Quality Solutions, LLC can assist your pharmacy with USP<797> compliance in a comprehensive and cost-effective manner. Drawing from its validation, certification, cleanroom, and technical services expertise, we can help you gain and maintain a documented state of control over your pharmacy.

Our approach to all USP<797>projects focus on the pharmacy's Quality System or put simply, the documented plan that details how your pharmacy complies with USP<797>.

For Clients that have existing Quality Assurance systems, clients can select from the services below to complement their compliance efforts.

For clients that have not developed and implemented their Quality Assurance System or are looking to evaluate their Quality System and facility, Quality Solutions will first assess the facility & quality system, and as appropriate, make recommendations to strengthen and develop your quality system. Next, QS will execute all necessary testing, certification and personnel competency assessments.

All pharmacies are unique and we focus on customizing our services to your facility. This customized approach coupled with a focus on Quality Assurance planning differentiates us from our competitors.

Therefore, QS offers more than a menu of services, but a Quality Approach to our projects.


Consulting
  • Gap Analysis/Audit
  • Facility Design/Redesign
  • Policies and Procedures
  • Deviation Investigation and Root Cause Analysis
  • Hazardous Drug Assessments

Certification and Testing
  • Certification
  • Equipment Calibration

Environmental Testing and Sampling
  • Environmental Sampling Plan and Testing

Personnel Training and Assessment
  • Testing Protocol Development
  • Staff Training
  • Personnel Competency Assessment

 
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