is set by default to automatically preserve or update links and bookmarks regardless of re-pagination.
  • Prepare and validate electronic Common Technical Document (eCTD) submission and non-eCTD electronic submission (NeeS). Aerialist Pharma can create a NeeS table of contents, and can audit links or bookmarks in submissions regardless of language.

So, with all of that in mind, I think you are left with four key reasons for choosing Aerialist:

  1. Price. First and foremost, Aerialist Pharma wins the price contest, hands-down. TRS ToolBox starts at $750 for the Standard or Legal editions, and $3,950 for the Professional or Pharma editions. By contrast, Debenu PDF Aerialist Pharma is a steal at $495.
  2. Lack of redundancy. Both Aerialist Pharma and ToolBox are Acrobat plug-ins, but while Aerialist Pharma has been crafted to work elegantly with Acrobat, ToolBox still includes obsolete features that are now natively supported by Acrobat.
  3. Free trial. While both vendors offer pre-sales support, there is only a free, fully-featured trial version available for Aerialist. Given the important role of the product chosen, this allows potential customers to properly stress-test the product under real-world conditions.
  4. Feature parity. While they present and implement their functionality in different ways, both product offerings offer the key features needed to facilitate document preparation in the legal, pharma and academic sectors. While this isn’t a reason to choose Aerialist, per se, it is a reason to consider it on an equal footing with ToolBox.

That’s all from me for now, but please do keep those good questions coming! If you would like to try Debenu PDF Aerialist Pharma there is a 14 day free trial

Try it free.

 

Posted in Articles, Debenu PDF Aerialist, Debenu PDF Aerialist Pharma | Leave a comment