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The second stage of the validation lifecycle is called Process Qualification. This stage is customary and is referred to as Cleaning Validation. Usually, three consecutive successful runs are performed to qualify the process using well characterized, well documented and consistent cleaning procedures.

Traditional computer software validation (CSV) focuses on documentation. Computer software assurance (CSA) focuses on critical thinking.

Learn how we helped a customer find the root cause of a problem in monoclonal antibody (mAB) production and become stronger.

Traditional equipment validation is a manual, inefficient paper-based process plagued with bottlenecks and high cost. It's time to go digital.

Critical thinking is a vital life skill and the principal requirement of CSA. Are you a critical thinker? Read on to find out.

There's a need to accelerate pharma product development and process scale-up. Having an effective tech transfer strategy can help you.

The thinking is the more paper you generate, the better you validate. According to the FDA, this is not only wrong, it's dangerous.

Digital validation and automation meet complex product lifecycle needs but they're only enablers to the intelligence at the heart of manufacturing activity. Learn how ValGenesis is expanding its product vision beyond validation toward a holistic manufacturing intelligence platform.

Changing mindsets from compliance-centric to quality-focused isn’t easy. It’s possibly the most difficult change to make, but it’s necessary for a quality culture to take hold.

Each of the above is important. However, the critical point is that data integrity should be designed into the system right from the beginning. Data integrity should be at the forefront of system development (i.e, design).

Cloud-based digital validation allows you to recover in the event of a disaster, ensuring business continuity and compliance.

An important, and sometimes challenging, step in every product lifecycle is the point when it gets its premarket or a postmarket regulatory approval by the FDA. Luckily, through a combination of good practices for Benefit-Risk Assessment and technology, this has become much easier.

In this blog post, we’ll go through some concepts on Knowledge Management and the starting points for its implementation.

Unlock the potential of IoT in validation and manufacturing to enhance efficiency, reduce costs, and improve product quality across pharmaceutical operations.

A light story about how ValGenesis joining on a quest to optimize a stage in a process, how did we do it and what came out of it.