The MDS Audit and QC module allows you to audit any document or transaction in the MDS system.
"She Blinded Me With Science" is a New Wave song by British musician Thomas Dolby, released in 1982.
what does that have to do with this post? The song's chorus, "She blinded me with science", plays upon the colloquial British expression "to blind [someone] with science", meaning to deliberately confuse someone by giving the impression of highly complex knowledge. Well in our own way we now can use the same technique within the MDS system. For those not familiar here is the video.
This Module is designed to allow your company to comply with 21 CFR 211 - (1) Sample size
and test intervals based on statistical criteria for each attribute examined.
While there are many methodologies used in sampling, the MDS QC and Audit Module offers "Systematic
sampling" as a method of choosing which documents to check.
Systematic sampling relies on arranging the study population according to some ordering scheme and then selecting elements at regular intervals through that ordered list. Systematic sampling involves a random start and then proceeds with the selection of every kth element from then onwards. In this case, k=(population size/sample size). It is important that the starting point is not automatically the first in the list, but is instead randomly chosen from within the first to the kth element in the list. A simple example would be to select every 10th name from the telephone directory (an 'every 10th' sample, also referred to as 'sampling with a skip of 10').
Once a document or transaction is flagged for audit the system will automatically create a task assigned to a a specific user to complete the function and update any additional steps in your audits. By combining a little bit of science with a simplified audit capability the MDS QC and Audit system now allow your company to comply with regulatory concerns, Industry Best Practices and statistically measure and improve and critical processes.
For more information on TSH or MDS call The Systems House, Inc. at 1-800- MDS-5556. Or send a message to sales@tshinc.com
