One size does not fit all especially in the space of regulation for the life sciences industry. Different regulatory dynamics require different processes and with continually changing requirements it is critical for pharmaceutical companies to adapt to remain compliant, cost-effective, and nimble. Given the ever-evolving regulatory requirements the industry needs a solution that can achieve key process improvements through digitization, agile adoption, and cross-functional collaboration while adhering to the rules.
While individual organizations and stakeholders are working on ways to satisfy regulatory and compliance stipulations, we need industry-wide collaborations to come up with a comprehensive solution that addresses specific requirements and bypasses bottlenecks. To move towards that goal, industry players are now coming together to discuss pertinent business challenges and regulatory issues. Here we discuss key regulatory pain areas that need attention and corresponding solutions that can benefit the industry.
Dossier Change Management
Lifesciences firms spend too much time ensuring the dossier version is up-to-date for the health authorities. The reasons range from changing regulatory requirements to a dearth of cross-plant, registration, and product information conforming to end-to-end dossier management. What is current is not always used. Not just changing information, sometimes, the need to translate from a foreign language becomes a barrier.
Glorified unstructured data that is a dossier needs to be structured, and therefore establishing a robust data-document connection is a must. Analytics can help us streamline submissions and find what needs updating. The goal is to identify, analyze, and validate data.
Blockchain, too, might help accelerate the journey from document-centric to data-centric — which should take five years or so — following a careful identification of the use case.
RTQ and Business 4.0™ Tools
Digitization and process improvement hold many opportunities in response-to-questions (RTQ) workflows. A standardized central repository can be created by applying an intelligent extraction layer that ensures data validation and, analytics can be used to identify trends in health authority questions. Moreover, AI and machine learning can be harnessed to implement intelligent automation and enable responses that are more effective. All that will increase transparency, trust, inventory control, and, eventually, consistent productivity.
Further, there should be flexibility to modulate the approach. A combination of automation and human intervention works best. Robots, AI, and business process management (BPM) can drive efficiency in compliance, aided by computation-as-a-service, Big Data platforms, cloud-native applications, IoT and connected ecosystems. The potential use cases include data quality improvement with NLP and text mining for verification, data enrichment, predictive analytics and an integrated ecosystem for data accessibility.
Technology needs to be deployed in conjunction with process improvement to break barriers to cross-functional collaboration and drive innovation. Furthermore, it is important to note that modular and flexible architecture supports those initiatives and delivers the best results.
Regulatory Intelligence and Label Management
Regulatory changes often translate to higher costs, have a significant impact on quality, and reduce operational efficiency. The way out – regulatory intelligence – could prove to be costly. AI-driven mapping and automated impact analysis can provide the right information and insight and generate compliance reports, thus becoming a single source of global regulatory intelligence.
BPM can simplify label management, maximize efficiencies, identify process bottlenecks, reduce compliance risk, and ensure greater accountability. Merck, for example, uses BPM Hub to avoid back and forth emails.
Future-ready labeling workflows must feature structured content, free data flow from CCDS to local labels, and AI.
Event triggers are needed for both new applications and routine ones, such as license renewal. The goal is to mitigate the risk of missing a milestone, track progress, and view multiple plans. Most tools now are designed for complex planning, sometimes involving more than 2,000 tasks. They need to be simple and intuitive, where online collaboration can bring order to the chaos.
Using wrong templates, authoring multiple copies and, the inability to find the correct document are hurdles to effective authoring. Precious time is spent on formatting content and providing MS Word training making structured authoring the need of the hour. To further that cause, NLP should be used to identify similar meaning sentences rather than finding an exact match to address duplication of content.
It has become imperative that stakeholders discuss the conceptualization of a common industry platform with emphasis on end-to-end regulatory solutions spanning optimization of regulatory processes to life-cycle maintenance – not tools in isolation, but harmonized systems, business process reviews, and an overhaul of the management and usage of information.
Enterprises must consolidate the regulatory compliance processes into a centralized and secure environment. Centralization will make seamless access to data possible via cloud. Right information will reach the right stakeholders at the right time through the right platform.
However, this cannot be achieved without the latest technology. AI and robotics are essential to structured data collection, and it is time life sciences industry makes strategic investments in these next-generation technologies to drive superior business outcomes.