Large Company QMS Harmonization

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LARGE COMPANY QMS HARMONIZATION CASE STUDY


CHALLENGE:
One of the world’s largest life science companies was experiencing a significant increase in scrutiny from the FDA. At a time when the FDA’s increased expectations of QMS harmonization within large integrated life science companies had increased, multiple audits highlighted the need for harmonization across the company’s groups.

The company recognized the need to develop a structured QMS hierarchy that provided for harmonization at a global level while maintaining the ability to provide the required controls at the local and product-specific level. Additionally, given the requirement to translate into multiple languages, AlvaMed was asked to edit the standards for clarity and readability.

While the company recruited a major international consulting company to carry out the majority of the project, AlvaMed was recruited for our in-depth knowledge of regulatory compliance, quality systems experience and technical writing expertise.


APPROACH:

AlvaMed contracted a $200,000 year-long project to work with multiple “process teams” to develop global policy standards that provide a way to control and harmonize lower level local procedures. AlvaMed teams provided QMS and regulatory input to the company’s CAPA, Training and Supplier Management policy standards. AlvaMed also reviewed every “final draft” standard and edited documents for clarity and readability. Given our combined expertise in regulatory requirements and technical writing, we were able to successfully revise drafts within a day.


RESULTS:

AlvaMed’s work product was highly regarded by the company’s global quality systems and regulatory leadership.

The global standards remain in effect today and the company has provided the best indication of satisfaction by having AlvaMed continue to support the effort, developing lower level procedures to align with the policy standards.

During the project AlvaMed instigated and developed:

  1. A single global quality system glossary where the definitions were sourced from multiple regulatory authorities across the company’s pharma and medical device industry segments.
  2. Consistent application of terms across the entire set of global policy standards.
  3. A single global procedure and associated template that controlled document format, use of language, grammar and punctuation. 

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