Quality Management

Medical Device and Pharmaceutical Manufacturing Operational Audits

LexaMed’s concept of quality systems involves the synchronization of procedures and processes thus yielding a quality product. This approach allows us to ensure your compliance with cGMP or ISO requirements. LexaMed can build a robust quality system encompassing all of the necessary elements to ensure it is in a state of constant control. LexaMed has proven expertise in the following quality areas:

Quality System:

Effective controls and monitoring tools
Integrated Systems
CAPA Systems
Deviation and Product Complaint Management Systems
Design Control
Management Review
Supplier Approval Program and Audits

Laboratory Control System:

Laboratory Investigations
SOPs and Test Method Generation
CAPA Plans
Stability Program
IQ / OQ / PQ
Specification Generation

Production System:

Equipment Validation and Qualification
Process Controls
Cleaning Validation

Facilities & Equipment System:

Critical Utilities System Qualification
Validation of Compressed Air and Gases
Clean Room Qualification
Sterilization Processes

Services

Author SOPs and Test Methods
Change Control Management
Compliant System
Risk-based Validation Plan
Data Trending
Testing Execution
Technical Transfer Assistance
Employee Training
Project Management

Benefits

Improved Efficiency
Tailored to Customer Needs
Drive Down Costs
Adherence to FDA and Other Regulatory Agency Compliance
Allows Redeployment of Internal Resources
Quality Compliance

If you would like to discuss your project with one of our experts, please fill out our contact form, and we will be with you immediately.

Quality Management