Standards

Hi! I'm looking for guidance on complying with New York State Department of Health Clinical Laboratory Standards of Practice. LIMS S4 states "The laboratory shall validate any system changes, including new or revised software and/or hardware prior to their use for specimen testing, reporting and record keeping functions." With agile development, our IT team releases changes to our laboratory reporting tool on a bi-weekly basis. Reading the interpretation, it appears as though we should be performing validation on the tool bi-weekly, which seems a bit excessive. We perform UAT, retain approvals, change records, and maintain versioning control, but according to the guidance, this alone does not seem sufficient - even for minor bug fixes. Does anyone have any advice on how they've implemented this requirement in their environment? Thank you!

The amount of validation required by health authorities is commensurate with the level of risk. I first recommend you execute a risk assessment to determine the level of rigor for your validation of this system. 


From the high level description you give, you may be doing the right things. Let's start with ASTM E2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, which most folks consider a good basis for pharmaceutical systems, including GLP which I think you are aligned to (not positive but going to assume for the rest of my response that GLP is a good baseline). ASTM E2500-07 basically describes 4 phases of a lifecycle approach: requirements, specification & design, verification, and acceptance & release. Following the lifecycle approach, you are in operations, doing continuous improvement.


So my next question is how risk based or thorough are your UATs - do they include unit testing, integration testing, functional testing and acceptance testing to the level required - and is your Agile team ensuring traceability is appropriately documented - really how well documented is everything because that's often a stumbling block.


A good resource for the Pharma industry's perspective is ISPE's GAMP 5. Highly recommended, and it contains a lot of GLP thought and very aligned with regulator's thinking. Not sure, again, about the NY Department of Health, but I know in other states you would be very safe to align to it.


Be happy to discuss more specific instances and tactics.

Thank you for your insights. I appreciate the suggestions very much.