E-Signature

Creation and management of controlled audit logs of accurate, time-and-date stamped, and unalterable data mitigate risk of failed regulatory audits. Our solution provides procedural and technical controls required to meet the FDA’s 21 CFR Part 11 (Federal Regulation required by the US Food and Drug Administration to protect Electronic Records and E-Signatures)

Required changes and overrides can be made by authorized personnel, approved by managers and are documented in audit files to maintain an accurate record. Secured data points can be set up to require single or dual-level authentication.

Electronic signatures executed are linked to their respective electronic records. Audit trails provide name of signer, date and time when signature was executed and reason for change.

Advanced Analytics

The pharmaceutical industry demands more than simple trend logs and alarms — comprehensive data analysis is crucial. Advanced analytic algorithms are essential for predicting the impact of conditions during the storage and transport of sensitive medical products. Ontrol leverages Niagara’s Analytics Framework to delve into historical data, enabling verification and documentation of critical environmental conditions.

A good example is calculation of Mean Kinetic Temperature (MKT), a key parameter used to assess the impact of
temperature fluctuations on perishable pharmaceutical products. The complex set of computations on historical data required for this calculation is only possible through advanced analytics.