CSV, Inc.

Our Business

Through our extensive experience in the FDA regulated industry, we’ve had the opportunity to gain significant experience in very challenging environments.  These challenges included all aspects from resource management, to process improvement, to quality assurance/compliance, to working towards modifying well entrenched culture to best comply with regulations, as well as to improve overall efficiencies and effectiveness of the IT and Quality departments. 

One of the reasons that we’ve been effective in meeting, understanding and conquering these challenges is our solid experience in all aspects of Quality and IT roles.  These experiences have provided a great insight into many issues that arise within each of these groups and how the other can help mitigate much of these.

Some of the notable experiences include the opportunity to manage and grow fully rounded QA teams as a Director of Quality & Validation services.  In this role, we managed a team of 25 people, including QA Compliance Specialists, Testers, Auditor, and Documentation Specialists (Tech Writers and Training Specialists).  We managed and trained the group on SDLC, plus outsourcing of Quality Assurance and Testing Services.

At another Quality Manager role, we had initiated work to create efficient and effective SDLC policy (from initiation phase to retirement, including maintenance), and helped deliver the training.  The key focus was to help the IT group deliver projects within scope, within budget, and on time.  Once fully implemented, with the SDLC policy,  enabled to reduce the overall project timelines by 75% (from 2 years to within 6 months), cost by about 60% (from $2million to $750k), deviations by over 96% (from over 500 minor to major defects, to 20 minor defects) for a similar scoped project.

Extensive experience determining the level of compliance of respective computerized software systems with the use of Vendor and Internal Audits and Gap Analysis, leading to findings, remediation plans, and CAPAs; manual and automated testing, as well as helping companies move from manual to automation.

Tools expertise consisted of issue/bug tracking, code control, CAPA, testing systems and good traceability matrix.