QUALITY SYSTEMS

Interested in seeing what we can do for you? Call or email us to start the conversation.

Assess, develop, implement and apply continuous improvement to quality systems.
Author policies & procedures, design, author, review, revise of master batch/production records.
Document control tools.
Develop and implement investigation/deviation management system.
Perform and assess product quality investigation.
Implement risk management program/validation and qualification program.
Training programs.
Develop and implement batch data release tracker.
Establish quarterly metrics and management review.
Author standard operating procedures (SOP) for all areas supporting GXP activities.

Assess and implement phase appropriate GXP Quality Systems using Discover, Analyze, Strategize and Implement approaches

(Environmental Monitoring Performance Qualification)

Assess, develop, implement and apply continuous improvement to Quality Systems.
Author Policies & Procedures, design, author, review, revise of Master Batch/production Records.
Document Control Tools.
Develop and implement investigation/deviation management system.
Perform and assess product quality investigation.
Implement risk management program/validation and qualification program.
Training programs.
Develop and implement batch data release tracker.
Establish quarterly metrics and management review.
Author SOP for all areas supporting GXP activities.

Assess and implement phase appropriate GXP Quality Systems using Discover, Analyze, Strategize and Implement approaches