The pandemic changed the pace of innovation in the life sciences sector forever. Now, quality management processes need to keep pace.
In the “new normal,” speed matters more than ever. We saw “Operation Warp Speed” produce a novel vaccine in record time, demonstrating the life-saving promise of accelerated research and development. As the FDA continues to work toward faster approval pathways, life sciences companies—and the labs that support them—need to double down on lessons learned during the pandemic to get life-saving innovations to market even sooner.
Alongside this record-breaking progress, the pandemic also highlighted the critical importance of agile quality management. Now, as labs continue to decentralize processes, it’s more important than ever to leave paper-based quality management behind. Paper-based processes increase risk, slow incident response time, and limit productivity. Put simply: Paper doesn’t scale, and it opens up a lab team to a host of potential time-intensive and costly issues.
That’s why lab managers are now turning to electronic quality management systems (eQMS). Nearly half of life science quality professionals have already implemented eQMS, based on data from a 2022 industry report. Another 31 percent plan to go digital this year to preserve quality and carry the momentum of the pandemic forward. But for an industry built on paper, the transition isn’t always straightforward.
Here are three key dos and don’ts for digitizing quality management:
1. DO: Look for an eQMS tool that integrates with laboratory information management systems (LIMS).
Many labs already have LIMS platforms in place but still rely on paper-based standard operating procedures (SOPs). This is because LIMS tools, while essential in the lab, often don’t do quality management well. Finding an eQMS that plays well with existing LIMS tools can help improve compliance and drive efficiency from lab bench to product release. If you are considering the transition to an eQMS, be sure to ask potential eQMS partners about their integration capabilities, including customer proof points that reinforce their experience working with other labs to drive smart, effective integrations between LIMS and eQMS.
2. DON’T: Automate only what already exists.
The transition to eQMS is an opportunity to rethink processes and roles, especially that of the lab manager. The role of lab manager should be to define what good quality management looks like and then oversee implementation by detail-oriented, process-minded team members. One of the biggest mistakes labs can make is taking cumbersome quality management processes and simply putting those same exact processes online. That’s a huge waste of time and money. The better option for lab managers is to use the transition from paper to eQMS to rethink your process from start to finish and look for areas where automation and/or new approaches to collaboration can drive efficiencies for both customers and lab teams.
3. DO: Embrace newfound flexibility for your lab team.
Lab technicians didn’t have the same flexibility to work from home during the pandemic as employees in other industries. Still, labs are increasingly transitioning to virtual processes where possible based on the demand for flexibility from employees and potential talent—and due to lessons learned from the pandemic. Technology such as eQMS platforms can help make this possible, enabling lab technicians to document work and streamline administrative processes while working from home.
An eQMS platform can also help lab managers expedite training of current and incoming lab staff—regardless of location. There’s no need to chase signatures. Now, staff can read and understand lab protocols and demonstrate proficiency all in one place—and they can do so anywhere and anytime.
One recent example of a lab that made the transition from paper-based quality management to eQMS is an international molecular diagnostic testing company. They were developing rapid PCR tests for infectious diseases in animals when the pandemic hit. The founders quickly pivoted to apply their technology to the health crisis, developing two test kits to detect the SARS-CoV-2 virus in humans. But they needed an intuitive tool to streamline documentation and get audit-ready. They turned to an eQMS to rapidly transition their paper-based processes and improve training, compliance, and documentation. Digitizing quality management helped this company successfully meet the necessary regulatory requirements to bring their tests to market at the height of the pandemic.
Quality management gone wrong in the lab can be overly prescriptive, down to the color of ink used to log information. But done right, eQMS today can lay the foundation for greater collaboration, speed, and innovation in your lab.