Paddock Laboratories (Minneapolis, USA) selected Infotehna as their system of choice

Paddock Laboratories, world leader in specialty pharmaceuticals in Minneapolis, purchased Infotehna eCTDExpert for the development and management of electronic submissions.   The company established a goal to develop and deliver their first electronic submission in 2010.  To achieve this goal, they were seeking a vendor that supported the development of electronic submissions as well as robust content management.  The company embarked on an exhaustive RFP process seeking vendors that met their stringent qualifications.  To ensure compliance with FDA regulations, they wanted the system to be compliant with 21 CFR Part 11, cGMP and other global regulatory requirements.  Most importantly, they were looking for a system that did not require extensive customization and would ensure rapid deployment.  Also, each vendor was required to demonstrate competence in software validation and verification.  9 qualified vendors responded to Paddock and after their search, they selected Infotehna as their system of choice.  The system will be deployed initially by Regulatory Affairs but will soon expand to Quality Assurance, Manufacturing, and other areas as their Global document management solution.  Paddock Laboratories has over 250 people worldwide.