About US
Our experts have been working and providing validation services to regulated industries during the past 20 years. We are committed to validate your computerized systems in compliance with Current FDA 21 CFR Part 11 regulations and ISPE GAMP 5 Guidelines.
Our History
Our personnel has been providing services to the most recognized Companies for the past two decades. Satisfied clients includes: Johnson & Johnson, Merck, GSK, Watson Pharma, BBraun, McNeil, Bristol Myers Squibb, Pfizer within others.
Our Vision
To be the #1 CSV provider worldwide to support our clients to successfully complete their projects On-time in compliance with regulatory authorities. Our clients processes improvement is our goal!
Our Services
Automation
Validation of high speed automated equipment using latest Software Live Cycle. We start from URS and Validation Plan up to Summary Reports. We continue with the Process Validation. All activities and documentation are performed using the latest’s risk based methodologies and cGMPs’.
Software and IoT Applications
We use modern technologies to expand and improve your manufacturing capabilities. With the use of Internet of Things (IoT) functions we can design and create computer and smart phones applications to get connected with your manufacturing processes from anywhere in the world. We support customized SaMD solutions.
CSV Quality Systems
Are your CSV procedures updated?
CSV is regulated by 21 CFR Part 11. We follow the latest GAMP 5 guidelines! From a new development or updating your actuals CSV procedures, we can create a robust Quality System to assure that all your Computerized Systems remains in compliance.