The Global Regulatory Labelling and Global Packaging departments of AstraZeneca are headquartered in Cambridge, United Kingdom, and work closely together with internal marketing and packaging partners across the group to ensure high-quality, accurate and informative materials relating to the company’s products.
Materials must be consistent in terms of corporate branding and instill confidence in patients as well as key external stakeholders such as government agencies and healthcare organizations. AstraZeneca operates in a regulated healthcare environment and much of the material produced in the Global Regulatory Labelling and Global Packaging departments is subject to regulatory approval. This places the highest possible demands on accuracy and accountability.
Meeting the challenge through quality assurance best practices
The global teams consist of approximately 500 users, some of whom had already had experience with TVT. Over many years the solution from Schlafender Hase has already proved its worth for the Global Packaging team, assuring the quality of labeling and packaging in this strongly regulated industry. The next step was to extend automated proofreading across the company.
The catalyst for deploying an automated proofreading solution worldwide across all global teams to verify market product information was a labelling issue in one of the regional organisations. The earlier experiences with TVT were very positive, and so the teams were enthusiastic about how automated proofreading could reduce their reliance on manual processes. They saw the potential to gain quality assurance across the company. Furthermore, they recognised the benefits of a “right first-time” approach, and the possibility of reducing the strain and time spent on reading and re-reading text.
Global Regulatory Labelling required a solution that was intuitive and user friendly, and could be used on a wide range of materials. Beyond labeling and packaging, the solution had to be suitable for the quality control of text in marketing and promotional materials such as websites, presentations, brochures and direct mailing.
Choosing TVT®, the Text Verification Tool®
A timeline of 12 months was set to thoroughly evaluate a range of different automated proofreading solutions. The key milestones were:
Investigation of software capabilities
User testing and feedback
Engaging with the provider to ensure the solution precisely matched AstraZeneca’s needs.
Apart from the clear merits of TVT, a factor that gave Schlafender Hase an edge on competitors was the company’s experience in both the regulated pharmaceutical industry as well as in more commercially oriented applications such as marketing, advertising and promotion.
Martin Rous, Global Graphics Manager in Global Packaging, explains: “We wanted a tool that was easy to use and maintain, and one that was reliable and would support us in consistency of our branding and material. Above all, the tool should be suitable for integration into our existing quality control procedures.”
The decision was made to implement the TVT from Schlafender Hase.
In July 2021 TVT was implemented and written into standard operating procedures (SOPs) as best practice in quality assurance for the global operations of AstraZeneca.
As part of its SOPs, AstraZeneca now uses TVT for quality assurance in the development and management of core product information (CPI), market product information (MPI) and the global labeling business process (GLBP). It is used in conjunction with AstraZeneca’s own Quality Control Strategy for Market Product Information.
Martin Rous is highly satisfied with the solution from Schlafender Hase. “TVT meets all our needs and more. Since implementing TVT along with the TVT Artwork module, we can be more confident of our results, and that means less stress for our proofreaders. We can also do the job faster – confident we won’t miss any mistakes.”
The ability to increase output – up to 100% compared to before in performing quality control according to SOPs – has been one return on investment. Knowing the risk of a product recall has been further minimised is another. Furthermore, the time saved can be spent on other projects.
TVT has also had a positive influence on communication within the department and with internal partners, explains Martin Rous. “Tracking reports mean more transparency in processes and higher quality of our finished products. We can see and document any variances in versions and use the reports as the basis to further raise the bar on quality. In terms of best practices, we’re now where we want to be.”
Those who use TVT are very pleased with the tool. A survey within the company in 2021 produced an overall rating of 4.16 out of 5 stars (83 out of 100). 100% of users responded to the question on how useful they found TVT. Follow up responses pointed to the accuracy and helpfulness of TVT in comparing documents and finding mistakes that might otherwise be missed by the naked eye. Other respondents pointed to user friendliness and accuracy. “The comparison tool is perfect,” remarked one user.
“We’re very satisfied with the level of service from Schlafender Hase,” adds Martin Rous. “Whenever anyone needs support or wants tips, our partners at Schlafender Hase respond quickly and are very helpful.”
AstraZeneca is a global pharmaceutical company with a focus on drug discovery, development, and commercialisation in oncology, rare diseases, and biopharmaceuticals, including cardiovascular, renal and metabolism, and respiratory and immunology. It is headquartered in Cambridge, UK and operates in over 100 countries.
Find out more on www.astrazeneca.com