The Importance of File Format Preservation in the context of Archiving
File Format Preservation: What is it? File format preservation refers to the act of maintaining the integrity and accessibility of digital files over time. It involves ensuring that electronic files can be read and understood by both current and future computer systems, even as technology evolves. The goal of file format preservation is to ensure […]
4 Situations You Probably Faced in Regulatory Operations (and practical tips to overcome them)
For this month’s edition, we knocked on Daniel Capion‘s door. Daniel is a documentation expert with +20 years of experience from biotech, mid-sized and big-pharma industry as well as medical device knowledge. We interviewed him on 4 situations you have probably faced yourself in regulatory operations, and practical tips to overcome them. Enjoy the read! Challenges and […]
Regulatory Professionals Community on LinkedIn
Get the latest updates & trends in Life Sciences in our free Regulatory Professionals Community. Tips & tricks for regulatory submissions, eCTD 4.0 and many more. Join our free Accelerating eCTD submissions LinkedIn newsletter to receive monthly tips and tricks. So far, we have published: Are there any specific topics you would like to read […]
eCTD 4.0: Key Changes & Impact on Submission Content Preparation
Who is (unfortunately) old enough to remember this? Date: March 2007. A submission. 500 binders for Module 5, 60 binders for Module 4, 30 binders for Module 3, 10 binders for Module 2, and 2 or 3 binders for Module 1. In total 600 binders, each 300-350 pages totaling about 200,000 pages. Each box contains […]
Creating the right environment for structured and unstructured data to co-exist
There’s a lot of talk about structured information and how it will solve all our problems with regulatory submissions. If you look at initiatives such as IDMP and EMA’s Digital Application Dataset Integration Project (DADI) or further back, FDA’s Structured Product Labeling, there are good examples of health authorities getting at least some information into […]
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 […]