A Case Study in Regulatory Operations: Digital Transformation of the Workforce
If you work in Regulatory Operations, you are probably knee-deep in transformation. Whether you are upgrading your entire RIM system (or parts of it), or migrating to cloud-based solutions, testing and implementing automation of repetitive and manual tasks, and preparing for IDMP, CTR and data submissions in general, it probably feels like change is everywhere […]
What You Should Know About Document Transformation Services
Mass digital document transformation is one of those things that your business might only need once or twice. System migration, archiving or regulatory requirements are often driving this requirement. And when it has to be done, it can be a big headache. You just want it taken care of with as little hassle as possible. […]
What is Document Rendering, and what can it mean for your business?
Document rendering is viewed by many as simple document-to-PDF conversion. Nothing more. However, did you know that document rendering can actually do a lot more than just converting from one format to PDF? We will explain what additional functionality document rendering can bring to your business. Many elements can be added to PDF documents to […]
What is the PDF/A format, and how to use the PDF/A format for your Digital Archive
Many of us in business and IT set up and maintain digital archives. Banks, insurance, and healthcare or other regulated industries carry a heavy backlog of archival information going back months or years for thousands of clients. The Bank of England has a public archive of their work, citing more than 96,000 records just on […]
Pharma time-to-market reduced thanks to more efficient submission document publishing services
PharmaLex, a leading provider of specialized services for the pharmaceutical, biotech and medical device industries, chose DocShifter to simplify and accelerate the generation of compliant, submission-ready PDF documents for their 1000’s of clients worldwide. PharmaLex’s services include document pre-publishing and regulatory submission publishing, therefore managing large numbers of documents in different formats and differing […]
How to design or implement an enterprise file conversion platform?
What is enterprise file conversion? What does it mean? Enterprises or businesses deal with a lot of documents, in multiple formats. Word, Excel, PowerPoint, PDF, PDF/A, scanned images, JPEG, TIFF, audio and video files, XML, HTML, e-mail files and many more. All these files need to be converted for many reasons: standardization, digital archiving, customer […]
How to reduce regulatory content creation issues? 4 tips.
Life Sciences organisations are required to create huge quantities of documentation to support the marketing of their products around the world. Industry standards have been put in place to ensure that Global Health Authorities receive content in a manner that simplifies the review and approval process of new medicines or devices. These guidelines do provide […]
Free checklist for PDF format specifications for FDA submissions
Pharmaceutical and biotechnology companies spend a lot of effort in the R&D process of a new medicine or a product. As every stage must be properly documented, a typical R&D process generates huge quantities of documents. And in a lot of different formats: Word, Excel, PowerPoint, text files, scanned PDFs, image files and many more. […]
Document conversion software for enterprises: which solution should I choose?
What is enterprise document conversion, and how does a document conversion software impact your business? Enterprise document conversion is the process of converting different digital file formats into other formats so that they can be used in various business processes (standardization, customer communication, digital archiving, sharing and collaboration, etc.) and applications (CRM, ERP systems, etc.). […]
6 Rocking Reasons to Rethink Document Rendering
We have been rendering various documents into a unified format such as PDF for many years now. For many reasons: ease of use, accessibility, a wide range of functionalities and many more. In knowledge-driven industries, the need for standardization is often forced by regulators. For example, in Life Sciences, the introduction of the electronic Common […]