QUALITY CONTROL & COMPLIANCE
With years of industry experience, the team at Endeavor is able to bring a broad and unique set of capabilities to bear in working with Life Sciences companies to improve the quality control process of their business operations. Quality isn’t static — internal and external factors continuously force companies to evolve and improve. Our specialized supply chain strategy consultants are here to help your organization adapt to those changes by supplementing your team and supporting your business in order to achieve better compliance at reduced costs.
KEY COMPETENCIES
Improving Quality Processes and Systems
Applying Lean & Six Sigma to streamline processes and adapt to changing regulatory requirements.
Simplifying SOPs to increase clarity and reduce the burden of training and maintenance.
Deploying quality IT systems, from design to configuration, integration to validation.
Assessment and improvement of your company’s quality management systems and ability to adapt to change over periods of growth.
Inspection readiness training, to prepare companies to avoid, address, and respond to inspection observations.
Quality Support
Our ASQ certified auditors assist in supplier and internal audits and provide support on resolving any uncovered issues.
For computer systems validation, we support all SDLC components and are fluent in both waterfall and agile methodologies.
Expert consultants support creation of new or revised CMC and submission documentation for life sciences companies.
Our GCP compliance team supports quality functions for clinical studies.
We can provide consultants to help conduct thorough investigations to prevent CAPA, NCR, deviations, and change control issues.
