Quality Management Services: The 4 Essential Qualifications to Look For

    Do you want to know what holds most young life sciences companies back from rapid growth? It's the false idea that you only have two options when trying to fill quality management responsibilities: training your current inexperienced team or hiring outside talent.

    The first option takes a long time, and the second one is risky, time-consuming, and expensive. You can gain a competitive advantage by going with a third option: outsourcing quality management services to a third party.

    While your competition is slowly learning by trial and error with their existing team or spending too much budget on an expensive hire, you can beat them by bringing in an experienced team to quickly implement quality practices and systems at a fraction of the cost. Opting for outsourced quality management services can help life sciences startups and scale-ups grow fast without quality risks.

    The key to success with this approach is finding the right service provider. We'll show you what to look for.

    What to Look for in a Quality Management Services Provider

    Quality management services providers are professional services firms that offer fully outsourced support for quality management systems and processes. They usually manage clients' quality management on an ongoing basis and aren't necessarily direct alternatives to hiring quality management consultants.

    Before you launch your search, be clear about your goals and needs, and build a solid business case for quality management services. Do you need someone with deep, vertical expertise in one type of quality services, such as regulatory support? Are you looking for a provider who can fully implement your QMS and take over quality once you go live? Not all quality management services offerings are the same.

    Once you’ve established your objectives, you can begin to further qualify providers based on platform mastery, regulatory experience, and track record of quality-driven improvements.

    1. Platform Mastery

    Quality management service providers should generally be clear about platform mastery and experience. Hiring a vendor who knows how to use and optimize your specific quality management system (QMS) software is an obvious requirement. Be very wary of prospective partners who claim vague amounts of experience with many different QMS platforms. You should be even more cautious of quality management providers who work with paper-based systems.

    If your service provider needs to learn how to use your platform, it can delay the time-to-value and defeat the primary goal of outsourcing quality. To mitigate this risk, focus on providers who hold certifications or experience with your specific QMS.

    Our software platform has everything small and growing life sciences companies need to move forward—ease of use, flexibility, and scalability. Learn more about our eQMS here.

    2. Regulatory Expertise

    Biotech, pharma, and medical device companies aren’t the only sectors that outsource quality management services. Service providers can offer support to companies in a variety of quality-driven industries, including food, manufacturing, and aerospace. To avoid compliance hiccups, it’s important to make sure a service provider has expertise with your specific regulatory environment.

    For example, a quality management service for life sciences companies should have deep regulatory experience with FDA CGMP and ISO as a core part of their service offerings.

    If you have global aspirations, it’s valuable to partner with someone who is experienced with regulatory requirements for life sciences products in the EU, APAC, and other target markets. Life sciences standards can vary significantly between markets, and an experienced partner can create the groundwork for global regulatory submissions.

    Regulatory experience can be an enormous competitive advantage. A service provider who lacks regulatory experience is an expensive risk. Verify this experience by asking for client success stories and references to make sure they helped other companies pass the regulations that apply to your firm.

    RELATED READING: How to Enable Quality Controls in Life Sciences Marketing

    3. Implementation Experience

    A provider should have a strong track record of implementing programs at companies that resemble your own, in terms of size, industry, product type, and business goals. Implementation experience matters, but it’s also important to verify the quality of the implementation experience they give their clients.

    • Does a quality service provider have strong case studies?
    • Do they have a guaranteed timeline for implementing QMS software?
    • How quickly did they begin creating quality-driven culture in similar situations?

    A strong prospective quality management vendor will acknowledge the fact that no two life sciences clients are the same and commit to an individualized approach. At the same time, they should have the case studies and references to prove you won’t be a test case for implementation.

    4. A Quality-Driven Approach

    Take the time to understand a vendor’s attitude about quality. Does a quality management service provider simply help their clients get through the FDA and ISO by checking off all the boxes? Or do they view quality as an opportunity for excellence and competitive advantage?

    The right quality management service will understand the value of creating a quality-driven culture. They’ll have the case studies to back up this belief, including proof of instances when they helped clients improve their culture.

    Quality Isn’t Optional

    Quality is an enormous asset to life sciences organizations. Continuously improving your quality benefits your bottom line by helping you take products to market faster and win happy customers. Your quality management service provider shouldn’t ever lose sight of how much quality matters on the road to compliance.