scubasammy

Yes, CAs and PAs are both corrective in nature, but CAs are immediate and PAs are preventative. For example, say a volunteer checks the wrong box on a donor form, a supervisor discovers the error immediatley and corrects the error by checking the right box and signing off on the correction. Now, say the same volunteer does this three more times but the issue isn't discovered right away. First, you need to correct the error and second you may need to re-train the volunteer. However, the volunteer only works once a month and won't be back for 28 days. Are you going to keep the deviation open for 28 more days? It's better to close out the deviaition and CA while keeping the PA open until completed. The only way to trend accuratly is by keeping count of all events and the timeline for each activity. BTW, I don't think the regulators expect your CAPAs to be completed in 30 days unless your SOPs state that this is the timeframe for closure. They will however react if deviations, CAPAs, etc are not closed in a timely and consistent manner.

Rashmi, Our software is used by the top pharma, medical device, CROs and blood centers around the world for amongst other areas CAPA. In almost all cases the process is 1) corrective action 2) preventative action and 3) effectiveness check. CAs are short term immediate fixes, while an effetiveness check may not happen for weeks or months. Our recommended 'best practice' is to close the corrective action once completed, open a seperate preventative action referencing the original incident(s) and open an effectiveness check on both the CA and the PA. Some companies will allow the re-opening of a CAPA, but this should be only used when the original information (investigation results, root cause, etc.) needs to be ammended or changed. The agencies and management will be looking for how you corrected the problem, how long it took during each step (investigate, approve, implement) and how effective was the correction. If you leave a CAPA open for an extended period while awaiting an effectiveness check the metrics will be skewed.

as per the previous question about capa, a qms will manage from audits through to change management, training management, document control, etc. one system with various workflows and action items see sparta-systems.com if you want to read up on what a qms can do

If your looking for a quality management system to manage incidents, investigations, capa and reports, you may want to look at trackwise. its being used at 1/2 dozen blood centers in the states and is widely known around the life sciences world www.sparta-systems.com

TrackWise QMS - www.sparta-systems.com Part 11 compliant, handles quality incident reports, investigations, corrective actions used by several blood banks

there are a number of different off the shelf products for quality management that are 21 CFR Part 11 compliant. two that I know work well are Master Control www.mastercontrol.com and TrackWise www.sparta-systems.com.

There are software systems that conform to the FDA rules for 21 CFR and specifically Part 11 (electronic signatures). They have built in workflow processes so managers, supervisors, donors and the FDA can be notified either via letter or email whenever an adverse event happens. They all work with both paper and electronic copies of records, the processes can be validated and they hold audit trails of all records. These are not donor, lab, or temperature control systems. They are used for 1) recording an adverse event 2) investigating why or how it happened (3 putting a CAPA plan together to make sure it doesn't happen again and 4) making sure the action plan works. They also can be used for document control (SOPs, etc.), training records and auditing of the departments to make sure they are following the SOPs. check out www.sparta-systems.com for info on one of the products.

There are systems in use at several blood donor organizations that track and manage adverse events, deviations, non-conformance, SOP audits, documents and CAPA (corrective and preventative action). Is this what you are looking for?