How connected compliance technology will improve pharmaceutical operations
Regulatory and compliance issues have weighed down the pharmaceutical environment for decades. While every organisation understands the need for compliance, the number of new regulations has burgeoned by 150% over the past five years – that is over 2,300 new guidelines issued annually around the world, or a new regulation announced every 22 minutes.
With more than 2,000 new local regulations issued by the FDA alone since 1998, providers and pharmacy practitioners are overwhelmed and under pressure. Add to that the fact that there are also global rules to apply simultaneously and it’s not hard to see why 80% of time and resources go to managing regulatory data instead of utilising it. Connected compliance technology (CCT) has a high potential to benefit pharmaceutical compliance processes.
Parsing the pain points
Pharmaceutical providers face multiple pain points related to compliance. In addition to juggling the astounding number of regulations, they must absorb the high staffing costs necessary to manage them.
Then there are the challenges of administering processes across organisational silos. Most pharmaceutical compliance issues apply to patient safety, information privacy, and billing practices, which are all traditionally managed by different departments. Stringent privacy requirements have led to a well-developed fear of sharing information, resulting in impenetrable verticals within enterprises.
Meanwhile, quality assurance staff must ensure the organisation and its quality management system are always inspection-ready. Achieving this status without sharing knowledge, insights, and feedback is a tall order.
CCT’s significant potential
Connected compliance technology is a modern way to break down organisational silos, save money, make better decisions, eliminate weaknesses, and improve compliance. To reap the benefits of CCT, pharmaceutical companies must develop a connected intelligence strategy that enables decision-making based on the deployment of accurate data.
A good strategy design would typically start with foundational automation to gather accurate data. Intelligent automation then handles processing of the data and predicts the impact of regulatory updates on company activities. The resulting access to insights and predictive analytics helps pharmaceutical companies make—and implement—the right decisions for the future.
The third phase entails deep automation, using artificial intelligence (AI), which learns from previous iterations, delivers highly accurate impact projections, and provides decision support across the organisation.
Benefits of deploying CCT
The advantages of deploying a connected compliance “ecosystem” include effective regulatory, safety, and quality functions blended with increased speed, efficiency, and accuracy. These outcomes are achieved by realising several specific benefits:
A single source of truth (SSOT): When data exists in various silos across a pharmaceutical organisation, decision-making becomes a challenge because not all executives operate on the same information. With CCT, different versions of individual regulations become a thing of the past. Users can operate with confidence that the information accessed via the company’s systems is accurate and current. The single SSOT model aggregates data from multiple systems to a single location, so that all insights and analytics stem from a distinct, updated reference point.
The ability to scale: For pharmaceutical organisations, the ability to scale is vital to counter growing demand. Balancing this challenge against regulatory compliance requirements is only possible through increased digital transformation. CCT allows organisations to scale their assets in key areas, such as the clinical, quality, regulatory, and safety functions.
Distribution of costs: Continually rising costs create significant problems for pharmaceutical enterprises. The ability to share and connect data across departments, platforms, and functions enables them to distribute the high costs of both decision-making and compliance more equitably.
Sharing the burden: Evolving regulatory requirements place a massive burden on pharmaceutical organisations. When quality, regulatory, and compliance functions no longer reside in silos, departmental burden-sharing leads to shorter development cycles, lower operational costs, and reduced compliance-related risks.
Implementing a CCT strategy
To deliver a successful CCT programme, pharmaceutical enterprises must invest, both in the people and the necessary technology. Identifying and acquiring the right enterprise software solutions and integration tools is a relatively straightforward undertaking. However, the human factor is more complex and requires a triple-pronged approach.
The first aspect of this approach is to develop current employees’ skills by including them in the project from the start: facilitate change management through internal workshops and provide training for all parties impacted by the shift. This process pre-empts dissatisfaction, prevents the loss of talented workers, and minimises the need to recruit in-demand CCT experts externally.
Initiate a complete cultural shift within the workplace to support interaction across existing silos. Encourage disparate teams to work collaboratively, make joint situational decisions, and merge internal processes across departmental lines.
Design a clear, unambiguous project scope. With the current, fast-changing regulatory environment, project teams need to know exactly how much raw pharmaceutical data requires transformation. Providing this information promotes short-term successes and maintains momentum.
Creating a competitive advantage
Implementing a well-constructed CCT strategy enables pharmaceutical companies to lower the costs and inconvenience of regulatory changes. Adopting new technologies and processes improves their ability to make good decisions more rapidly, keep up with compliance requirements, and bring new treatments to market faster.
About the author
Kari Miller is regulatory and product management leader at IQVIA. She is responsible for driving strategic product direction, and delivery of industry best practices and regulatory compliance solutions for quality management. Miller focuses specifically on translating market and industry requirements into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated Life Sciences market. She also is responsible for the Quality Compliance product roadmap, product partner relationships, and overall product direction. Miller earned a Bachelor of Science in Business Administration and a Bachelor of Science in Psychology from Marian College of Fond-du-lac, Wisconsin.
