Eminence Business Media

Eminence Business Media

Tuesday, June 5, 2018

New pharma workflow offers secure auditing processes for pharma packaging

The EyeC Proofiler offline inspection system from EyeC now offers improved workflows for pharmaceutical companies. The new software version, 3.4, meets the newest requirements for data integrity, data security, and audit trail during inspection of pharmaceutical packaging. Pharmaceutical companies can, not only perform fast and automated print sample testing, but also increase the security of their data and processes. All data can be simply and securely retrieved and presented during later audits.

Improved data security and audit trail
All inspection data necessary for future audits are saved in the EyeC Proofiler’s audit trail. When used in a pharmaceutical company, the user must enter the job number to document the inspection. Each individual scan that is part of the inspection process is documented, including multiple scans. This lets pharmaceutical firms ensure that their auditing processes can always be checked transparently.

Ensuring data integrity
All data from any scanning process, including all scanned images, are automatically stored by the proofing system before they are displayed on screen. Thus, companies can rule out data manipulation. Moreover, the new software contains an obligatory comment function for multiple scans and changes to parameter sets.

Double-Check Workflow for secure auditing processes
Using the Double-Check Workflow, EyeC Proofiler ensures that a second operator checks the evaluation of the first auditor according to dual control. He can review the completed inspection either in the audit report or in Proofiler’s user interface and initiate any necessary changes when appropriate.

Simple and comprehensible visualization for audits and audit trail reviews
The new version of the Proofiler software displays all inspection data in a very user-friendly way. The audit trail data is protected and cannot be altered. The audit trail is built as a clearly structured CSV file and can be filtered for categories and evaluations. Critical events are immediately detected during the audit trail review and can be commented on. The improved visualization represents considerable time savings during process control and during an audit.