ProCalV5 was designed originally for use in highly regulated environments, such as Pharmaceutical facilities and laboratory’s, but has become an extremely versatile tool in numerous other environments including Chemical, Power and all process related industries. With the highly flexible and configurable ProCalV5 software, gains in productivity, quality, and management can be experienced in such areas including Engineering, Research & Development, Quality Control and Production.

With our compliance experience in good manufacturing and laboratory environments, we have been able to successfully develop software that goes above and beyond the industry standard for calibration management.

Data Security
Once you have data into ProCalV5, you may protect it from unauthorized manipulation. ProCalV5 provides the following mechanisms to protect your data:

• Fully Compliant Audit Trail (21 CFR Part 11): All record entries and changes generate Audit details that are linked to their unique ID. Audit Trial tools include Server Date/Time Stamp, User ID, Reason for activity and User Authentication through “Double Electronic Signature.

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• Change Control System: Don’t confuse your technicians and staff by making changes directly to your production records before modifications are approved. Make changes instead by using ProCalV5’s Change Control feature and circulate the changes for approval electronically without disrupting operations.

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• Approval Policies: Avoid the time consuming delays and the uncertainties of distributing documents for review and approval signatures. ProCalV5 Users can define their own approval policies and apply them as desired to Item Master Records, Activity Results and Compliance Incident Reports.

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• Electronic Signatures: Prime Technologies is the leader in electronic records/electronic signatures for FDA 21 CFR Part 11 compliance. With ProCalV5, Prime Technologies was the first organization to successfully integrate this functionality into a calibration management software application.
  • Forced e-signature routings
  • Audit trail with ability to track all electronic signatures
  • Password re-authentication requirement on all database actions to ensure user identification
  • Maintain data integrity
    

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Compliance Management highlights include;

• Exceeds requirements for compliance with 21 CFR Part 11, ISO 9000, QS 9000, ISO 17025, and ANSI 254
• Compliance event reports and issues requiring action or approval or communicated electronically
• Approval Policies with multiple signature routings may be defined to suit the user’s business needs and practices
• Password re-authentication is required on all database actions to ensure user identification
• LDAP authentication capable
• Fully validated before release with scripts provided
• Master Record Change Control
• Multiple unlimited forced E-Signature Routings
• Audit Trial & Audit Trail Reporting Capabilities
• Fully compliant mobile workstation

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