ONSTYLE

onstyle

STANDARDIZED AND COMPLIANT WORD DOCUMENTS IN SECONDS WITH ONSTYLE

OnStyle automatically checks and fixes Word documents for compliance.

Submission-ready Microsoft Word documents on time with automated checks and bulk fixes for typical formatting and linking/referencing issues.

Having everyone at a biopharma company precisely following the latest, strict document-standards is nearly unachievable. Also, checking compliance with both company standards and industry regulations takes a lot of time. Clearly, an automated solution is needed that manages all Word documents and makes them standardized as well as compliant with a single click.

SUCCESSFULL DOCUMENT FORMATTING

• Focus on content creation and make your formatting tasks as easy as possible.
• Edit faster with regulatory-specific, built-in authoring tools in Microsoft Word.
• Use tools that ensure that you always use the right style and formatting.
• Use built-in industry (e.g., FDA, EMA) and company-related standards. In an organization use central management for standards.
• Automate validation. Automation makes it possible to validate your documents as soon and as often as you can.
• Automate issue correction to reduce the risk of noncompliance. Use controlled automation.
• Automate the change to a new standard or to multiple formats for multiple clients or health authorities.
• Create PDF-ready documents by eliminating known errors. Most PDF conversion failures are caused by inconsistencies and various formatting issues in the source Word documents.

HOW DACHS CAN HELP

Compliant Documents with OnStyle

Proven Software to Comply with Company Standards and Health Authority Regulations
Fast Authoring, Automated Validation, and Improved Document Quality
Standardized and Compliant Documents in Seconds
Customized Features for Life Sciences Professionals

Edit Faster

Regulatory-specific, built-in authoring tools, making the whole process fast and easy. Mundane tasks that took hours now take minutes.

Enforce Style and Formatting Rules

Customizable style rules in line with your in-house or regulatory guidelines. Industry document formatting standards (e.g., FDA, EMA) are already built in; additional company-related standards can be easily integrated. Every author follows the same guidelines. Layouts can be defined for paragraphs, headings, tables, abbreviations, capitalization, hyphens/dashes, bullets and lists, spelling, numbers, table/figure numbering, page headers/footers, etc. Central management.

Automate Document Validation

Comparison of documents to standards is achieved with a single click. All issues are listed and easy to navigate to. OnStyle finds and navigates you to all deviations from standards in the document. Focus on high value authoring and reviewing activity and deliver fully compliant content on time. Automation makes it possible to validate your documents as soon and as often as you can.

Reduce Risk of Noncompliance

Fixing formatting issues: controlled, automated fix of the chosen issues. Automatically located issues can be corrected with a single click, and bulk correction is also available. You can choose which issues to fix, or you can fix all at once. You can submit compliant documents faster and easier.

Automate Change to a New Standard

Same content in multiple standard formats with a single click. You can change the whole document’s layout for multiple health authorities or clients.

Save Time and Effort

Automated checks and fixes speed up authoring and reviewing. OnStyle helps automating all forms of compliance with company and external regulations, therefore submission deadlines can be met easily. Instead of editing documents for hours, the focus is back on content creation, making processes significantly more efficient.

Ease PDF Conversion

Most PDF conversion failures are caused by inconsistencies and various formatting issues in the source Word documents. Create healthy documents, eliminating known errors: preparing documents for easy and fast conversion to high-quality PDF (smaller files, faster conversion). No more discrepancy between the original Word and converted PDF documents: enjoy perfectly consistent PDF generation.

Enjoy Multiple Language Support

Dedicated tool with special configuration principles. Languages such as e.g., Japanese, Chinese.

