Process design is central to chemical engineering. Mivado GlobalPerformance Solutions team provides design and engineering support for all bio-pharma engineering, and manufacturing projects, addressing pre-conceptual design, conceptual design, basic design, and detailed design.
Process development begins with selecting the optimal process and enabling technologies during product design and proceeds through each stage of development, including scale-up from bench and pilot scale through to commercial manufacture under cGMP conditions.

Validation 4.0 transforms the way the validation is traditionally performed. Applying Validation 4.0 (Validation by Design) will require to adopt a new way of thinking and working as the system requirements should be verified during it development, configuration and implementation.

Periodic Review is a key program of quality system that helps ensure compliance. It is used to verify that validated systems remain compliant with the appropriate quality and safety regulations as well as ensuring that the validated systems remain fit for their intended use.

A systematic, independent and documented process for obtaining and objectively evaluating evidence to determine the extent to which audit criteria are met. The goal is to confirm that the quality system of your supplier is in place and effective to guarantee the quality of services and products.

Mastering and controlling GxP data is essential to ensure that data obtained through GxP activities are complete, consistent and precise and thus guarantee decision-making by pharmaceutical industries and laboratories; and the competent authorities.
MIVADO GP can assist all customers during their project design and development phases. We help you achieving your goals and objectives with respect to GxP. Consultants from MIVADO GP are experts in Industry 4.0, as well as in facility commissioning, qualification and validation. We are also specialized in Lean Six Sigma for continued process improvement.