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Issue 5 2019

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article

Data integrity by design

13 November 2019 | By

The PI System serves as a single source of truth for all operational data, enabling pharmaceutical companies to design the right supply chain to meet business goals.

article

ICH Q12: Technical and regulatory considerations for pharmaceutical product lifecycle management

11 November 2019 | By

The International Conference on Harmonisation (ICH) is drafting guidance for product lifecycle management (ICH Q12) – currently stage 2b, which requires application of the concepts of Quality by Design (QbD) to ongoing lifecycle management and change control. Dave Elder dissects the guidance and discusses considerations for industry professionals.

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Quality control solutions that fuel confident decisions

7 November 2019 | By

As the partner of choice for managing microbial quality control, Charles River’s products and services facilitate confident and objective decision-making, ensuring the integrity of your microbial data, reducing risk, building efficiency and improving your bottom line, while assisting in the journey to bring products to market.