Quality Management System (QMS) software with features to support quality workflows can have a direct impact on the bottom line at life science organizations.
60% of clinical trials result in a substantial global amendment, which can cost an average of $100,000 to $500,000. Half of global amendments are avoidable with better alignment, processes, and systems.
The wrong QMS software can be a liability to your life sciences company. The wrong system can complicate processes, which leads to delays in bringing products to market. Errors can result in for-cause audits and expensive rework. But the right software can be an asset which saves money and gives your firm a competitive advantage. With the right features, companies can avoid amendments, non-conformances, and failed certifications while taking big steps forward in efficiency, speed, consistency, and cost savings.
In this post, you'll learn which features matter most to drive substantial quality improvement in the life sciences industry.
The QMS Software Features Life Science Companies Can't Survive Without
QMS software should offer a centralized, cloud-based system which helps organizations achieve goals of innovation, quality, and compliance. The features should eliminate the negative consequences that accompany poorly designed systems, such as excessive emails or unhappy employees. A sub-par software's impact on processes and people can also lead to much more substantial risks, including but not limited to, an FDA audit or the need to apply CAPA processes.
A system that is easily configurable in ways that do not require programming support or revalidation is ideal for the small or mid-sized life sciences company. This enables a lean quality team to quickly build out and implement electronic processes as the company grows and scales.
7 QMS Software Features to Help You Save and Grow
QMS software is the core of a life science's organizations quality activities. The features should support effective global collaboration and compliance at each stage of the product lifecycle. To remain competitive in an evolving market landscape, QMS features should facilitate a quality-driven culture and create transparency.
1. ISO / FDA quality system
An FDA quality system is necessary for the manufacture and sale of devices, drugs and biologics in the U.S., while ISO certification and compliance is necessary for distribution to non-US markets. The penalties for a system which fails to meet requirements are significant. The FDA has delivered violations against organizations with outdated systems and standard operating procedures for data handling, which can include costly penalties and product recalls.
A QMS for life sciences has to offer quality systems which reduce ISO and FDA red flag risks. However, to deliver real value and save rework, it should also make it easy for your organization to comply and be in a constant audit-ready state.
Evaluate how easily the software guides you through the process to meet requirements:
- Does it offer templates with all necessary information blocks?
- Does it smooth operations with automated reminders?
- Does it group necessary documents for compliance?
- Is it simple and intuitive to use?
Simplified workflows are a necessity to avoid the risks associated with not meeting standards or regulations.
2. Real-time, web-based collaboration features
Poor processes can have a surprisingly big impact on collaboration, and in turn, profitability. Inefficiencies cost many organizations 20-30% of total profitability each year due to lost information, miscommunications, or other factors.
A missing signature or delayed approval can cause big headaches for life science companies. Life science organizations have a critical need for real-time, web-based collaboration features because of complex compliance requirements and workflows.
The QMS can save time and money by simplifying global collaboration, regardless of an individual's location. It can improve real-time performance with automated notifications and rich features for edits and comments on documents.
3. Automated quality management workflows
The software must offer automated quality workflows for monitoring quality, complaints, and CAPA to avoid the risks of non-compliance with FDA and ISO. This feature can also generate value for life sciences organizations if it acts as a tool for transparency across all processes.
Electronic systems provide visibility into measures of quality in ways that are impossible with paper systems. The best QMS software providers offer the opportunity to become a quality-driven organization by linking quality processes and offering closed-loop metrics to eliminate sources of waste and risk.
4. Real-time risk management
Cloud-based software can enable life sciences organizations to take a proactive approach to risk management throughout the product lifecycle. With features to see quality trends in real-time, life sciences organizations can take immediate steps to identify and mitigate potential issues throughout the development and manufacturing phases. Real-time decision making saves time, money and wasted resources by identifying risks quickly before they become real problems.
5. End-to-End Performance reporting
Your QMS software should offer end-to-end performance reporting across people, process, and the entire product lifecycle. When simple dashboards reveal the real-time health of audits, suppliers, employee training, and documents, it's easy to gain a centralized view of the entire organization. Real-time intelligence across all systems was previously impossible with both paper systems and most legacy software approaches.
Life science organizations are facing more pressure than ever before to innovate quickly and become quality-driven. Centralized performance reporting can deliver a competitive advantage in challenging market conditions.
6. Integrated change management
Life science companies need adaptable, real-time solutions for change management to achieve agility throughout the product development lifecycle. An effective change management system is fully integrated with the QMS software to create automation and flexible workflows. The integration of change management with quality management is particularly advantageous to life sciences organizations, due to complex workflows and the vast quality ecosystem.
By integrating change with quality, leaders can perform data-driven changes accordingly.
7. A Seamless link between processes
Software which provides a seamless link between processes, documents, and policies aren't just a way to consolidate workflows. It turns an electronic system into a living model of the organization to enable measurable improvement. Life sciences organizations can benefit from an understanding of the product ecosystem and make iterative, quality-driven changes.
QMS PROVIDER CONSIDERATIONS
The types of features offered in a QMS software matter, as well as the depth and interoperability of systems. In addition to these factors, the software can also have an impact on experience.
A QMS software vendor's approach to helping customers adopt and succeed with solutions should inform your company's decision.
CONSIDERATION #1: EASE-OF-USE
To maintain organizational agility, the QMS platform should be easily configurable. Ensure providers offer options for lean improvement teams to customize without a need for programming or revalidation activities.
We can't stress this consideration enough. Every member of your team needs to be comfortable using the QMS. Think in terms of the lowest common denominator. Will your least tech-savvy team member be able to master it?
Consideration #2: Training
Evaluate whether a software company has the training options available to accommodate your organization's needs, whether you're pursuing a first-time QMS implementation or looking for guidance around regulatory processes. Role-based training can be key to helping life science employees with quality assurance, regulatory, and audit functions succeed with the new system.
Consideration #3: Accessible Pricing
Much like other measures of quality, affordability is highly subjective and can vary significantly depending on a life science organization's size and stage. Affordable for a startup is far different than pricing which is accessible to a mid-sized mature organization. The software should fit your budget and needs. If your organization is scaling up, pricing should offer extensibility and options to outsource functions such as QA to the vendor's services team.
Is your existing quality management software (QMS) driving improvements at your life sciences organization? Get your quality score today. This short, insight-filled quiz can reveal opportunities for improvement based on risks and quality best practices.