After a busy year adapting to the impacts of the COVID-19 pandemic, a reenergized focus on quality management has come to the forefront for many life sciences companies. Medical device manufacturers had to maintain quality and compliance with ramped up production to meet high demand, pharmaceutical companies tested medicines for efficacy against the virus, and biotech firms pushed resources toward vaccine development. This has propelled 2021 life sciences quality trends, such as building a culture of quality, a renewed emphasis on risk-based thinking, digitizing and integrating data and utilizing analytics, and improving vendor management. These trends have emerged to help keep life sciences companies moving forward with efficiency to ensure lifesaving medicines and therapies can consistently and effectively reach customers and patients.
2021 Life Sciences Quality Trends
Trend #1: Building a Culture of Quality
It is imperative to ensure that quality is seen not just as a task executed by an organization’s quality department, but instead as a cross-functional competitive advantage for a business. Across an organization, all employees should understand the importance of quality. In order to build a culture of quality, employees should be consistently involved in quality management.
Progress can first be benchmarked using a gap analysis to discern the current state of understanding of quality initiatives, and further improved through process training, cGMP training, and employee feedback to create direct involvement in the quality improvement process. Employees’ ownership of quality in their work can help improve quality across the organization and build an overarching culture of quality. And, to build credibility for a culture of quality, managers and executive leadership should explicitly display commitment to quality to set an example for the organization. In developing a culture of quality through a peer-driven approach, the benefits result in higher quality products and documentation, employee satisfaction, audit success, and a reduction in time and money spent on remediating mistakes.
Trend #2: Digitizing and Integrating Data
Digitization and data integration can leverage technology to advance the quality management process with expanded use of eQMS (electronic Quality Management Systems), while still remaining compliant. This can be achieved by:
- focusing on creating better access to data in structured documents
- using automated workflows for rapid changes and accessibility
- reducing the steps from collecting data to entering it digitally
- monitoring data integrity
Paper-based quality management systems are becoming more and more difficult to use for life sciences companies, with poor accessibility and high risk associated with maintaining a large bulk of files. Paper systems must be managed manually and are inefficient, which makes it difficult to operate with accuracy. eQMS helps a life sciences company keep track of the details using software for automated workflows and electronic signatures, while increasing productivity and compliance. In recent years, medtech companies in particular have been implementing electronic QMS to utilize the cloud capabilities to better control processes. Especially over the course of the COVID-19 pandemic and shift to remote work, this has enabled organizations to operate more efficiently and lessened the impact of changes to supply chains, keeping products more readily available. The automation that an eQMS enables has been key for many life sciences companies throughout the pandemic, and the benefits can last through 2021 and beyond.
Contributions by Courtney Loughran