The challenges faced by regulatory professionals are substantial. New products must be brought to market quickly and the pressure is on to turn projects around faster. Furthermore, regulations are constantly evolving, which means labeling and packaging must be updated. And yet there is no room for error, as patient lives are at stake. Add in the requirements of different national markets, multiple language versions, and multiple formats and the task of verifying labeling and packaging becomes even more demanding. Here we look at five key regulatory functions, according to a recent survey published by the RAPS organization, and how TVT document comparison software helps you meet the challenges.
1. Regulatory strategy
Meeting growth targets, managing risk, retaining employees, training and education, having tools in place to keep up to date with the evolving regulatory landscape, implementing regulatory changes quickly – these are just some key strategic challenges.
- Automated proofreading is fast and saves time. In a high-growth environment when productivity must increase, you can reduce your workload because TVT performs the proofreading task in seconds. You are freed of mundane manual proofreading and can dedicate more time to value-adding tasks like investigating and assessing regulatory changes, or training to keep abreast of new regulatory developments.
- Future-proof your strategy. TVT can be integrated into any digital workflow, on-premise or cloud-based (it is API-based, and therefore highly interoperable with other systems).
- The healthcare landscape is evolving, especially due to electronic labeling (e-labeling), which means you need a strategy for proofreading identical physical and electronic formats. You can load your online content into TVT for comparison with offline digital content by simply entering the URL. You can be assured of consistency in your different formats.
- TVT allows scalability both in terms of a larger work volume and the size of individual documents. TVT has the power to compare quickly even the largest documents, allowing higher productivity and output.
2. Submission Support
Your submissions must be timely and accurate. You want to get to market as quickly as possible in order to maximize sales.
- TVT reduces bottlenecks. You can expect faster turnarounds, fewer errors, fewer revision cycles, and more certainty in your submission. See here for more.
- In the EU, you need automated proofreading that supports your Quality Review Documents (QRD) and can work with all 24 languages. TVT does this, and not just in European languages but in all common world languages.
- In the US, TVT supports the Structured Product Labeling (SPL) submission format – the Health Level Seven (HL7) formatting standard for product and drug information. In Canada, TVT supports the Structured Product Monograph (SPM), and the language capabilities of TVT stand you in good stead for English and French versions.
3. Project Management
You can easily integrate TVT into any information management system and any on-premises or cloud-based workflow using TVT Connect – an Application Programming Interface (API). See here for more.
But TVT also promotes efficient project management in other ways: imagine multiple language versions of the same document. For instance, you can run a preliminary check of an artwork file (it can be in any document format) against the approved original document and immediately see any deviations. This is independent of whether you know the language or not, because TVT can proofread all common languages. You can then forward your reviewed copy with your comments and a report within TVT or your overall workflow system to the local subsidiary for further review and correction by a native speaker. This simplifies managing multiple language projects, especially across geographically remote subsidiaries.
4. Compliance
TVT is designed to promote compliance in regulated industries, and has features specifically for the healthcare environment (e.g. Stedman’s Medical Dictionary, a feature of TVT Spelling). But that’s just the beginning.
- You can benefit from validation support on-site through our validation package – it helps you to remain compliant with regulations on pharmaceuticals and medical devices.
- Your workflows are documented throughout. All actions are recorded, and you can generate and print out a final report, creating an audit trail.
- Schlafender Hase is ISO 9001:2015 certified for Design and Software Development for Regulated Industries. TVT facilitates compliance with FDA (21 CFR Part 11) and EMA regulations (Annex 11), and other regulations, including reading order verification for Section 508 (US) and the EU Accessibility Act.
5. Writing / Medical Writing
TVT is supporting medical writers everywhere across this very broad discipline, regardless of whether it is proofreading a 500-page report, a marketing brochure of several pages, or a one-page poster. Create your own custom dictionaries for your product-specific nomenclature, use TVT Artwork to detect color variations on that poster, or integrate TVT into a customized medical writing workflow, such as your Laboratory Information Management System (LIMS). If you are working with large tables and statistics, TVT will find even the smallest deviation between the approved original table and your copy. For more about medical writing, see here.
TVT makes life easier for Regulatory Affairs professionals because it takes the stress out of proofreading. But there are lots of other advantages. Read our blog How to Attract and Retain Regulatory Affairs Professionals for more.
