What is HVAC? HVAC stands for Heating, Ventilation, and Air Conditioning. It refers to the technologies and systems used to regulate indoor environmental conditions, ensuring…

Navigating GxP Compliance in Cloud-Based Systems Navigating GxP (Good Practice) compliance in cloud-based systems is essential for industries like pharmaceuticals, biotechnology, and medical devices that…

Contamination Control Strategy (CCS) Definition: A Contamination Control Strategy (CCS) is a structured approach designed to minimize the risk of contamination in sterile manufacturing environments…

Medical devices encompass a wide range of products designed to diagnose, monitor, treat, or alleviate medical conditions. The regulatory landscape for medical devices varies globally…

What is Thermal Validation? Thermal validation ensures that temperature-controlled environments meet specified product safety, efficacy, and quality requirements. It involves measuring and documenting the thermal…

Maintaining precise and accurate measurements is critical to ensuring pharmaceutical products’ safety, efficacy, and quality in the pharmaceutical industry. The master calibration schedule is crucial…

ISO 13485 in Medical Device An ISO 13485 consultant is a qualified professional who can help medical device manufacturers implement and maintain an ISO 13485…

What is International Regulatory Framework (IRF)? The IRF or International Recognition Framework is a new initiative that aims to streamline the regulatory approval process for…

Internal auditing is a crucial component of the pharmaceutical industry. It is responsible for ensuring compliance with regulations, maintaining product quality, and managing risks associated…