Choosing a quality management system (QMS) is a critical decision, especially in regulated industries like pharmaceuticals, biotechnology, and medical devices. The right QMS can streamline compliance, reduce risk, and improve operational efficiency. The wrong choice can create delays, increase audit exposure, and lead to costly rework.
Before selecting a vendor, ask these 10 questions to ensure their solution fits your needs today and scales with you tomorrow.
1. Is the QMS purpose-built for your industry?
Generic QMS platforms may lack the depth needed for highly regulated environments. Look for vendors with experience in your specific industry. Ask whether their system supports GxP, ISO 13485, 21 CFR Part 11, and other relevant standards out of the box.
2. Is the system cloud-based or on-premises?
Cloud-based QMS solutions offer advantages in accessibility, scalability, updates, and maintenance. On-premise systems often require significant IT resources. Understand the vendor’s deployment model and whether it fits your infrastructure and growth plans.
3. How fast can it be implemented?
Ask about average implementation time and what’s included in the onboarding process. Vendors with pre-configured templates and industry best practices can deploy faster and reduce validation effort. Request a sample implementation timeline based on your organization’s size and needs.
4. What validation support is included?
For life sciences companies, validation is required. Ask if the vendor provides validation documentation (IQ/OQ/PQ), automated validation testing, and ongoing support for re-validation when the system updates. The more prebuilt validation resources, the lower your workload and risk.
5. Does the QMS integrate with existing systems?
A QMS should not operate in a silo. Confirm whether the vendor supports integrations with your ERP, LIMS, MES, or CRM systems. Look for standard APIs, integration support, and proven use cases that demonstrate connectivity.
6. How flexible is the configuration?
Every company has unique processes. Ask what level of configuration is allowed without custom coding. Can you update workflows, forms, and permissions on your own? Systems that require vendor intervention for basic changes can become bottlenecks.
7. What support and training are offered?
Find out what training is available for admins and end users. Ask whether the vendor provides ongoing customer support, response time SLAs, a dedicated account manager, and access to a knowledge base or customer community.
8. What security and compliance certifications does the vendor maintain?
Ask if the vendor is certified with ISO 9001, ISO 27001, and other recognized standards. Confirm they follow best practices for encryption, access control, data retention, and backup. If you’re in a regulated industry, ensure the system is compliant with 21 CFR Part 11 and other relevant regulations.
9. What is the total cost of ownership?
Beyond licensing fees, ask about hidden costs: implementation, validation, training, upgrades, support, or additional modules. A transparent pricing model helps avoid surprises and makes it easier to evaluate ROI.
10. Can the vendor provide references or case studies?
Request customer references from companies similar to yours. Ask how the system performs in real-world use, how responsive the vendor is, and whether the QMS has delivered measurable value. Case studies can give insight into deployment success, user adoption, and long-term outcomes.
Final Note
Choosing a QMS vendor is a decision that requires careful evaluation and clear intent. A reliable, scalable, and compliant system supports your growth, strengthens quality, and simplifies regulatory readiness. Asking the right questions up front helps you avoid risk and ensures the system you select can serve your needs long term.
Looking for more information on choosing the right solution? We’ve created a white paper that guides you through the process.
