Quality & Compliance
The Role of Quality for Commissioning Success
The commissioning process is defined as "a quality-focused process for enhancing the delivery of a project. The process focuses upon verifying and documenting that all of the commissioned systems and...
Clinical Research Solutions
How Do You Stay “c”?
Trying to remain compliant with the current Good Manufacturing Practices (cGMP) has its challenges and opportunities. I would like to discuss the opportunity afforded by the ASTM E2500 "Standard...
Clinical Research Solutions
Quick Guide: Coordinating a Laboratory Move
Moving an operational Quality Control Laboratory is all about maintaining the support of production testing, ensuring physical integrity of the instrumentation being moved, and qualification of the...
Clinical Research Solutions
Are you spending too much on lifecycle costs?
ASTM E2500 – Risk-based testing has been in play for several years now. By design, there is a significant opportunity to avoid many lifecycle costs without creating an adverse impact to quality or...
Clinical Research Solutions
Three Solutions to Typical Autoclave Temperature Mapping Conundrums
Temperature Mapping is an intrinsic part of equipment validation. It evaluates the quality and compliant nature of the equipment to ensure the equipment meets the user and regulatory agency’s...
Clinical Research Solutions
Calibration and Verification: Are you using these terms correctly?
No matter where I go I am always amazed at how many times the words calibration and verification are misused. I often hear statements like, “The instrument doesn’t need to be calibrated, the accuracy...
Clinical Research Solutions
Are Your SOPs "Reference-Crazy"?
While Standard Operating Procedures (SOP’s) are widely and rightly used to control processes, there is sometimes a tendency within organizations to go “reference crazy”. In a well-meaning attempt to...