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Blog

6 good reasons why leading Life Sciences companies are rethinking their Document Rendering Solution

  • March 3, 2019

Related Topics

We have been converting divergent documents into a unified format such as PDF for many years now.

In knowledge-driven industries such as Life Sciences in particular, the need for standardization is highly motivated by the regulators. The introduction of the electronic Common Technical Document (eCTD) has accelerated the move from paper to electronic formats. And the International Conference on Harmonization (ICH) has further solidified this drive in its recent implementation guides for Regulated Product Submissions (RPS).

Most pharma and biotech companies have had solutions in place for several years already. Many companies are reviewing their document management strategy. Some have already started to review their rendering strategy as well.

We have asked these leading companies what made them rethink their strategy and question the solution set that was in place.

What challenges made them rethink their existing solution and tool set?

  1. Their current rendering process is too slow, and a resource hog. This results in higher costs for infrastructure. On top of this, the infrastructure dedicated to rendering remains largely unused due to variations in load.
  2. The process does not scale, and has a hard time dealing with peak loads. The infrastructure foreseen is therefore over-scaled, again leading to additional costs. Rendering farms are often over-dimensioned by a factor of 3, purely in order to deal with these peak loads.
  3. The rendering process is halted due to memory leaks, which require a restart of the machine. On top of that, ‘Are you sure?’ pop-ups interrupt the process, leading to time costs due to the need for human intervention.
  4. Every user and every conversion server must have Microsoft Office, Adobe or other licenses which has a big impact on licensing costs.
  5. The number of input formats per tool is limited. That’s why multiple tools are being used throughout the organization to deal with an ever-growing number of file formats, in particular during this time of numerous company mergers and acquisitions. This leads to inconsistent output.
  6. The desired output is not configurable. In order to ensure ICH compliance, manual interventions are needed, post conversion, which increases the risk of human error.

Often, the reason for these shortcomings is purely architectural. The tools that Life Sciences companies are using were designed years ago, with a particular goal in mind.

But time has moved on, the world has evolved, and today there are alternatives for creating compliant, submission ready PDF. It doesn’t have to be manual or complex anymore.

As you might have guessed, we do things differently. If you are interested how, definitely have a look at the video below: 

 

About DocShifter

Speed, quality, scalability, and configurability are reasons why Life Sciences organizations choose DocShifter to generate technically compliant, submission-ready PDF. High volume, high-quality document conversion, on-premises, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs.

 

 

We have been converting divergent documents into a unified format such as PDF for many years now.

In knowledge-driven industries such as Life Sciences in particular, the need for standardization is highly motivated by the regulators. The introduction of the electronic Common Technical Document (eCTD) has accelerated the move from paper to electronic formats. And the International Conference on Harmonization (ICH) has further solidified this drive in its recent implementation guides for Regulated Product Submissions (RPS).

Most pharma and biotech companies have had solutions in place for several years already. Many companies are reviewing their document management strategy. Some have already started to review their rendering strategy as well.

We have asked these leading companies what made them rethink their strategy and question the solution set that was in place.

What challenges made them rethink their existing solution and tool set?

  1. Their current rendering process is too slow, and a resource hog. This results in higher costs for infrastructure. On top of this, the infrastructure dedicated to rendering remains largely unused due to variations in load.
  2. The process does not scale, and has a hard time dealing with peak loads. The infrastructure foreseen is therefore over-scaled, again leading to additional costs. Rendering farms are often over-dimensioned by a factor of 3, purely in order to deal with these peak loads.
  3. The rendering process is halted due to memory leaks, which require a restart of the machine. On top of that, ‘Are you sure?’ pop-ups interrupt the process, leading to time costs due to the need for human intervention.
  4. Every user and every conversion server must have Microsoft Office, Adobe or other licenses which has a big impact on licensing costs.
  5. The number of input formats per tool is limited. That’s why multiple tools are being used throughout the organization to deal with an ever-growing number of file formats, in particular during this time of numerous company mergers and acquisitions. This leads to inconsistent output.
  6. The desired output is not configurable. In order to ensure ICH compliance, manual interventions are needed, post conversion, which increases the risk of human error.

Often, the reason for these shortcomings is purely architectural. The tools that Life Sciences companies are using were designed years ago, with a particular goal in mind.

But time has moved on, the world has evolved, and today there are alternatives for creating compliant, submission ready PDF. It doesn't have to be manual or complex anymore.

