Since life science quality and validation projects can vary widely in scope and complexity, each specific project needs to be evaluated in order to determine the resources and technical disciplines appropriate for anticipated tasks.
Highly trained specialists in the areas of regulatory, quality, IT, engineering and others, are relied upon to plan, implement, and monitor qualification and/or validation activities in highly regulated industries, such as pharmaceutical and medical device manufacturing. These projects and programmes may include activities like writing and executing CQV and CSV protocols; ensuring documentation, SOPs, laboratory, manufacturing and packaging operations are robust; creating and running test scripts; analysing existing processes for improvement opportunities; and auditing the documentation trail for compliance. The processes behind these activities must demonstrate that they lead to a consistent, high-quality product, and are central to producing safe and effective products in a fully compliant state. This article describes critical steps an organisation can follow to ensure Commissioning, Qualification and Validation (CQV) and Computer Software Assurance (CSA) programme success every time. Forming the right team and staffing model from the get-go with the right skillset is critical before the project even initiates.
Creating a Multi-Disciplinary Team of Specialists
The practice of using multi-disciplinary teams to support the qualification and validation of new or modified systems, facilities, and processes has become an expectation of the FDA as well as many other regulatory agencies in ICH markets. In addition to drafting and executing protocols, effective quality and validation teams also ensure that any changes made to systems, equipment or processes do not result in compliance gaps.
Finding, evaluating, and securing the right talent for a specific validation project can be a challenge. However, the following types of expertise should be evaluated to help you get the right team established from the project start. Oftentimes, organisations look to specialised consulting and staffing companies with the required level of expertise to fulfil their needs. Sometimes they even outsource the entire validation and quality effort to focus on other high priority projects. A winning formula would be for organisations to ensure they are properly staffed at the right time and can flex to meet changing resource requirements.
