Bringing new drugs and therapeutics to market is an expensive and time-consuming process. With so many policies and procedures to track and maintain, many biopharmas use electronic quality management systems (or eQMS) to centrally manage and monitor compliance.
When implemented correctly, a QMS can save you time, prevent headaches, and ensure the finished product meets client demands and manufacturing guidelines. But you shouldn’t rush the process.
With so many QMS platforms to choose from, it’s essential to do your research and consider several factors, including:
- Your specific needs
- The size of your organization
- Regulatory requirements
- Features the platform offers
Making a decision isn’t always easy, even if you’re tech savvy. Thankfully, there are ways to ease the pressure. Partnering with an experienced functional service provider can help you evaluate, implement, and integrate a QMS system, while allowing your core team to stay on task.
Evaluating Quality Management Systems – Key Benefits and Features to Consider
Before you invest in an eQMS, take some time to consider each platform’s benefits and features, including:
- Price. QMS systems are an investment up front, but the peace of mind they provide is invaluable. Without an adequate quality management system in place, you run the risk of fines, investigations, and compliance issues.
- Technical Capabilities / Functionalities. The right quality management system will save you time right out-of-the-box. Make sure the QMS you choose offers core process integrations, such as audits and reporting, compliance and risk management, and document management.
- Integration with Existing Systems. Likewise, select a QMS that can integrate with your existing software and systems. Many of the eQMS programs developed for the pharmaceutical industry merge with Learning Management Systems (LMS) and Trial Master Files (TMF).
- User Experience. QMS platforms are designed to save you time and energy, but some are more intuitive than others. Before committing to a long-term contract, it is important to do your due diligence on the user experience – set up a demo to get a feel for the interface, sign up for a trial if it is available and ask the right questions.
- Customer and Technical Support. Implementing new software typically presents challenges. At one point or another, you’re sure to encounter installation problems, user errors, or other technical glitches. Make sure to partner with an organization that offers reliable and accessible customer support.
Comparing Top Quality Management Systems: Master Control, Qualio, and Veeva Vault
Now that you know some of the key benefits and features to consider, let’s take a closer look at three of the top pharmaceutical eQMS systems.
Master Control is one of the most well-known (and widely used) eQMS systems in the pharmaceutical industry. It has an extensive set of features to help life sciences companies meet compliance requirements and navigate regulations.
- Highly scalable
- Robust platform
- Strong technical and customer support
- Could be cost-prohibitive for smaller organizations
- With so many capabilities, organizations may not need or use all the offerings
Best For: Large Global Enterprises
Consider Master Control if you’re a large, established life sciences business that needs complex and highly configurable software.
Qualio is a cloud-based quality management system that caters to small and medium-sized life sciences organizations.
The program is incredibly user-friendly and ideal for companies wanting to implement a quality management system for the first time. Qualio boasts various features, including document authoring, review, and approval, as well as full audit trails.
- More affordable option
- User-friendly interface that’s easy to use
- Created for startups and growing companies
- Onboarding services are an add on/sold separately
- Doesn’t offer Performance Qualification (PQ) validation
- Not as many features as larger players, like Master Control and Veeva Vault
Best For: Small and medium-sized life sciences companies.
Consider Qualio if your company is in the process of scaling. The software is affordable and incorporates FDA, cGMP, and ISO requirements.
3) Veeva Vault
Veeva Vault is a cloud-based QMS solution, similar to Qualio, but it boasts a more robust set of offerings. The software features built-in “best practice processes” for everything from deviations and complaints to lab investigations and proactive management initiatives.
- Proven track record of success (founded in 2007)
- Designed for easy collaboration with external partners, including contract manufacturers and suppliers
- Integrates with all of Veeva’s additional product offerings
- Secure database
- Suitable for companies of all sizes
- Customer service occurs outside the platform (e.g., there’s no internal ticketing system, so phone or email communication is required.)
- Frequent software updates which may cause disruptions, delays, or headaches
- Some clients report that technical support is lacking
Best For: Medium and large-sized life sciences companies, particularly those already familiar with (or using) Veeva systems.
Need Assistance? A Quality Assurance Service Provider (FSP) Can Help
With so many variables to consider, selecting the right QMS system for your business might seem daunting. A Quality Assurance service provider can make the process easier, by assessing your needs.
After you select a quality management system to implement, a service provider, such as Harbor Clinical, can help:
- Integrate the software with your current systems
- Support you through implementation and training
- Assist with regulatory compliance and risk management
Electronic QMS are amazing tools that play a crucial role in bringing new drugs, devices, and therapeutics to market. But choosing a QMS platform that aligns with your budget, company size, and current goals can seem like a daunting task. A service provider, like Harbor Clinical, can help you select, validate, integrate, and implement the best QMS based on your personalized clinical research needs.