On-site and Remote Inspection Management Regulatory inspections can be some of the most intense and stressful activities on a highly regulated company’s path to commercial success. Learn what to expect from an on-site or remote audit, how to prepare to eliminate...
News & Blog
Innovations in Validation: Advancing Cell and Gene Therapies
With the ever-changing mechanics of innovation in the manufacturing environment, work from home and federal regulation validation strategies need to evolve to accommodate the new space. This white paper provides the background, rationale, and strategy for innovating...
Use of Multi-Disciplinary Validation Teams for GXP Projects White Paper
Maximize efficiency and effectiveness in your validation projects by utilizing multi-disciplinary teams. The term "Validation," as used in this white paper, will be taken to mean either or both activities of Qualifying systems and facilities as fit-for-purpose...
Applications for Quality Risk Management in Facility Operations
This is the final installment in PSC Biotech®’s series on Quality Risk Management (QRM) in Commissioning and Qualification (C&Q). This follows on the concepts introduced in the first four installments: QRM in C&Q Planning Risk Assessments – One Size Does Not...
Microbial Contamination Control White Paper
Microbial contamination control encompasses many areas in the manufacturing process. You can control contamination using multiple practices and procedures aiming to minimize contamination. In this white paper, we provide valuable information on the history, validity,...
CSA vs. CSV White Paper
As a regulated company, you need to ensure your computer applications meet your needs for functionality, patient safety, product quality, and data integrity. Unneeded documentation, redundant testing, and perceived regulatory burden distract us from our primary goals...
Quality for Small Businesses in the Food Industry White Paper
Quality for small businesses is often overlooked. Creating and establishing a small business is not an easy endeavor - it requires hard work and dedication. Quality is the foundation that will bring that small business alive. It is at the core of any successful...