A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences

This eBook dives deep into life science challenges and how leading organizations are approaching them. Specifically, it addresses:

  • How rising world populations and standards of living are increasing spending on healthcare.
  • Pressure of cGMP regulations from FDA and other regulatory bodies.
  • Organizations for approaching quality holistically rather than “as a department”.
  • Real-world examples of leading life science companies’ responses to regulation issues.
  • Benchmark data on how EQMS and MOM applications correlate to improvements in On-Tim Complete Shipments (OTCS), New Production Introduction (NPI), and Products in Compliance (PiC).
  • Recommended actions.

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How Effective Training Management Can Help You Prevent Quality Issues

It’s not enough to have your quality standards on paper. You have to implement and integrate them into your daily operations and prove to regulators that your standards and policies work. “Effective training should be a fundamental part of a company’s quality management strategy as it can help prevent many quality problems from ever occurring,” said Hunter.

In a regulated environment, training is a means to minimize (if not avoid) human error, a common cause of deviations and nonconformances. It’s no wonder that various standards and regulations, such as the following, require training as an integral part of the quality management system.

  • FDA 21 CFR Part 211.25 for pharmaceutical companies
  • FDA 21 CFR Part 820.25 for medical device manufacturers
  • ISO 9000 2000 for general manufacturers and other businesses
  • ISO 13485 for medical device manufacturers

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Product Change Management

Often small to medium-sized businesses make do with the tools they have to manage their product data. Paper, spreadsheets and email are often used throughout the product development and engineering change management processes. These tools can wreak hav…

Blast Motion Case Study

In this case study you’ll learn why Blast Motion turned to Arena BOMControl’s centralized cloud-based solution to facilitated synchronization across the company’s global supply chain team. In addition, you’ll discover how Arena provided the following b…

Turn Disruptive Changes Into High Tech’s Next Big Thing

New advancements in battery technology are having a disruptive impact on product design in the dynamic consumer electronics sector.

It’s a domino effect. When a change to a component occurs there’s a rapid engineering effort to incorporate, source and purchase the component. Manufacturing line/tooling, cut-ins, as well as the production floor are impacted and then there’s dealing with scrap and rework, marketing and servicing.

Companies without the vision and solution to respond to change and adopt new technologies quickly could lose in this competitive fast-paced high tech market.

Discover how Arena PLM helps product companies shift product direction quickly to turn today’s disruptive changes into tomorrow’s “Next Big Thing”.

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Next Generation Collaboration

Social tools, such as Facebook and Twitter, now trump email as the primary means of collaboration in the consumer world. Similarly, enterprises are now looking to harness the power of social media tools to improve business results.Social collaboration …