How many times have you heard the expression “He who fails to plan, plans to fail”? Probably more than you can count since it’s attributed to several prominent individuals. Let’s face it, if we don’t know where we are going, then how will we know when we have arrived? The same concept applies to Computer… Read More

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

Have you ever been working on the Computer System Validation (CSV) of a Laboratory System and hit a brick wall?  The validation comes to a standstill because the software/hardware does not meet one of three main aspects of computer system validation testing: Does not function as intended Does not meet an aspect of 21 CFR… Read More

If your laboratory is operating in a regulated environment, then you are faced with the challenge of ensuring your operations and systems are ready to withstand the scrutiny of a regulatory audit, or else face the consequences.  But depending on your industry and your environment, different regulations may apply.  For laboratories using computerized systems to… Read More

In a previous blog we talked about how small to medium sized businesses were readily adopting Cloud Informatics Systems (LIMS, ELN, SDMS) while large businesses were moving more slowly in this direction.  We did not discuss whether businesses in regulated industries, with their needs to validate their informatics systems, are able to adopt cloud based… Read More