ProcessPro® Premier

FDA Compliance

Premier provides security audit trails and electronic signature options to help organizations become compliant with 21 CFR Part 11 Electronic Records and Electronic Signatures Final Rule.

• Maintain security requirements at login with a required combined code for user ID and password.
• Privileges allow the system administrator flexibility to assign access levels to multiple user groups or individuals.
• Privilege maintenance allows the administrator to control user access by function, time of day, and date range.
• Encrypts user IDs and passwords for added security.
• Users can view records without having the authority to edit.
• Each user has a unique password and user ID.
• All previous and current user information is tracked and cannot be reassigned.
• Generates user aging reports to automatically create password expiration reminders.

Electronic Signature

• The user’s name appears on the screen to reduce inadvertent entries.
• Provides an option for required user ID and password login at subsequent sessions of processing, including security checks to authenticate user ID, password, and privilege for desired use.
• All executed electronic signatures are linked to their respective record.
• Record second signature on QC test results entered and batch ticket postings.

Audit Trail

• Bill of Material Product Tracking Log provides a robust audit trail for formula creation, modification, deletion, and activation status.
• Features a complete batch ticket audit logging report of all material transactions with associated user ID, date, and time stamp.
• The audit trail is secure from modification or deletion, and has archiving ability for record keeping.
• Secure, computer-generated, time-stamped audit trails record the date and time of operator entry, including creation, modification, or deletion of records.
• Tracks system user group, authentication details, and workstation information.

Validation Services

ProcessPro’s Technology Implementation Plan (TIP) for the FDA market was created specifically for manufacturers that require software validation. This implementation plan, coupled with the validation Deliverable Package, provides the plans and deliverables necessary to help clients meet validation requirements.

Standard Reports

Each report may be customized from a matrix of user-selected options, may be displayed, printed, exported to a spreadsheet, faxed, e-mailed, or saved on disk. Available reports include:
• Users Report
• Password Report
• Privileges Report
• Installation Report
• E-Signature Report