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GxP Lifeline

Showing items tagged as Change Control

  • 2022-bl-medical-device-change-control_132x132

    Keys to Managing Change Control Effectively in Medical Device Manufacturing

    Change control is a critical capability for medical device manufacturers. But managing change effectively and efficiently is easier said than done. Read on to gain a deeper understanding of the core elements of change control, regulatory expectations for managing changes, and ways your organization can overcome common change-related challenges.

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  • 2021-bl-coda-corp-change-management_132x132

    Change Management and Change Leadership: A Critical Relationship

    Change Management is a term we have all heard and regularly use. Unfortunately, we seem to use it generically, lacking the level of precision which would clearly differentiate between Managing Change and Leading Change.

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  • 2020-bl-change-pharma-mfg_thumb

    Deviation and Change Control in Pharmaceutical Manufacturing

    In pharmaceutical manufacturing environments, strict compliance to approved policies and procedures is essential to keep manufacturing operations in a state of control. Uncontrolled changes like deviations can affect the safety and reliability of products, not to mention the regulatory status of products, directly affecting public health and safety. This is what makes change control – and a paperless system – crucial.

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  • 2019-bl-thumb-respost-cloudly-with-chance-of-awesomness

    How Cloud Migration Has Become More Seamless for Regulated Companies

    Cloud technology has reached a level of maturity where many regulated companies are discovering that operating in the cloud is more cost effective and a competitive advantage. A new white paper discusses the benefits of moving to the cloud and how companies can make the migration process smoother and faster.

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  • 2018-bl-thumb-exploring-nutraceuticals-delivery-options

    Top 5 Nutraceutical Trends in 2018 - Exploring Different Delivery Methods

    The nutraceutical world is constantly evolving to meet consumer needs and the search for alternative delivery forms is a prime example of this. To combat pill fatigue, supplements now come in liquids, powders, lotions and sprays, but companies embracing innovation need to be aware of the challenges they face.

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  • Cleanroom Compliance: How to Address Common Challenges in Document Control

    A recent warning letter to a medical device firm shows the importance of proper documentation of cleanroom maintenance procedures and corresponding control of those documents. The FDA noted the company’s failure to establish and maintain written procedures for avoiding contamination of equipment, as well as the incongruity between some of its cleanroom procedures and records of actual practice (1).

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