A regulatory submission for a Healthcare or Life Sciences product includes all sorts of documentation and information that is submitted to a regulatory agency for:
CTD is a well known term in the Life Sciences industry, and stands for Common Technical Document. This internationally agreed format contains a set of specifications developed by the European Medicines Agency (EMA), the Food and Drug Administration (FDA) and the Ministry of Health, Labour and Welfare.
We are pleased to announce the release of DocShifter 6.1. This updated version contains a slew of powerful new features. Read on to learn more about the upgraded DocShifter enterprise content transformation platform.
In the highly regulated life sciences and biotech industry, companies are forced to comply with countless rules and regulations across all business aspects. The myriad and complexity of regulatory requirements has increased sufficiently over the last few years and is expected to grow even more in the future. Using an efficient quality management system helps companies to simplify ICH-, FDA- and ISO- compliance. Read more
DocShifter, an integrated server transformation platform that converts any digital document or data source to any file format, including text, image, audio and video, has released DocShifter 6.0, a new platform with improved Docgen, validation suite, and HI-FI module for users. With the newly unveiled update, DocShifter 6.0 will now provide people with one centralized solution, fully integrated into any Content Management System (CMS), allowing automated format transformations.
‘A comprehensive document conversion tool capable of automatically converting any digital documents into any format that can be easily read and searched in any extension’. This is exactly how leading B2B software directory FinancesOnline described our system in their brand new review. In fact, experts were so pleased with the functionality of our system that they awarded us two of their best productivity awards.
The eIDAS Regulation was set out to enable convenient and secure digital transactions in all EU member states. Are you wondering how your company can adhere to the eIDAS Regulation? We will guide you through the eIDAS Regulation in eight bullet points.
We added a new module to our range, called the Hi-Fidelity module. This module functions as an overall regulatory compliance solution. This module allows the rendition of quality documents in compliance with ICH-, ISO– and FDA–guidelines. DocShifter takes any input format (Word, Excel, PowerPoint, PDF…) and transforms them into compliant documents. With this module it is possible to add: headers, footers, logos, bookmarks and paging to your documents.
1. Fast implementation time
The setup of the sealing solution is very rapid, be it with a hybrid architecture or as a full cloud service. The most time-consuming elements are in the integration with existing systems, requiring input and possibly integration efforts from internal IT teams. Due to the standard and flexible ingestion possibilities DocShifter offers, the need for custom coding remains very limited.
Most companies are not demanding when it comes to the file formats they use. They just use the most common file formats as the logical extension of their software tools. The best example is the Microsoft Office package. Although Word is a good program for word processing, text editing and file formatting, a Word-file (.docx) is not the best suited file format for storage, archiving, sending sensitive and private data, and internet sharing purposes. Read more