OMS
Consulting
Product Lifecycle Management
Looking to automate your engineering, change control, and document control activities. We have been at the forefront of developing world-class PLMs in Oracle Agile, Windchill, Arena Applications, etc.
QMS Solutions
Managing CAPAs, nonconformances, and complaints manually or in cryptic excel files is time-consuming and prone to error. By choosing the right system and leveraging its scalability, one could give employees a system that not only tracks and maintains data but could be used to obtain meaningful root cause and trending data.
Business / QMS Software Validation
Need assistance in developing a validation plan to get your system operational, let us offer you our guidance. By providing you with an appropriate level of test coverage, you’ll have a robust test strategy that provides appropriate risk management and appropriate rationale for sample size, reliability, and confidence. Thus ensuring your system operates well, and is not prone to poor performance.
We started our careers in the industry when both the FDA and Europe started taking a harder look at Design and Development. We offer practical service solutions to your development and remediation efforts.