Large company QMS Harmonization Case Study

QMS-Compliance
CHALLENGE:
One of the world’s largest life science companies was experiencing a significant increase in scrutiny by FDA. Also at a time when FDA’s increased expectations of QMS harmonization within large integrated life science companies, multiple audits where highlighting the need for harmonization across of the company’s groups.

The company recognized the need to develop a structured QMS hierarchy that provided for harminzation 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 policy standards that provided the global requirements to control and harmonization to drive lower level local procedures. AlvaMed teams provided QMS and regulatory input to the CAPA, Training and Supplier management policy standards. AlvaMed also reviewed every “final draft” standard and edited the document for clarity and readability. Given our combines expertise of 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 global quality systems and regulatory leadership.

The standards remain in effect today and the company has provided the best indication of satisfaction by having AlvaMed continue to support the effort by 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 pharma and device industry segments.
  2. Drove the consistent application of the terms across the entire set of policy standards
  3. A single global procedure and associated template that controlled:
  4. Document format
  5. Use of language
  6. Grammar and punctuation