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Compliant Rendering

Compliant Rendering

Generate quality documents that meet compliance mandates




What? 

Use this centralized solution to establish, update and certify your organization's submissions management system

It’s a complex process to manage compliant eSubmissions. You have to follow certain format standards when validating and publishing your eSubmissions, like eCTD, and they need to comply with ICH-, VCH-, FDA- and other regional regulations. That’s why DocShifter has an integrated solution that simplifies lifecycle management for heavily regulated industries, like pharma and biotech, and makes the process of eCTD submissions easier.

This software solution:

  • Understands the governing specifications and makes sure all regulatory requirements are met.

  • Easily converts all your text-documents, spreadsheets and presentations automatically to ICH-, FDA- and ISO-compliant quality documents in PDF-format with the DocShifter Hi-Fidelity edition

  • Improves the quality of your submissions management system.

  • Is future-proof, scalable and ensures compliance with worldwide regulations.

  • Is your all-in-one centralized solution for electronic submissions (eCTD) that provides a flawless integration with Content Management Systems (CMS) and other business systems.

  • Reduces the cost of handling your compliant electronic submissions.

  • Automates document assignments to any folder, mailbox or CMS.

  • Contains high availability and load balancing characteristics that enable the processing of extremely large volumes of documents.

  • Increases efficiency and reduces risks of manual processing errors.

  • Automates document enrichments like headers, footers, logos, page numbers, PDF bookmarks and metadata (author, title, keywords…)

  • Performs advanced rendering, so that you can automate the conversion of your content to a format of your choice.

  • Fully supports Word track-changes, field-updates and comment-rendering.

  • Compiles separate (parts of) documents into one document.

  • Supports digital sealing, digital signatures and - timestamps.

  • Performs content compression to make files readable on mobile devices.

  • Has an optional sign-off functionality for a coordinated and secure approval flow.

 

PDF format conversion and transformation:

  • PDF optimization

  • PDF E6

  • Good clinical practice PDF

  • Full support for tagged PDF which allows for full accessibility by any type of user and for the re-use of page-based content

  • Long-term digital preservation using the reliable PDF/A file format makes sure files can be viewed on any system, allows to conveniently search on particular information and reduces storage costs

 

Ideal for the following solutions:

  • Controlled Documents

  • Submission management 

  • Quality management

  • Procedure Management

  • Regulatory Publishing

  • Dossier Management

 

Let's talk about your conversion problem

Wonder why the Hi-Fidelity module is your document compliance solution? Read this blog post or get more information about the Hi-Fidelity edition here. Or read here which enormous challenges life sciences companies face to respond to this increasingly complex regulatory environment. You can also contact us via info@docshifter.com and we'll set up a meeting to talk about your compliance issue.

Speed up regulatory submissions with our more efficient, integrated solution.

Customer Cases 

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