QUALITY

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CONSULTING SERVICES FOR LIFE SCIENCE ORGANIZATIONS

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THE NEED


Key to regulatory compliance, and also to optimal product and data quality, is an independent Quality Assurance unit. Even in organizations with excellent Quality Control, it is critical to have someone to “check the checkers.”


In addition, Quality Assurance performs a critical role in reviewing procedures and data before the information goes to the FDA. A slogan commonly posted in final assembly or Quality Control areas of factories reads, “The Next Inspector Is Our Customer.” For a development-stage biotech company or for a core lab providing data to support regulatory filings, the “customer” is FDA. It is wise to include a friendly review by contract QA so that errors and deficiencies may be corrected or otherwise addressed before they reach the “customer.”



CONTRACT QA SERVICES


Our contract Quality Assurance services include:




ON-SITE ACTIVITIES


For on-site activtities, typically, the laboratory and the QA consultant will arrange for meetings either on a regular schedule or on an as-needed basis. Frequency of visits will depend on the volume of work and the amount of follow-up required.


Outsourced QA review of laboratory data typically occurs according to the following cycle:


  1. The laboratory performs an activity according to its protocols.
  2. The laboratory staff complete internal review of the documentation.
  3. The QA consultant reviews the data and generates a list of findings.
  4. The laboratory staff address the findings.
  5. The QA consultant reviews the responses to the findings.
  6. Once satisfied


Some activities (document review, for example) can be performed off-site. Others (process observation, for example) usually require a site visit. We will tailor our approach to your needs.


In addition, we make ourselves available to our clients for advice and brainstorming outside the scheduled visits.



OUR APPROACH


Our contract Quality Assurance services are a very cost-effective solution for organizations that have the need for Quality Assurance but do not need a full-time QA professional on staff. Furthermore, our status as an independent organization satisfies the regulatory agencies’ requirement that Quality Assurance report independently to top management.


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CONTRACT QUALITY ASSURANCE

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