Blogs
Our Blogs
Disinfectant Efficacy Studies
Disinfectant Efficacy Studies are critical to maintaining the sterility and cleanliness of cleanrooms in industries such as pharmaceuticals, biotechnology, medical devices, and healthcare. In these…
Designing GMP facilities? Consider layout, equipment, materials, personnel, and quality control.
Designing GMP facilities Designing a pharmaceutical manufacturing site layout involves careful planning to ensure efficiency, compliance with regulatory standards, and a safe working environment. Here…
Data Integrity in the Life Sciences Industry “Components and the Regulatory Expectations”
Data integrity is essential to ensuring data accuracy, reliability, and consistency across various fields, including the life sciences industry. Regulatory bodies, including the FDA, emphasize…
CSV I ISO Setup I Data Security I IT Setup : How ISO Standards Can Transform Your Data Security into a Competitive Advantage
Ensuring Compliance and Efficiency with ISO Standards in GxP Environments In regulated industries such as pharmaceuticals, biotechnology, and medical devices, Good Practice (GxP) guidelines set…
CQV: The Art of Balancing Efficiency and Safety in a New Facility
Commissioning, Qualification, and Validation (CQV) are essential steps in the lifecycle of a new facility, ensuring that it operates safely and efficiently according to predefined…
Construction Plan: How Construction Planning Drives Sustainability in Biologics Manufacturing
Construction Plan for a Biologics Manufacturing Facility A construction plan is a blueprint for a facility’s physical build and systems integration. It ensures the project…
Computerized systems: Designing a well-structured privileges matrix for computerized systems
Designing a privileges matrix for computerized systems is a critical process that involves defining and assigning access rights to different users or groups within the…
Computerized System Validation: Navigating the Regulatory Landscape
Computerized System Validation (CSV) is a critical process in the life sciences and pharmaceutical industries to ensure that computerized systems, such as software and hardware…
Computerized System Validation (CSV)
Computerized System Validation (CSV) is a critical aspect of ensuring that computerized systems used in regulated environments, such as pharmaceutical and medical device industries, are…
