VP Medical Device Practice at Critical Manufacturing
How can a MedTech manufacturer secure its position as a valued partner in the fast-changing healthcare industry? It all comes down to being reliable on many fronts.
Predictive quality can prevent possible defects and can help predict recalls by combining AI, advanced analytics, design, production, supply-chain, and field data.
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.
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.
To meet the strenuous requirements of Current Good Manufacturing Practice, if there were ever an industry segment which needs Industry 4.0 implementation, it would be the pharma industry. Let’s examine how a modern MES is able to help manufacturers in the pharma segment better manage their production and their supply chain to unleash Industry 4.0 benefits.
The urgency of response to Covid-19 and the market whiplash are causing MedTech companies to rethink their product mixes to either innovate or partner with other technology companies to answer the pandemic needs. MES has reinforced its place as a critical component in GMP for these companies.
