Common Mistakes in Computer System Validation
Modern scientific laboratories increasingly rely on computerized informatics systems (e.g., LIMS, ELN, CDS, etc.) to process and manage data. To ensure product safety and effectiveness, it is important for these systems to be validated in a process known as computer system validation (CSV) to confirm the accuracy and integrity of processed data. Regulatory agencies like […]
Pharma 4.0 and Validation 4.0 – The Challenges of Implementing
Pharma 4.0™ and Validation 4.0, as part of the plan, requires resources, information technology, a holistic control strategy, and a cultural shift of the organization. All areas need to come together to ensure that the business can make progress towards improvement and achieve the objectives. This can lead to challenges given the extensive impact on […]
Validation 4.0 – The Benefits to the Life Sciences Industry
The objective of Validation 4.0 is to provide a risk-based method for process performance qualification that involves a uniform, coordinated and unified approach to computer system validation. It is based on the Pharma 4.0™ operating model and includes a thorough control plan, as well as digital maturity and data integrity by design. The Benefits of Validation […]
Best Practices for Instrument Validation and Qualification
Analytical instruments provide important scientific data about manufactured products that serves to ensure that they meet specifications. These instruments run the gamut from simple apparatus to complex systems that combine a metrological function with software control. Laboratories operating in regulated environments are required to conduct instrument validation tests in order to produce documented evidence that […]
Best Practices for Computer System Validation
Computer system validation (CSV) is a documented process that is required by regulatory agencies around the world to verify that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. These regulatory agencies require CSV processes to confirm the accuracy and integrity of data in computerized systems in […]