Validate. Meet Regulatory Requirements.
Data Intensity works with clients to understand the functional and quality specifications that are important to our customers.
The concepts of validation must be incorporated during the design phase. Our experience in the biotech, pharmaceutical and medical device industries allows us to provide broad system reviews encompassing not only validation concerns, but also long term control, current technology, cost/benefits, ease of maintenance and ability to meet regulatory requirements.
We work closely with our clients to develop VPP (Validation Project Plans) that meet the (VMP) Validation Master Plan parameters that govern enterprise systems. In the event that clients have not settled on how to handle validation within the scope of their VMP, Data Intensity will work with them to develop the infrastructure, providing guidance and thought leadership.
We have experience specifying and qualifying systems according to Good Automation Manufacturing Practices (GAMP4 and GAMP5,) as well as using risk-based approaches to initial validation and change control that follow FDA and ICH standards, with special attention to ICH Q9 guidelines regarding risk assessment. Once a validated state is achieved, we can provide the tools to ensure that operations are performed within the validated parameters and that equipment/systems are maintained and remain operating properly.
Our team has installed and validated enterprise solutions such as the Oracle E-Business Suite, document management systems such as MS SharePoint, vendor audit solutions, distribution control systems, as well as many other enterprise and point solutions.