Validating AI and ML Integration in LIMS and ELN: A Comprehensive Approach with GMLP, GAMP and USP <1058>.

The integration of Artificial Intelligence (AI) and Machine Learning (ML) in Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN) has the potential to revolutionise laboratory operations, data management and decision-making processes. Our first blog in the series presents a comprehensive approach to validating AI and ML integration in LIMS and ELN by leveraging […]

Quality Assurance, an Asset in Driving Customer Satisfaction

Quality is one of the most important aspects of customer service and satisfaction in any business.  In an age of metrics and key process indicators, quality is one of the easiest and most effective ways for monitoring the success of a business or service provider.  With this in mind, the steps a business takes in relation to […]

How to ensure FDA CAPA compliance?

3 min read As stated in our blog about Mature Quality Management Systems, quality is the foundation of a successful business. In this blog we cover the important differences between corrective action and preventive action, the purpose of the CAPA subsystem and FDAs expectations from your CAPA process.  Let us start with the basics: what is CAPA?  CAPA is […]

How to adopt a continuous, proactive approach to quality.

3min read Last month, Pinnaql attended a public meeting to explore and better understand how stakeholders perceive and value the quality of pharmaceutical products. The public meeting was facilitated between the Center of Health Policy at Duke University in partnership with the FDA. The FDA leadership and staff provided comments on the Agency’s current thinking […]