Metrics That Matter
for Contract Manufacturing

Metrics reign supreme in manufacturing, which means any new technology must be evaluated on its ability to drive measurable, scalable impact to your production operations, product quality, and site performance.

MasterControl has been helping companies ensure product quality and compliance for over 30 years — but often those metrics are about mitigating long-term risk versus driving real-time operational gains. That is until now. MasterControl Manufacturing Excellence delivers the next generation of digital production records to drive immediate improvement to site operations and product quality.

And for Contract Development, Manufacturing and Packaging organisations (CDMOs, CMOs, and CPOs), improving operational flexibility, increasing capacity, shortening lead times and improving product quality is more important than ever as demand and competition for contract services increases.

A leading contract development and 503B facility understands that without quality they have no business. To ensure that every product meets the company’s high standard for quality while maintaining critical delivery schedules, they chose to implement Manufacturing Excellence. With Manufacturing Excellence, they are able to tackle quality at the source – on the production line – and are working toward eliminating 90-100% of data entry errors. By moving from a paper to digital solutions they've accelerated incident resolution and have dramatically reduced 400+ master batch records by leveraging MasterControl's intuitive template builder.

Almac Sciences sought to double their production output, but paper was creating bottlenecks. With MasterControl they were able to reduce the production cycle from months to days. And another customer transitioned from paper to electronic production records to increase employee efficiency by 30%, reducing overall manufacturing costs through digitisation without sacrificing product quality.

Customers that have implemented Manufacturing Excellence‘s digital solution for their batch records, device history records (DHRs), travelers, and routers have seen immediate impacts in key performance areas:

Eliminate Input Errors

The elimination of errors generated during manual, paper-based input is clearly the most immediate impact. Consider how many hours of review are spent tracking down common human errors and data integrity issues while product sits waiting to ship. How much does that cost you? Contract manufacturers and 503B compound pharmaceutical producers regularly see a 90-100% decrease in common data input errors after implementing Manufacturing Excellence.

Reduce Deviations

The ability to reduce deviations is critical to optimising any manufacturing process, but reducing both the total number of deviations and the number of deviations that turn into corrective actions/preventive actions (CAPAs) — that’s a game changer. With MasterControl’s integrated digital production records and quality event analyser — which provides a risk-based approach to assessing a deviation’s potential to turn into a CAPA — customers are able to dramatically reduce the impact of deviations in their production environments, leading to faster run times, and quicker release. Fagron, for example, needed a single source of truth to improve consistency and reduce errors across their global locations, and with Manufacturing Excellence they have seen a 50% reduction in deviation times.

GMP Documentation Review

If you have a manual, paper-based process for executing your batch, design history, traveler, or other type of production records, you know that inaccurate, illegible and incomplete data has a ripple effect across your production environment, and creates time-consuming and costly cycles of review and remediation. With MasterControl’s 100% digital data input, built-in controls, in-process training enforcement, and automated workflow routing, you can dramatically reduce time spent reviewing and correcting documentation. After transitioning to Manufacturing Excellence, Repligen saw a 50% reduction of execution or touch time on manufacturing and decreased quality review time from four hours to one hour.

The faster you can release product and get it shipped, the faster capital flows into your business. And that is where MasterControl’s Manufacturing Excellence excels. With MasterControl automating digital production records, you can implement review by exception, allowing you to simplify and accelerate dispositioning and dramatically reduce lead times. While you only have to review exceptions to process and documentation, the solution’s real-time dashboards also allow you to identify issues creating exceptions and take preventative action before they impact product release. Since implementing Manufacturing Excellence, Wellington Foods has been able to reduce its review period from 10-15 days after production completes down to three days — a 75-80% reduction.

Ultimately, any technology solution for manufacturers must be able to improve overall efficiency and productivity, which often comes down to how well it enables an organisation to optimise its current workforce. This doesn’t mean a reduction in head count, but rather a reallocation of resources from inefficient, revenue-inhibiting activities to efficient, revenue-generating activities.

We have seen customers achieve a 50% reduction in the number of individuals dedicated to management of production record paperwork in the first three months of going live. They have been able to reallocate individuals to production process improvement instead of paperwork, which means more people working to get higher quality products to market faster — that changes everything.