Dean Halliday has been working with customers in highly regulated markets for over a decade and specialises in working with the Life Science Industry. Ensuring that the related risks of manual proofreading and approval processes are identified and solved quickly and easily, allowing only approved content to be printed or published.
The Road Ahead: Exploring Regulatory Trends Shaping Med Device and Pharma in 2025
The life science industry is poised to undergo significant shifts, driven especially by new technologies in healthcare. Technologies are also driving greater transparency in supply chains. Other features of the industry landscape that we foresee for 2025 are a more globally harmonized regulatory framework.
Proofreading regulated documents in pharma presents unique challenges. Avoid the high risk of costly mistakes with best practices and by leveraging technology.
TOPRA Sponsored Webcast: A Non-Technical AI Introduction for Regulatory Affairs Professionals
AI is already being used in many Life Science applications, meanwhile Health Authorities are looking to regulate the use of AI. As a regulatory affair professional, it is essential to have an understanding of this technology.
In this general introduction to the field of AI, different uses of the term "Artificial Intelligence" will be discussed, and which might be desirable in a given context.
Inspecting Braille on packaging is important for compliance in the pharmaceutical industry. Automated proofreading supports you with Braille inspection.
Top Medical Device use Document Comparison Software
When the subject of proofreading comes up, most think of correcting written text in a document such as a book or a school essay. In the Medical Device industry, however, proofreading is a whole lot more than that.
Packaging and labeling can include many elements such as instructions for use, company logo, symbols and numerous other graphics, as well as a variety of different barcodes. Everything has a purpose and must be correct before a device goes to market.
Top Pharma use document comparison software to proofread labeling. Why aren’t you? When the subject of proofreading comes up, most think of correcting written text in a document such as a book or a school essay. In the Pharma industry, however, proofreading is a whole lot more than that. Packaging and labeling include elements such as dosage, instructions for use, company logo and numerous other graphics, as well as a variety of different barcodes. Everything has a purpose and must be correct before medicine is delivered to patients. Ensuring patient safety is of absolute importance. Whatever the format (including online and hardcopy/print), all versions must be true to their approved original throughout the entire lifecycle. Furthermore, content format (font, type size, etc.) must be compliant with local regulatory specifications. A mistake could cause a misprint resulting in a CAPA (corrective and preventative action), a recall, or even worse, a negative effect on a patient’s life. If your job includes checking or comparing documents for errors, you might not even realize that what you’re doing is actually proofreading. Why is document comparison software needed in Pharma? Proofreading is crucial in Pharma and serves as an integral part of the quality control process. Traditionally, this process has been manual, usually involving two people who check content line by line, item by item, sometimes with a third person verifying their work. Whether you are involved in Clinical Research, Submissions, Regulatory Affairs, Artwork, Marketing or Legal Affairs, using highly qualified professionals to manually proofread isn’t only very expensive, but also inefficient. Using a document comparison software eliminates the risk of human error. The software instantly identifies errors and inconsistencies in the documentation, labeling, packaging and other materials so users can correct them and prevent expensive mistakes, misprints and recalls. Deviations such as a missing character (ex: 1 mg instead of 10 mg), a missing dash (ex: take a tablet 12 times a day instead of take a tablet 1-2 times a day) or duplicated words (ex: “Do not not chew” instead of “Do not chew”) are some common deviations that can be easily overlooked by the human eye. For more information on how a comparison software can improve your work life, we’ve put together a list of the top 10 ways using a comparison software to automate proofreading makes your life easier. Why do top Pharma companies use document comparison software? Document comparison (or proofreading) software compares digital files with different layouts and in different formats (ex: Word to PDF) to catch any potential deviations early in the process. The software will instantly find, or “proofread”, any deviations between the two digital files (ex: spelling, font size, graphics, font style, barcodes, etc.) All you need to do is decide whether these deviations are acceptable or not. The software is very simple and easy to use: 1) Upload and compare your documents 2) Review and comment on any identified deviations 3) Approve the content Finally, an Audit Trail Report can be generated and saved to
Freyr Solutions Case Study- Achieving Ambitious Growth Targets with TVT
After implementing TVT, Freyr Solutions found the document authentication it sought, and saved time. This has been important to its continued growth trajectory.
Introducing TVT 12: A New Era in Compliance and Efficiency
With growing demands on regulatory professionals to ensure accuracy and efficiency, the newest version of the industry-trusted proofreading software, TVT 12 delivers enhancements that allow users to navigate complex document requirements with greater ease and confidence.
Introducing TVT 12: A New Era in Compliance and Efficiency
With growing demands on regulatory professionals to ensure accuracy and efficiency, the newest version of the industry-trusted proofreading software, TVT 12 delivers enhancements that allow users to navigate complex document requirements with greater ease and confidence.
The Game-Changing Features of TVT 12: A New Era in Compliance and Efficiency
TVT 12 is here!
This annual update is packed exclusively with new features and improvements from customer requests that support key industry initiatives, boost efficiency, and add even more speed and detail to your document reviews.
The Game-Changing Features of TVT 12: A New Era in Compliance and Efficiency
TVT 12 is here!
This annual update is packed exclusively with new features and improvements from customer requests that support key industry initiatives, boost efficiency, and add even more speed and detail to your document reviews.
