The quality experts at InfinityQS recommend five
ways in which medical device and pharmaceutical manufacturers
can use enterprise quality systems, manufacturing intelligence platforms, and automated device integration to decrease recalls, reduce waste, and increase profitability. These technologies work together to speed time to market and streamline regulatory compliance procedures by improving the efficiency of manufacturing processes—using data to understand process variability, standardize facilities after mergers or acquisitions, and better align R&D and engineering.
1. Be preventative—not just responsive.
Because of the speed necessary for life sciences companies to take a new pharmaceutical product or medical device from R&D to market, manufacturers have traditionally focused on production volume and developing comprehensive response plans in the event of a recall. With a quality culture—and a digital manufacturing quality platform in place—engineers, quality professionals, and executives can analyze data and look at the big picture to better understand the inherent variability in their manufacturing processes.
Operators can then make adjustments based on the garnered insights to improve product quality, help prevent recalls, and plan for continuous improvement. Cell- or suite-based production is ideal for compliance; however, a holistic picture of the data collected in these cells can help drive innovation and better mitigate risks.
2. Use electronic acceptance sampling techniques.
Products manufactured for the life sciences industry are often ingested or implanted in the human body. That makes inspection a critical step in the manufacturing journey. A 100% inspection would be expected for both incoming and final inspections. That demands a lot of resources from a typical manufacturer: people, metrology, time, and paperwork.
Instead, the use of Statistical Process Control (SPC
) and acceptance sampling
techniques—Lot Tolerance Percent Defective (LTPD), American National Standards Institute
(ANSI) Z1.4, ANSI Z1.9, or Zero Acceptance Number Sampling (c=0)—are statistically sound and proven methods to reduce inspection frequency while maintaining the highest level of quality.
3. Eliminate paper and manual processes.
The amount of paperwork required to support the development and production of a single product can be overwhelming. Collecting and storing manufacturing data in a digital quality management system eliminates cumbersome binders and filing cabinets, while ensuring that all your data is easily accessible and understandable.
By automating manufacturing processes and data input into a single unified, centralized repository, manufacturers can increase data accuracy and efficacy—and create definitive traceability for every product, component, and ingredient. Extending automation to incoming inspections with device integration saves both time and personnel hours, leading to additional cost savings and efficiencies.
4. Simplify regulatory compliance and validation.
The critical nature of pharmaceuticals and medical devices elicits strict safety regulations on both products and technology. Complying with laws from the Federal Drug Administration (FDA 21 CFR Part 11
and Part 820
), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Q9, ICH Q10
), the International Organization for Standardization (ISO 13485
), or the European Commission's Directorate General for Enterprise and Industry (GMP Annex 20
) can prove to be
challenging—and can cause delays in production.
Utilizing a digital quality management system to access necessary data easily satisfies reporting requirements for each of these organizations. And software that provides validation assistance further speeds up the process.
5. Track and understand scrap and yield.
Life science organizations go into high-volume production soon after products are approved for public distribution. This provides quick remedies for medical ailments, but often results in high levels of scrap. Although manufacturers note scrap and yield, many don’t track these numbers across an extended period—and often don’t understand why the numbers are so high. Digital quality management software—powered by SPC—monitors scrap, and enables you to trace it back to its root cause. Adjusting processes or packaging based on this analysis can decrease the amount of waste and scrap, mitigate costs, and ultimately increase profitability.
Pharmaceutical and medical device manufacturers deliver life-altering, life-saving solutions for a growing number of diseases, disorders, and physical afflictions. The use of technology to employ a holistic approach to product quality management across the value stream can inevitably help ensure product safety and regulatory compliance—while increasing speed to market and corporate profitability. The result is a win-win situation for everyone, from supplier to consumer.
Take advantage of the technology at your fingertips today: Learn more about InfinityQS quality management solutions. Contact one of our account managers (1.800.772.7978 or via our website
) for more information.