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

Hey, does this sound familiar: The lab just bought a new [Enter Name/Type of Instrument or Data System] before the fiscal year closed. It just showed up and now they are after you to validate it now! Get it done fast – right, no problem but validating a scientific instrument software or lab data system,… Read More