Keeping on top of regulatory requirements in life sciences is a full-time occupation, as the landscape is in a constant state of flux. The new demands each year are considerable. 2021 was already set to be a big year for compliance deadlines, and now the COVID-19 pandemic is driving new urgency around streamlining and accelerating processes and shoring up data quality.
In the European Union, IDMP data-based marketing authorization submissions are compulsory as of January 2021 for centralized procedures, and the new EU MDR will fully apply in EU Member States from late May. Brexit is having an impact on the supply of medicines and medical devices in and out of the UK. The Eurasian Economic Union is working towards unified quality control of medicines. The United States, Canada and China are continuing to make their own strides towards standardized electronic submissions and data exchange, as well as improved product traceability, meanwhile, as part of a global effort to ensure safer and more timely access to all kinds of medical treatments.
All of these evolving requirements put the onus on life sciences companies to stay close to the regulators, and to maintain sufficiently agile systems and processes to absorb each set of changes as they come along. In the best-case scenarios, organizations will be able to calculate the impact of emerging new requirements ahead of time and automate the cascading changes that are required.
Although life sciences companies have set an ambition to be smarter and more data-driven in their regulatory information management, with a sharp focus on integrating diverse data systems so that information can flow and be exchanged between them, too often these initiatives stop short of delivering tangible benefits because they don’t provide for process automation.
Pathway to Efficiency
RIM integration creates the channels for data to flow between systems, but there are no rules for automating what happens to that data—how it is processed, the conclusions and the next actions that it triggers. The true pathway to improved efficiency, accuracy and accelerated speed to market comes from the ability to understand the interdependencies between data, documents and processes, and to drive new process automation based on the latest regulatory intelligence.
Companies have made some progress towards impact assessment and streamlined change management in areas such as packaging and labeling, so that if there is a change to a substance or to manufacturing, these can be quickly and reliably reflected across all relevant regulatory documentation and patient-facing information. But they could go further.
The obvious next step to deliver additional benefits from integrated RIM is to apply it to changes to regulatory requirements globally—so that each incoming update is swiftly translated into practical implications and actions which can be automated to a significant degree.
Companies have long realized that the key to doing more with data, and saving on process repetition, is to integrate systems more tightly so that information does not have to be recreated numerous times. Adding a new system for each new requirement is costly, too, so the favored approach now is to adopt information standards and web services to exchange data.
While it is highly desirable to establish a high-quality master data set, and have ready access to a pool of regulatory intelligence to inform document preparation, the key to process transformation is a configurable automation engine.
This may be added on top of existing integrated RIM systems, to process data and deliver it to where it is needed—to drive alerts, or to ensure that the correct information flows into place for each particular purpose.
Moving beyond RIM data integration towards intelligence-driven process automation carries huge potential to simplify the lives of data workers while accelerating processes and reducing the scope for human error.
Applications could include managing the different regulatory specifications for what to include on labeling in each region, with the potential to streamline variation planning and delivery; optimizing local and global planning and change management/impact forecasting; and automated maintenance of foundation/master data and the cascading of changes to affected documents.
In the case of changes to a product master data item, the indication of a potential change could automatically trigger notifications of what the impact would be, before the decision is taken to action the change and set in motion knock-on actions in linked business processes.
Investment in RIM integration will start to deliver real returns when life sciences use integrated data as a springboard to automation that delivers tangible benefits. These come, not least, from a reduction of the significant time and risk associated with managing ever changing marketing authorizations.