At this year’s DIA Global Annual Conference, ArisGlobal presented an Innovation Theater session, “Getting More Value from Your Data Through a Unified, Cross-Department Platform.” Wim Cypers, Senior Vice President of Regulatory, highlighted use cases where automation can be used to improve business processes to enhance data quality and improved business process efficiencies. He shared how a unified platform can reach beyond regulatory and how regulatory data can improve compliance across your life sciences organization. For those that couldn’t attend this session, this blog shares some of his collective insights
Industry Trends: Moving from Documents to Data
Over the past 50 years, the evolution of regulatory information management has undergone significant change, moving from the paper submissions era of the ‘70s, to the digitalized era of the ‘80s and ‘90s, and onto the document exchange era of the past twenty years.
In the past several years, regulatory departments have been investing in regulatory information management capabilities to overcome long-standing challenges such as:
- Lack of centralization of approved product data
- Poor collaboration with affiliates and other resources
- Manual ways of sharing or extracting information from other departments
- New standards compliance (such as xEVMPD, IDMP, and UDI)
- Costly and time-consuming upgrades to avoid technology obsolescence with changing regulations
The data in such RIM systems is vitally important, especially as there is now increasing regulatory agency demand for quality metrics to assist them in determining the state and quality of a product and facility. Given this focus on metrics, regulatory departments are now looking at how to converge disparate regulatory information management (RIM) capabilities; implementing best practices for data governance roles and responsibilities; and creating formal information architecture aligned to data standards for effective documentation, storage and sharing of regulatory information.
Improving Data Quality
The emphasis that regulatory authorities place on quality systems creates important considerations for the regulatory department within life sciences organizations. Looking beyond data submission compliance as the only end goal, regulatory departments are now asking “how can we deliver quality data faster and at lower cost, and that is in compliance and links departmental data together?”
Regulatory departments have historically been the gateway for sharing data in a structured format with the agencies, and the responsibility to share quality metrics data will most likely fall on them. This means going beyond compliance by establishing a platform from which the rest of the organization can consolidate data and proactively measure metrics internally. With this approach, regulatory departments can provide the rest of the organization with the insights they need to determine which manufacturing sites are not meeting the quality metrics cut-off and are therefore potentially at risk of an inspection.
Alignment Between Data and Documents
Within this expanded role, regulatory departments need harmonized processes, a central technology platform for data collection, workﬂow collaboration and electronic gateway communication to meet health authority structured data exchange objectives. This is where automation capabilities can perform an important role.
Methods such as structured content authoring, which automatically populates routine documents with already-approved sections of content and approved data, enables more collaborative contributions and promote re-use.
The ability to automatically generate a document based on data, and to separate a document into building blocks for re-use these across multiple documents ensures that data is aligned with document content.
Using Regulatory Data to Benefit Your Organization
As regulatory departments transform their operations to more productively meet today’s challenges and plan for those in the years ahead, success will be realized in marrying the concepts of documents and data to create a single source of truth as opposed to just extracting data from documents. By using existing data that resides in systems of clinical, R&D, manufacturing and regulatory departments, regulatory departments can create a uniﬁed underlying source of product and process information – a central data hub that is data-standard agnostic and yet can cater to multiple submission requirements.
From this underlying source, regulatory can digitally and automatically author dossier documents using natural language generation technologies. The same underlying data can also be used to cater to multiple data submission requirements (such as XEVMPD, IDMP, SPL and UDI).
Under this transformative approach, the benefit to life sciences companies is significant. Increased compliance, better alignment between data and documents, improved efficiencies, and the ability to focus on what matters. In the end, this all delivers improved products and patients.
We encourage you to view our recent on-demand webcast for more details on Next-Generation Structured Authoring: Seamless Synchronization between Data and the Document. Have any questions? Send an email to [email protected].