What is medical validation?

2020-08-04T17:46:46+00:00December 27th, 2018|

Validation is documented proof which provides a high degree of assurance that a system, process, equipment, manufacturing process, and/or medical device software will be properly installed, operated and processed, is robust, consistent, and delivers a result that meets the predefined qualifications and quality requirements. The purpose of validation is to ensure that the medical equipment meets all quality, efficacy and safety requirements defined for the final product, both in worst-case situations and during all stages of production, while adhering to a controlled and documented process.

To the article What is validation? Why should validation be done? Who is committed to performing validation? What are the types of validation?

Product Development, Delivery System & Clinical Trials

Novel cannabis products and delivery system for improved bio-availability, accuracy, consistency and efficacy that can be proven and backed up with a strong IP and clinical trials

Growing, Manufacturing & Lab Facilities Design

Conceptual & detailed design including personnel/material flow diagram, pressure cascade, cleanness level, utilities and technology based on current GxP standards and common practices

Quality Assurance & Good Practices (GxP)

An effective quality management system establishment, policies and SOPs writing, cultivation and manufacturing procedures, protocols and employees training

Cultivation & Product Manufacturing Technology

Utilities, systems, machinery and controls required for cultivation, development and manufacturing processes that will enable high quality, control and cost-effectiveness.

New Product Regulations & Submissions

Cannabis products specifications and regulatory requirements completion including all relevant documentation and data in order to be submitted and sold in regulatory markets

Qualification &Validation

New facility, infrastructure, utilities, system, machinery, software, control system, manufacturing/cleaning processes qualification and validation protocols, execution and reports

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