ProFicient has built-in features that help you comply with government regulations and industry standards for quality. With ProFicient in place, audits are easier with instant access to quality records and electronic documentation needed to demonstrate compliance.
ProFicient’s 21 CFR Part 11 features help protect FDA regulated companies, but they also empower those who want to ensure the integrity of their data through good security and traceability practices.
ProFicient also has specific features to address food manufacturers' needs for an enterprise quality system that supports Hazard Analysis and Critical Control Point (HACCP), Sanitation Standard Operation Procedures (SSOP) and Net Content Control compliance.
Lot Genealogy and Traceability
ProFicient’s Lot Genealogy and Reporting features allow organizations to track raw material lot codes throughout manufacturing operations. For investigation purposes, genealogical "trees" can be created for any Lot. These reports allow you to determine:
- Materials used in the production of a certain finished lot
- Where incoming raw materials were consumed
- Root causes of non-conforming lots
- Information critical to responding to product recalls
- Which final lots were created from incoming lots
Lot Genealogy reports provide a complete view of the incoming/outgoing product relationship complete with statistical summary information.
FDA 21 CFR Part 11
The strict access control features support all the technical requirements of 21 CFR Part 11 including Password Aging, Recycling, Lockouts, Length and Encryption.
The Automatic Security Violation Logs track and report security violations by individual users and their location. Automatic Access Logs track individual user access into and out of applications.
ProFicient also offers Automatic Audit Trail Logging which provides a history of all changes made to any database record including sample data, limits and alarm rules. It also features Special Reporting Options that include Change History, Metadata, Specification and Control Limit outputs. More >>
HACCP, SSOP and Net Content Control
With ProFicient, you can incorporate workflow requirements at the shop floor level, allowing automatic prompting to operators when data collection is required. InfinityQS’ real-time Dynamic Scheduler offers a visual checklist to the operator, reminding them when HACCP, SSOP and other critical quality checks must be performed.
You can specify unique, time-based intervals based upon the product, process, or even the workstation. Windows automatically pop up, clearly identifying when data collections are due. If a failure is detected or if no data is collected, ProFicient can automatically send notifications, email administrators, or even force users to specify assignable cause codes and corrective actions. Watch the video.
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Dynamic Scheduler
Manufacturers in the food and beverage industries must also comply with filling requirements for Net Contents (weight) control. The Net Content Control feature in ProFicient supports both MAV and T1/T2 requirements and related Net Content Control reporting to support the needs of global manufacturers.
Database Auditing
When enabled, Database Auditing provides full traceability for any modification, edit or change to any database record. Traceability records are easily viewed in a variety of ways, but they cannot be edited. Whenever a record modification or deletion is attempted, ProFicient’s “Reason for Change” tracking feature forces users to select a reason for the modification from a drop-down list. Additionally, free-form comments are required. When specified, a Change History and Reason for Change Report can accompany any chart printout.