As you might have guessed, we do things differently. If you are interested how, definitely have a look at the video below: 

 

About DocShifter

Speed, quality, scalability, and configurability are reasons why Life Sciences organizations choose DocShifter to generate technically compliant, submission-ready PDF. High volume, high-quality document conversion, on-premises, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs.

 

 

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Compliant, fast, automated and scalable
file format conversion for the regulated enterprise.

See what our beloved customers have to say about us:

"DocShifter is converting 36.000 documents per day, coming from all over our company (and external). We have no control over what is coming in. And still the failure rate is below 1%.

And what really sets it apart from what we were doing before, DocShifter tells us what went wrong, so we can act upon the documents that did not convert".
Operations Manager Large European Bank
"DocShifter will save us over 750 hours of manual work per year. And we expect the time savings to increase as we continue to expand our use of DocShifter.

This is significant for our clients who need the eCTD sequences to be published quickly, accurately and efficiently. "
Jennie MayDirector, Regulatory Operations - PharmaLex
"Very powerful tool for document conversion and generation. The DocShifter software goes further than our current needs, and from my point of view quite unique in the industry. Quick adaption due to user-friendly workflow creation functionalities. Possibility to create workflows in a user-friendly (non-IT) way. Possibilities for seamlessly integrations into existing solutions."
Kris V.ITS Business Partner, Clinical Development
"We are using DocShifter in conjunction with Documentum software. The rendition performance that is observed so far is more than 4000 documents per hour (on 1 single instance). The output provided is fully compliant to health authority specifications (FDA, EMA, PMDA, HC, SwissHealth, etc.) and is configurable for different countries. A true enterprise document conversion solution.”
Piyush J. Solution Manager
"We use DocShifter to prepare compliant, submission-ready PDF renditions for all regulatory content.

The product is reliable, extremely fast and produces output that is compliant with multiple Health Authorities."
Large US biotechnology companyRegulatory Information Systems Manager
"We implemented DocShifter into production and have converted over 35.000 documents. Our failure rate has dropped from over 10% to well under 0.1%. We have seen an astronomical improvement in our document conversion processes thanks to how easy DocShifter was to implement and to use. In the course of 12 months, we are going to convert more than 100.000 documents with DocShifter. Fantastic document conversion solution!”
Chris B. IT System Administrator - PeopleScout Technology
"We have documentation in different languages, but when converting everything to PDF for submissions, things got complicated really fast. Our rendition engine couldn't cope with all those fonts, and we lost a lot of time fixing problems that weren't supposed to be there in the first place. We decided to make a switch to DocShifter. Scalability during our peak times, ability to deal with multiple fonts, automation (conversion of source documents to simultaneous submission-ready PDFs for multiple health authorities) and performance. These are just some of the things that make DocShifter such a powerful rendering engine."
Jade O. Document Management Professional
"We selected DocShifter for the incredible ease-of-use, the simple configuration and implementation, the high-quality ICH compliant output, and the huge number of formats supported. Performance is excellent, and we reduced the number of rendition servers by a factor of 3. All of this, plus the company’s responsiveness made it an easy choice."
Regulatory Operations & Global Submissions SpecialistLarge pharmaceutical company
"DocShifter powers the document conversion solution in Generis’ new CARA cloud offering. “We already support many joint customers who have advanced document conversion requirements met by the integration of DocShifter with CARA. We are now happy to be able to offer this on a pre-built package with New CARA on our cloud for such customers.”
James KelleherCEO - Generis
"As we are in the middle of a paradigm shift from analogue to digital in Japan, I have been looking for the right solution to support this for many years. In DocShifter we have found a company with solutions that have been selected by organizations of all sizes because of their responsiveness, cost-effectiveness, class-leading performance and unique capabilities that rise above the competition.”
Kosuke OmodaPresident - eSA Japan
"One of the things we love about DocShifter is the graphic interface to configure file transformation flows. The user interface is very simple to use and rare to find within other similar document conversion products. Wide selection of connectors to different solutions (EIM & DMS systems) make DocShifter a great choice for our company as well. We also are very happy with the customer support we receive: extremely friendly and prompt.”
Nikita L.Information Management Consultant
"With DocShifter, we are seeing better performance with even less resources, compared to our previous solution. The deployment is very easy, and the utilization of hardware/software resources are extremely efficient. Thanks to DocShifter's architecture and not needing Office applications, we were able to save a lot of money and resources by the switch.”
Istvan V.Solution Architect
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15 years of experience in automating, simplifying and speeding up document conversion.
For all regulated industries. 

 

 

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DocShifter document conversion solution is rated 5 starts by our customers on Gartner's Capterra platform.

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