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21 CFR Part 11 Data Integrity Software for Container Closure Integrity Testing Systems

Source: PTI Packaging and Inspection Systems

21 CFR Part 11 Data Integrity Software for Container Closure Integrity Testing Systems

PTI has developed a new standard for protecting, storing and presenting data generated from its line of non-destructive leak testers in the form of a software package called PTI Ethos.

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PTI Ethos collects and protects the data in an SQL server while serving as a simple and convenient method of interacting with the leak tester, data reports and audit trails. Reports can be customized to suit our customer’s needs more effectively to their internal standards. The user base is tied to the pre-existing customer managed Windows Active Directory for simplified password management and user access to PTI Ethos. The software also provides user-friendly tools to assign e-signatures to all data reports as either “Review” or “Approve” along with database search and sorting tools. All reports can have a copy printed or exported to PDF at the customer’s discretion while the original master copies remain secure within the database.

Key Features

  • Secured SQL Server Database stores all information
  • Data stored in the database cannot be edited or deleted
  • Row Check Sum performed on all data to check for database tampering
  • Results are logged into database at the time of test completion
  • Reports are customizable to customer needs
  • Full audit trail and recipe history reports can be generated
  • Database is sortable and searchable for simplified report retrieval
  • Electronic signatures for “Review” and “Approve”
  • Complete audit trail of PC software and tester alarms

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