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Today, we will examine the role a modern MES with e-DHR functionality can play in not only meeting the record keeping needs placed by regulatory authorities or other bodies, but also in helping reducing cost and effort related to the whole quality assurance and compliance activity. Benefits include the containment and correction of detected errors, reduction of ‘just in case’ inventory and overall product cycle time, and faster response to changing market needs and trends.
With a flawed traditional quality management system, not suitable for Industry 4.0, medical device manufacturers need to look towards the future. Predictive quality is a risk-based approach, where quality is embedded in the DNA of the process and product.
Healthcare is an industry that is almost recession-proof. Throughout the Covid pandemic, healthcare has shown strong resiliency and growth, with an industry value of over $10 trillion by 2022.
While some industries, such as non-essential goods, were brought to a complete halt, other industries supplying goods to battle the disease (the Pharmaceutical, Clinical Diagnostic and Medical Device sectors), were expected to scale rapidly to meet the global demand for their products.
What is the right MES for MedTech digital transformation? Looking at the structure of manufacturing in MedTech—normally multi-site, multi-plant with complex supply chains, it is not a simple answer. How does one implement an MES across multiple manufacturing plants, separated not just geographically but perhaps by operational style, IT infrastructure, work culture, and process technology?
The Automated Validation approach is crucial in helping companies to reduce the time and cost of their validation efforts by at least 60-70%.
As the medical device industry grows despite the pandemic (current research shows a 7% market growth) the need for an MES for process oversight and guidance becomes an even stronger argument.
The CSA ‘represents a step-change in computer system validation, placing critical thinking at the center of the CSV process, as opposed to a traditional ‘one size fits all’ approach.’ CSA helps manufacturers achieve CSV.
Let’s examine a use case of MES implementation where there is a high level of vertical integration, multiple product variants, and production lines executing a mix of process and discrete manufacturing modes. There are also strict compliance requirements with paper-based capture of process data. Essentially, the MES is crucial to the manufacturing process and the value chain.