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Laboratories

 

Pharmaceutical laboratories drive the creation of new drugs and new cures. In order to ensure the accuracy of the results and meet regulatory requirements such as the FDA’s Good Laboratory Practice (GLP) laboratories must implement and maintain a proper quality management system (QMS).

 

Analytical instrument qualification (AIQ) and computerized systems validation are some of the most tedious and time consuming efforts that have to be undertaken to ensure compliance. Manual or paper based systems require tedious work to create documents, maintain them compliant and up-to-date.

 

Clarmon’s solutions automate repetitive processes, enabling users without deep regulatory knowledge to create consistent documents. Fully electronic validation drastically reduces the time needed to deploy computerized systems such as a CDS or LIMS. By electronically synchronizing documents and regulations and instantly revealing change impact, document updates become easier to manage.

 

 

Clarmon’s solutions help Laboratories:

 

  1. Implement and maintain a proper quality management system QMS
  2. Drastically reduce the time and effort needed to manage validation
  3. Reduce the need for outside consultants and implement a consistent approach or policy
  4. Eliminate repetitive documentation processes and reduce the need for outside consultancy (enable users without deep regulatory knowledge to produce and maintain consistent documents via a simple Web and Word based interface)
  5. Synchronize documents and regulations, automatically generate traceability matrices and change impact thus reducing the time and effort needed to manage updates.

 

 

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