A quality management system can help your life sciences company deal with new EU regulations and cope with the demands of data harmonization.
Although the life sciences industry is already heavily regulated, that burden is steadily increasing. At the same time, pharma companies generate ever greater quantities of data, that form a mine of important information but can easily become overwhelming.
As the EU introduces new directives, seeking to standardize the way medical devices are regulated and clinical trials conducted, it’s tempting to focus on the headaches these rules create for the sector. However, they also provide an added impetus for companies to harmonize how they collect, manage and use data.
A single, integrated quality management system can help life sciences organizations cope with regulations, meet compliance requirements and improve productivity, by dealing with information more effectively.
What’s Driving Data Harmonization?
The pressures of regulation are a major reason why companies have started to confront the challenges of data harmonization.
Earlier this year, the EU published its new European Medical Devices Regulation (MDR), which will be implemented over a three-year transition period. The MDR aims to ensure that all medical devices are safe and work properly, by introducing stricter requirements, standardized across member states.
Your business will be expected to refer devices for independent assessment by a pool of EU experts, trials will be controlled more tightly and the role of Notified Bodies will be overhauled, so that companies are audited more closely.
The regulation will place extra responsibilities on manufacturers to collect data about quality and safety when medical devices are intended for the EU market. Businesses will be required to trace products to the end user, via unique device identifiers (UDI), and survey their performance, in order to implement improvements quickly.
This process will rely on various databases for clinical investigations, product registration and vigilance, under the auspices of the EU Commission, using its new EUDAMED information system. Suppliers will be expected to submit complaints via EUDAMED’s electronic reporting solution, whose emphasis on gathering and analyzing information is likely to require extensive data harmonization.
The EU’s regulations on clinical trials have also changed, in an attempt to harmonize requirements across the market. Rather than process separate applications to different member states, sponsor companies now submit a single application, even when trials are conducted across several countries. And the way that trials are monitored and reported has been standardized too.
The new rules will require your company’s quality management system to deal with data effectively and maintain higher standards of conformity and traceability.
Additionally, the US Food and Drug Administration (FDA) recently announced a 10 point security ‘toolkit’, addressing areas of vulnerability in the medical product supply chain. The toolkit aims to encourage best practice across the global marketplace and the FDA says it will be used by ‘stakeholders and regulators’ around the world to protect consumers, forming another powerful driver for standardized information.
Rising To The Challenge
The emphasis of the EU’s new regulations is on using data to ensure quality, safety and reliability, and many of the challenges your company is likely to face as a result will involve dealing with that data in an efficient, modern way.
Data harmonization means standardizing the way that information is collected so that it can be moved and shared more easily, from the inception of a product, through to its market launch and beyond.
In life sciences organizations data is often stored locally, by methods that work for the immediate task at hand and suit a particular system. The industry now has to get to grips with joining up the way information is treated by different departments ‒ breaking down silos to use the popular term ‒ and integrating it with regulatory requirements.
To take an example, businesses should look to identify their products consistently, right from the earliest stage of development. A unique, consistent identifier allows a full audit trail to build up during research and development, right through to manufacturing. This means that all information is already assembled by the time you apply to authorize the product.
With the EU’s requirement for a distinct UDI, the product’s traceability can now extend beyond its sale, providing your company with a wealth of valuable data about how it performs for the end user. Data harmonization will be necessary to navigate the new databases and turn the analysis into useful insights.
The emerging Identification of Medicinal Products (IDMP) standard will also require complex, specific sets of information to enforce standardized specifications for medical products. IDMP provides another incentive to implement a consistent method of managing data across all the operations in your business.
The pressures of regulation mean that it is necessary, and not just desirable, for life sciences companies to look at data harmonization. The good news is that integrated, effective use of information, via a robust quality management system, has many additional benefits.
Data Harmonization and Quality Management
Quality management has been traditionally seen as the responsibility of a specific department, whose job was to apply different criteria to the separate functions of a business. With the right quality management system in place, it’s possible not only to integrate it with processes across your company, but also instil an organization-wide culture that emphasizes quality.
The first step is moving away from paper-based processes and using the digital tools that are now available to life sciences organizations. It’s equally important to implement a harmonized system, so that departments work smoothly together and avoid duplication.
An effective quality management system will be integrated with each step of production, from research and development onwards, automatically detecting and correcting problems. The software collects data, then analyzes it quickly and accurately in order to guide decision-making and help you resolve difficulties as they arise.
With more stringent requirements around traceability, performance and safety becoming mandatory, a unified quality management system allows your company to harmonize its data automatically, so you can comply with regulations, lower risk and fine-tune the performance of your business.
- The increased burden of regulation in the life sciences industry is driving businesses to think about how they cope with data harmonization.
- The EU has issued new directives, standardizing the requirements for medical devices across Europe and harmonizing medical trials, that will place stringent new responsibilities on companies to provide data.
- The pressures of regulation make it even more important for life sciences businesses to treat data in a consistent, joined-up way. Departments should work smoothly together and avoid duplication.
- A unified quality management system can help your business comply with regulation, lower risk and fine-tune its performance, by harmonizing its use of data.
Discover how a quality management system can help your company deal with regulation and boost productivity. Download The Enterprise Quality Management System Handbook: Supporting a Quality Culture Across Your Business