Many organizations take a reactive approach to compliance management. This means corrective action isn't taken until the organization is facing an audit, consent decree, or even a product recall. A reactive posture is costly, especially when regulatory fines, expensive recalls, and reputational damage is taken into account.
Regulatory change is a constant challenge in the pharmaceutical industry. Pharmaceutical companies can expect new risk and compliance requirements based on laws, regulations, and guidance. As organizations struggle to balance a mounting number of existing requirements, looking ahead to an uncertain future can seem daunting.
The key to future-proofing pharma compliance is making risk mitigation a strategic, organizational goal which informs management decisions. This change can save your organization from the costs of reactive compliance. By adapting to best practices and simplifying systems, you can drive proactive compliance.
How to Future-Proof Pharma Compliance: Build Flexibility and Simplicity In
It’s no secret that pharmaceutical companies are spending more on compliance than ever before, and this spend isn’t necessarily translating into effective risk management. Noncompliance warnings in the industry have increased dramatically in the past five years, which Maria Gordian and Jason Evers of Bain of PharmExec attribute to “multiplying” regulatory requirements and increasingly complex organizations and portfolios.
These regulatory pressures have a measurable impact on bottom-line profitability for organizations in pharma. According to research published in the Harvard Business Review, the return on investment (ROI) for R&D activities has "declined substantially since 2010 from 10.1% to 3.7%." Since 1950, the ROI of R&D has halved approximately every nine years.
While it may seem proactive compliance could further stress profitability margins, future-proofing risk does not need to be complicated. Even pharma organizations that are currently building quality management systems or correcting compliance issues can future-proof regulatory risk by building flexibility and simplicity into processes. This approach can save your organization a great deal of future cost, rework, and stress.
Tactic 1: Adapt to Best Practices
As regulatory guidance, data analytics, and other sources of insight inform change, your organization should adapt your existing quality management system (QMS) to these best practices. If your existing QMS is best described as a rigid dinosaur, your organization is definitely not future-proof and will struggle to get ahead of compliance. The time is now to create flexible systems, which could be inspired in part by the ICH Q10 guidelines.
Guidance for pharmaceutical quality systems from the U.S. FDA, EU, and Japan is informed by the adoption of the ICH Q10 “Pharmaceutical Quality Systems.” The ICH guidelines were specifically designed for the pharmaceutical industry to enhance the scope of quality management systems across a system of four pillars:
- Process and Product Monitoring
- Change Management
- Management Review
The PCH model can help organizations achieve more adaptable QMS with guidance for:
- Management review informed by real-time data collection
- A strong emphasis on risk assessment and product risk portfolios
- Creating automation in the QMS and business processes
- Centralized data housing for process monitoring and event traceability
Your QMS should be informed by real-time data collection for traceability throughout business processes and comprehensive risk management. Management should be able to perform review based on these insights and drive automation throughout the end-to-end QMS. If your system lacks automation, visibility, or speed, it may be a dinosaur and challenging to adapt in real-time to emerging best practices or regulatory requirements.
Tactic 2: Simplify Systems
Keep QMS as simple as possible. Systems which are built to capture every possible scenario can complicate processes and introduce the need for process revalidation. To create an adaptable culture, your QMS software and systems should be based on simplicity and scalability to change in real-time as needed.
ISO 9001:2015 offered many insights into the art of simplifying systems, which include:
- Leadership Involvement in the QMS
- Simplified Language
- Common Structure and Terms
- Aligning QMS with Strategic Objectives
The standard also introduced new requirements for change, which include guidance for the planning of changes (6.3), operational planning and control (8.1), design and development changes (8.3.6), and the control of changes (8.5.6).
As regulatory requirements evolve, it is natural that systems will need to change. This is true for a lot of pharmaceutical startups and scale-ups. ISO 9001 organizations are required to execute change in a “planned and systemic manner”--such as PDCA cycles--and consider the possible outcome of change.
A process-based approach of plan-do-check-act cycles (PDCA) is far more difficult when QMS are unnecessarily complicated and prematurely scaled to meet every possible scenario. Instead of simply having to scale the system to meet new requirements, you have to perform extensive configuration and impact assessment. The key to future-proofing compliance is, in part, found in simple QMS systems which can quickly scale to meet new requirements systemically.
Tactic 3: Don't Get Creative
If your organization is ever subject to an inspection, you don’t want to have to translate your systems to inspectors who show up. Creativity is a virtue, but it’s not a wise approach to risk management and compliance. Bigger and more specialized systems are not better in the pharmaceutical industry, especially when these systems veer far from widely adopted guidance and standards.
QMS can offer the benefit of introducing simplicity to your pharmaceutical organization. It can centralize policy, processes, and procedures. It can improve communication, and create a structured approach. A QMS can improve CAPA, risk management, and management review. While a highly creative approach to QMS design or implementation may seem like a competitive advantage, it almost certainly isn't.
A QMS should fit widely adopted standards for the pharma industry which make sense to third-party inspectors before your organization is subject to review. The QMS should also match your business's processes and document management needs and regulatory requirements. More creativity generally translates to more risk and complexity.
Are You Compliance-Driven or Quality-Driven?
Compliance is an enormous cost and pressure in pharma. The requirements to check the boxes for compliance are steeper than ever, which is why many organizations face the consequences of taking a reactive approach to fast-changing regulatory requirements. By creating a flexible and straightforward executive compliance strategy, your organization can effectively future-proof against emerging regulatory requirements.
Scalable QMS carry more benefits than just greater agility in the face of constant regulatory change. Simpler QMS can introduce more transparency and allow pharma organizations to create a culture of continuous improvement based on real-time management review. The result is an environment where compliance is achieved, but quality is what truly drives your organization.