Quality Control Laboratories
& QC Labs Operational Readiness
EMPQ
-
Disinfectant Efficacy Test (DET)
-
EM Baseline Study
-
Risk Assessment
-
Contamination Control Strategy
-
SOPs: Gowning, Cleaning/ Disinfectant, EM Program
Our experienced Biopharma Subject Matter Experts lead in the execution of our proven customized EMPQ Protocol to meet our clients’ MFG Facility requirements. We have established the following EMPQ Readiness activities to support the qualification of the MFG Facility to support product quality.
Analytical Methods
-
Disinfectant Efficacy Test (DET)
-
EM Baseline Study
-
Risk Assessment
-
Contamination Control Strategy
-
SOPs: Gowning, Cleaning/ Disinfectant, EM Program
Product Characterization
-
Product Characterization
-
Development of Analytical Control Strategies
Count on our expertise for accurate solutions. Take advantage of customized services in analytical method development, testing, transfer, qualification, validation, product characterization, and LIMS implementation.
Implementation
-
LIMS Implmentation
Our company specializes in LIMS implementation, providing tailored solutions to meet your laboratory's unique needs. We begin with a thorough assessment of your current workflows to identify areas for improvement. Our team will customize the LIMS software and offer comprehensive training to ensure your staff is well-equipped to use the system effectively. With our support, you can enhance data management, boost efficiency, and achieve compliance seamlessly.
Quality Assurance
Our QA experts have experience in the field and as the client. These SMEs provide sound guidance based on best practices and all applicable regulations/ guidance.