How is SmartControl validated?
SmartControl can be used as part of GMP-regulated activities, and the data it stores can be used as the electronic record for predicate rules stated in 21 CFR Part 211 (namely 211.188(5), 211.192 and 211.194a). SmartControl is designed to comply with Eudralex Vol 4 Annex 11 and is technically compliant with 21 CFR Part 11.
In addition to internal validation, and to avoid bias, Microgenetics employs third-party QA professionals to carry out validation of SmartControl.
How many samples can I manage in SmartControl?
How many users can be added to a site?
Is SmartControl compliant with 21CFR Part 11?
How do the quality assurance checks work?
Quality assurance sanity checking has been applied to the process of photo capture in SmartControl. These sense checks check for blurriness in the photo and check that the image of the plate has not been cropped.
How does SmartControl solve the need to double check every sample?
SmartControl solves this problem by capturing an image of every sample. This means that should a count ever be questioned, an image of the plate at the time it was read is available to anyone who wishes to look at the plate. Random spot checks of results versus count on the plate in the photo can also be carried out to ensure that operators are recording their counts accurately.
Who can see my data?
Only those users who are granted access to your site are able to access and see your data. Microgenetics staff do not have user logins that allow them access to your data unless invited to access your site by your site administrator. This is only likely to happen when support requests are generated.