With end-to-end operational optimization, secure an advantage in quality management to produce safe and high-quality products in life sciences and healthcare.
How can life sciences and healthcare manufacturers boost their quality management system (QMS)? They must optimize operations and place quality management front and center by utilizing a cloud-based platform that supports quality planning from start to finish. That way, they can effectively anticipate and overcome quality control and quality assurance challenges.
Leverage cutting-edge digital solutions on an integrated platform to optimize quality management.
“Manufacturers apply quality control to discover defective products after they’ve been manufactured. Only products that conform to specifications are distributed into the market,” explained Guillaume Kerboul, Life Sciences and Healthcare Industry Value Expert Director at Dassault Systèmes.
Kerboul added, “Quality control is different from quality assurance testing, which is carried out during production to prevent product flaws. Both are complementary parts of a quality management plan, yet serve distinct roles with different purposes.”
Optimal quality management requires a systematic approach to both quality control and quality assurance for continuous improvement and innovation in new product development.
It’s not the best strategy to take corrective action only when quality issues occur. Neither is testing all processes and validating every single detail
The advancement of cutting-edge digital technologies represents a significant opportunity for manufacturers to rethink quality management systems and boost risk reduction, particularly in the biopharma and medical device industries. From design to final creation, manufacturers can now push new frontiers in life sciences and healthcare products through:
Smarter quality management requires a risk-based approach to test and validate product quality. Fewer variables are tested but critical factors affecting quality will be tested earlier with enhanced scrutiny
Manufacturers can reduce reliance on physical prototypes and minimize capital risk by virtually testing medical devices and biopharma products to identify safe designs for production and submit virtual models and simulation data for regulatory approval.
By integrating data insights from multiple sources, manufacturers can trace decisions, assess risks for various scenarios, analyze the impacts of changes to quality and predictively develop solutions for early prevention of quality issues.
With platformized PLM, manufacturers can embed quality management into a product’s complete lifecycle for full visibility. They can then utilize a predictive and adaptive manufacturing approach to reduce risks, cut costs and accelerate product innovation
Dassault Systèmes’ 3DEXPERIENCE® platform supports total quality management in life sciences and healthcare. By enabling operational optimization in a unified environment, the platform improves efficiency at every manufacturing stage.
Quality planning with the platform’s QMS software enables manufacturers to establish traceability and accurate product identification. Through the platform’s quality document management industry solution that manages authoring and control of the document lifecycle, quality control staff will be able to drive real-time-quality while complying with regulated quality standards, including:
ISO 9001 for Quality Standard
ISO 13485 (Clause 4) for establishment of a QMS
21 CFR 820 for the Current Good Manufacturing Practice (CGMP)
21 CFR 11 for Electronic Records and Electronic Signatures (ERES)
With the integrated 3DEXPERIENCE platform, life sciences and healthcare manufacturers are better equipped to face new quality management challenges in an environment driven by regulatory scrutiny, increasing complexity and product diversity.
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