The approach must integrate the Quality System and Business Processes across the business. We have observed a break down across these business elements which can play a significant role in product realization, merger acquisition, and integrating the business and quality processes to work together efficiently.
A data-centric approach is key to overcoming the increasing regulations and need to reduce costs while innovating and growing is to establish a data-centric approach.
One of the key aspects to overcome the increasing regulations and need to reduce costs while innovating and growing is to establish a data-centric approach. The approach must integrate the Quality System and Business Processes across the business. We have observed a break down across these business elements which can play a significant role in product realization, merger acquisition, and integrating the business and quality processes to work together efficiently.
Life Sciences Information Technology departments are often tasked to deploy and maintain enterprise systems across a global scale to support business requirements. Constantly having to integrate and modify Information Technology systems to support the dynamic needs of the businesses they support can be very challenging and complex. When adding the regulatory requirements to show appropriate control and provide assurance these systems operate as intended, especially when supporting the quality system controls that are automated within the regulated environment, the process becomes even more challenging.
Unfortunately, many organizations start looking at the validation requirements late in the lifecycle of these projects which can increase costs significantly, impact timelines, and put the program and project at risk. Laying down the required strategies and plans to meet the regulatory requirements early in the lifecycle minimizes risk and reduces the cost of the overall project. Often, the integrators are really good at integrating the systems, however, they fail to recognize and understand the regulatory requirements for Computer Systems Validation into the overall program and plans.
Many organizations view Compliance and Computer System Validation for Medical Device, Pharmaceuticals, and Biotechnology companies as a time consuming process that uses up all valuable internal resources for weeks at a time. EngiSystems validation solutions enable Life Sciences companies to keep their internal resources focused on primary responsibilities, while also meeting the rigorous validation standards required by regulatory bodies. We provide comprehensive Computer Systems Validation (CSV) solutions during all stages of a computerized system’s life cycle. We have created solutions which integrate with our clients’ systems to accelerate these objectives and maintain compliance for the organization.
Regulatory Compliance and the greater complexity of deploying and maintaining digital solutions within the Life Sciences Industry are very challenging. EngiSystems has developed new methods and models to address the cost reductions required by market conditions and the complexity of the regulatory requirements that are more demanding. EngiSystems provides customized solutions to support the Strategic and Tactical aspects for Global Information Technology organizations within the Life Sciences Industry. There are three aspects we focus on in delivering solutions that reduce costs and maintain regulatory compliance: Compliance, Optimization, and Knowledge Transfer for our clients.
Our Information Technology Solutions include a range of capabilities. We provide Strategic Level professional support and work on developing strategies to move business processes to a complete data-centric mode. We also assist with the tactical aspects of implementing, maintaining, and validating a compliant state of the systems for use within the regulatory landscape.