Why purpose-built eQMS solutions are critical for life sciences

Kari Miller, sr. director, Product Management, SmartSolve, IQVIA explores why purpose-built QMS technology is necessary for the life science industry, from mitigating risk to maintaining regulatory compliance.

Key insights:

• Horizontal eQMSs are not industry-specific and can leave LS companies vulnerable to rapidly shifting regulations and constantly changing requirements.
• It is essential for LS organisations to utilise an eQMS that is a true SaaS platform, achieving quality and compliance.
• A purpose-built system can help companies manage their equipment assets, recording calibration and maintenance results, including establishing procedures and managing lifecycles.

Few multi-purpose systems contain the attributes needed by life science companies. In this rigorous environment, deploying industry-specific electronic solutions in quality management is critical to ensure compliance and mitigate risk.

Risks of horizontal QMSs

Quality management plays a vital role in life science companies, which includes improving product quality, maintaining a state of control, minimising risk, ensuring patient safety, and helping to maintain regulatory compliance.

However, many LS organisations employ horizontal QMSs that are built to serve other industries as well, such as natural resources and aerospace. This practice leaves a life sciences company vulnerable to rapidly shifting regulations and constantly changing requirements that the non-life science eQMS cannot respond to quickly enough.

The promise of a purpose-built, true SaaS platform

It is essential for life science organisations to identify and make use of an eQMS that is a true SaaS platform. As more companies embrace digital transformation, the use of SaaS programs is increasing, and the global SaaS market is projected to grow more than 21% by 2023. This popularity has led to a market for solutions that don’t qualify as true SaaS platforms and fall short of critical features like agility, security, upgradability and efficiency.

Life science companies can avoid being saddled with this problem by investing in eQMS technology purpose-built for the industry. Doing so allows organisations to perform the functions necessary to achieve quality and compliance, such as:

• Eliminating siloed systems
• Driving harmonisation
• Reducing the overall cost of quality management
• Enabling informed, data-driven decision-making, and
• Promoting regulatory adherence.

Typically, vendors of generic systems don’t focus as much attention on LS research and development, and their R&D priorities and future product roadmaps are very likely headed in multiple directions than life sciences.

Benefits of an eQMS solution

Implementing a next-generation, fit-for-purpose eQMS in an LS environment offers companies several specific benefits. These include:

Facilitating regulatory compliance

An intuitive user experience, combined with automation and process integration tools, identifies relevant regulatory requirements easily and quickly. This allows quality management professionals to streamline the tasks necessary to achieve compliance. It also provides assurance that systems are inspection-ready and meet the toughest industry-specific standards.

Delivering meaningful insights

A data-driven eQMS tailored for the life sciences industry typically offers high-level intelligence and reporting functionalities, which deliver meaningful insights to executives. This empowers decision-makers to make faster, more informed evaluations based on reliable data and take the best actions under any circumstances.

Creating a scalable, flexible solution

Who knows when the world will be faced with another pandemic, or some other health-related catastrophe? The need for scalability and flexibility is a lesson well-learned during COVID-19, and one that LS companies have taken to heart. Being able to rise to a challenge, whether that involves increasing or decreasing the overall company size, diverting resources to specific teams, or adjusting operations to accommodate new ways of working (such as remote), means organisations need tools that support growth, contraction, and restructuring, including virtual enablement.

Improving patient outcomes

Life science companies play a significant—if indirect—role in driving patient outcomes. An agile and efficient organisation that is up to date with regulatory requirements can guide life sciences companies in their decision-making process. This impacts patient treatment pathways and helps to improve patient outcomes. 

Industry-specific solutions offer additional resources

The benefits of a purpose-built eQMS don’t end there, however. When a company implements an appropriate, next-generation solution – that is fully integrated out of the box – its benefits include efficiency, accuracy, a more collaborative environment. Organisations will also benefit from a laundry list of additional features and resources.

• CAPA management features can help organisations to develop a risk-based, streamlined problem resolution process that feeds continuous improvement.
• Document management modules deliver flexible workflows, accelerated document review facilities, interactive dashboards, and customised processes.
• Change management tools enable controlled, rapid, informed decision-making and quick implementation.
• Integrated, intelligent workflows move changes methodically through various stages without the need for separate systems to provide potentially conflicting next-best action engine and generate plans for actioning approved modifications.
• Cloud computing facilities that protect and store data with the highest security protocols and best cost efficiencies.
• Training software that enables enterprise-wide visibility into training gaps, completion, and history.
• Instruction management programs that provide employee certifications, boost productivity, minimise job quality issues, and ensure labor policy compliance.
• Complaints management modules, which streamline the handling and reporting of complaints to facilitate quick responses and improve management oversight. 
• Audit management options that simplify the planning and execution of all types of audits, manage the findings and produce detailed reports.
• Supplier management solutions, which streamline supplier onboarding, incoming inspections, maintain supplier scorecards, integrate with existing business systems, and monitor trends to ensure quality product deliveries.

A purpose-built system can even help companies manage their equipment assets, recording calibration and maintenance results, including establishing procedures and managing lifecycles. Management and remediation of out-of-tolerance and failure events are par for the course. Conducting reverse traceability of standards and quantifying performance are also givens with measurement data entry features that deliver accurate test ratios.

The final analysis

Few generic QMS systems come close to providing the features and benefits needed in a highly regulated environment like life sciences. Industry-specific, fit-for-purpose solutions enable organisations across the LS ecosystem to deploy, extend and integrate their quality management processes as the demands on their systems change with new industry and regulatory developments.