Ask the Consultant: Computer System Validation Advice

Computer System Validation is an essential and complicated task for regulated computer systems.  It can be challenging, which is why learning from each validation performed can help make all future validations easier, with fewer deviations.  This learned experience can only be obtained from executing a validation and not just learning how to perform one. Each… Read More

What’s in Your Vendor Validation Kit?

When deciding to make the purchase of a computerized system for your lab, it is important to know which areas require compliance. Testing of a laboratory informatics system (LIMS, ELN, CDS, SDMS), that is required to be compliant, is mandatory. Vendors supply their systems with appropriate validation documentation that is, in part, a basic outline… Read More

7 Validation Mistakes You Don’t Know You’re Making

Validation Plan? 🗸Test Scripts? 🗸Testers and Approvers? 🗸 Your Computer System Validation (CSV) project is underway. Or is it? The Items checked above, in addition to a few other documents, are key to the success of your CSV project.  However, within those items, there are crucial details that can easily be overlooked or oversimplified opening your organization to… Read More

Clinical Supplies Management System Implementation and Validation – The 3 Dos and Don’ts

When implementing a Clinical Supplies Management System (CSMS), there are several industry best practices that will help yield a successful implementation, deployment, and validation.  Simply automating your paper-based process in the new CSMS, while feasible, may not yield the best benefits for your organization.  Proper planning including: needs assessment, requirements gathering and documentation, and process/workflow… Read More