ONSTYLE AS A MICROSOFT WORD ADD-IN

Significantly Speeds Up Document Authoring

With OnStyle you can:


• Use the configurable OnStyle Ribbon for your specific needs.
• Edit faster with customized authoring tools and predefined settings.
• Update documents to the newest standard or to multiple formats with a single click
• Keep your frequently used symbols at hand.
• Insert tables fully formatted following your predefined requirements.
• Guarantee correct captioning for tables and figures.
• Use standardized header and footer management with Document Property control.
• Enjoy Smart Paste features.
• Insert preformatted TOC and LOT, TOF with a single click.
• Benefit from intelligent management of orientation change in tables.

word-formatting-problem

PROFESSIONAL SOLUTION FOR MICROSOFT WORD DOCUMENTS

Helps You to Comply with Predefined Formatting Standards
• Enforces style and formatting rules in Word documents for compliance.
• Provides powerful functions to apply standard styles and formatting rules to a newly created document or to correct your existing documents
Automatically Identifies and Fixes Compliance Issues
• The validation tool identifies the deviations from the required standards. It inspects and corrects the formatting of large documents with a few clicks.
• The tool navigates you to the issues in the document and gives guidance for correction.
Ensures Consistent PDF Rendering
• Unused bookmarks are eliminated.
• Only standard styles are used.
• Embedded objects converted to images.
• Standard image resolution and file format are used.
• Only valid cross-references are in place.

50+ AUTOMATED WORD CHECKS AND FIXES AVAILABLE NOW

•Abbreviations

•Blue Text Not Linked

•Cross-Reference Issues

•Embedded Object

•Headings

•Hyperlinks

•Images

•Incorrect Caption

•Nonstandard Page Layout

•Protected Document

•Tables

•And many more…

SIMPLIFY YOUR REGULATORY SUBMISSION

Regulatory document submission: specific formats, styles and consistency under time pressure. OnStyle helps with the correction of the most common problems in your documents before the PDF conversion.

How to make submission content preparation easier and reduce regulatory content creation issues?

Standardized authoring: You have your document templates, so let’s make it easier to follow them with specialized authoring tools that help authors comply with standards through specific features tailored for your needs. Ensure that everyone is following the same guidelines.

Quality check from the very beginning: Check documents for formatting and styling issues throughout the authoring process from the very beginning. Eliminate manual reviewing and accidental mistakes by using an automated tool that identifies and navigates you to all issues found in the documents. Automation makes it possible to validate your documents as soon and as often as you can. This saves time and reduces the risk of non-compliance.

Fixing formatting issues before rendering: Fix formatting issues in the Word document to easily generate technically compliant and submission-ready PDF documents. Use an automated tool for fixing the chosen formatting issues. Fix these issues as early as you can in your submission preparation process.

Comply with the different technical requirements of multiple health authorities easily: Same content in different format for different authorities with only one click. Once you have a document complying with one health authority’s guidelines, it may need modifications to comply with another health authority’s submission criteria. You can change the whole document’s layout with only one click to follow the guidelines of the chosen authority, or you.

Apply new requirements faster: It is easier to follow changing regulations if a regularly updated software is following them. If your software is maintained by the vendor, it can faster comply with any evolving requirements.

Perfect rendering: Ideally the original document is authored in a way that minimizes the need for adjustments at the rendering stage, but the rendering platform is a critical part of the content creation process that is often overlooked. Modern rendering solution allows you to generate technically compliant, submission-ready renditions earlier in your submission content preparation process. This way, you don’t have to wait until the last minute to validate the PDFs. This approach drastically reduces the risk of non-compliance and speeds up time-to-market.

WHY TRUST DACHS

20+ YEARS OF DOCUMENT MANAGEMENT EXPERIENCE

DACHS has supported 100 000 + submissions in the last 10 years and has 20+ years of experience in the field of document management for Life Sciences. DACHS has provided software development and support in the fields of drug development, clinical trial documentation and tracking, and regulatory submissions as well as drug manufacturing, packaging, and labeling.

DACHS, THE SUBMISSION EXPERT

DACHS’ professionals can reliably provide as well as flexibly adapt their services to changing requirements in a regulatory environment. As trusted partners of Industry Leading Pharma Clients, we are fully committed to our clients’ best possible business outcomes.

ZOLTÁN KOVÁCS

Solution Delivery Manager

+41 61 508 0300

CONTACT US FOR FURTHER DETAILS