Why it’s time for pharma leaders to rethink quality

Pharmaceuticals manufacturers are facing increasing compliance regulations and challenges from global production. As technology enables greater quality control, leaders are taking steps to embrace a new quality 4.0 world of standards and processes.

In brief

• Regulatory scrutiny and global supply chain pressures are making quality a priority and a challenge for many pharma manufacturers.
• Legacy, paper-based processes cannot keep up with the pace, demands and changes modern medicine and health care are bringing.
• Manufacturers should consider seven key steps to transform their quality management systems.

What does the QMS landscape look like?

For decades, pharmaceuticals manufacturers relied on people-powered, repetitive manual processes from production to quality checks. But with the arrival of an AI-driven and connected world, a quality 4.0 approach is now crucial for efficiencies, the environment and to meet increasing compliance demands. For manufacturers, this now involves the re-imagining of production and quality assurance as a hybrid cyber-physical environment that can connect smart devices, equipment on the production line and people across multiple lines and sites. Cloud-based data systems, Internet of Things (IoT) sensors in production and big data analytics are all enabling the building of a quality ecosystem that can function, comply and report in near real time, but adopting this to stay current and relevant, means change. The challenge for manufacturers is now about a move from quality processes based on static recordkeeping to a cloud-first and integrated approach that powers predictive quality, operational efficiency and regulatory readiness.

Roadblocks to QMS adoption

Process change, despite the benefits, isn’t easy. Perception of cost is a big roadblock for many who have concerns over vendor management costs, as well as health monitoring, backups and crucial disaster recovery and cybersecurity infrastructure. Some manufacturers cite data security concerns and the limitations of their legacy tech stacks and platforms to manage the complexities of protecting patient records, clinical trial results and proprietary R&D findings – all of which ladder back to crucial compliance. In places like India, an EY survey of Indian pharma manufacturers found 70% of respondents cite the strictness of regulatory requirements as the biggest barrier to crucial digital adoption. As manufacturers in the East and West struggle with all of this, the slower pace of much needed adoption is doing something else to exacerbate the challenges: creating a continued and growing skills gap for staff and teams trained in emerging and fast-moving QMS tools and solutions.

Seven steps to transform QMS

To put into place the changes and investments needed to overcome these adoption roadblocks and more, pharma manufacturers should begin with some important steps:

1. Assess digital maturity:

This includes a comprehensive assessment across all production and quality processes to benchmark the sophistication and efficiency of data systems, governance and the overall quality culture. What is working, what needs to change and why? Begin with a current state assessment and future state target.

2. Rethink and reframe quality as a reputational contributor:

It can be culturally difficult to sell and roll out a process change that is perceived as expensive for the bottom line, so work to align leadership and business unit leaders around the crucial role QMS plays in long-term reputation. Quality is foundational to efficacy, customer loyalty and patient satisfaction.

3. Align across functions:

It’s important to include quality, manufacturing, compliance, IT and supply chain teams in understanding quality objectives and embracing the changes, investments and timeline to affect success. Shared ownership avoids siloed – and ultimately unsuccessful – deployment.

4. Conduct technology architecture alignment:

Think through how data flows between your technology systems and the coordination of release schedules and maintenance of all systems. As additional technology systems are brought online and processes are automated, prioritize integration into your centralized QMS landscape.

5. Prioritize data quality and integrity:

Build systems with audit trails, version management and control, and robust documentation validation throughout to enable ongoing assessment and continuous improvement.

6. Scale with governance and analytics considerations:

Quality 4.0 is moving fast, so manufacturers must plan for flexibility and growth using key performance indicators (KPIs) to monitor progress and success, to flag anomalies and provide the data to drive improvements in process and outcomes.

7. Keep people at the center:

Quality transformation is more than process and technology – leadership must consider the pace and ask of teams and equip them with the opportunities for understanding, buy-in and skills development.

Nikita Patel, Mukul Shukla, Munish Chhabra and Gunjot Rana also contributed to the content and development of this article.