Intelligent Quality is an approach that is rooted in the digital transformation we’ve seen across all lines of business over the past two decades. Complex, modern organizations have tools available in their ‘back office’ that offer data analytics and valuable insights to company leaders - enabling them to make more informed decisions about their business strategy and improve their quality culture. Advancements in CRM and ERP software give quality and compliance teams no reason to continue using stone-age tools.
What quality leaders need to make a true impact on their business is Intelligent Quality. They need access to that digital data at their fingertips and an understanding of how they’re meeting compliance requirements and responsibilities. They need the ability to document and make data readily available anytime and any place - during an audit, for instance.
The reality is that many life sciences companies are still leveraging manual quality management systems. There's an old belief that digital quality is only available to ‘resource rich’ companies, and/or only attainable once a company reaches a certain size. This is no longer true. Thanks to the advent of Software-as-a-Service and cloud computing technologies, Intelligent Quality is accessible to companies of all sizes and stages of maturity.
Instead of, "When can I afford a digital solution?" Quality leaders can ask, "Which one should I choose?"
When I advise those in the process of selecting technology solutions to manage quality for their organization, my first recommendation is for them to select a solution that will grow and scale with their business. As they move through the regulatory phases toward commercialization and/or acquire additional sites or companies, their quality requirements will inevitably change and expand. I find that companies are often short sighted with regards to their future needs, such as managing documents and training across geographic regions and providing different SOPs for specific sites and locations. Implementing a scalable solution now will alleviate these issues down the road.
My second piece of advice for companies to keep in mind when selecting a quality solution is to consider the regulatory endpoint they are trying to meet. It doesn’t help to buy a digital solution that manages documents today if it can't also support electronic signatures that are going to be required for a regulation in the near future.
The third factor to consider when selecting a quality solution is whether or not it is a fully validated solution. There are many technology solutions available in the marketplace today that offer the features and functionality needed to manage quality and compliance. However, if they are not fully validated to meet the unique needs of regulated companies, there will be significant additional time and costs required.
Is your business ready for intelligent quality? Find out how ZenQMS can help.
