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 is a robust solution that can stand up to an FDA or internal audit while easily meeting the challenging requirements of 21 CFR Part 11. ProFicient boasts built-in checklist features needed to comply with Hazard Analysis and Critical Control Points (HACCP) and Sanitation Standard Operating Procedures (SSOP).
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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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.
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.
SPC software should benefit an organization through cost reductions and quality improvements, but our customers’ successes tell the story best.
Kraft Foods. Kraft’s global quality program is built around five core principles: Statistical Process Control (SPC), net content control, Hazard Analysis and Critical Control Points (HACCP), defect management, and audits. Kraft selected ProFicient because it was the most effective solution available to help them accomplish their goals in these key areas. Alarms are essential to HACCP. With ProFicient’s alarming features, Kraft has the ability to apply an immediate response if a critical control point does not meet their standards or if there was a failure to gather data. With their previous system, reactions to critical events would not occur until the end of the shift. Test results were taken to the quality lab for analysis where the response was managed. With ProFicient, alarms instantaneously notify the right people so that action can be taken immediately. By managing alarm notifications alone, Kraft plants have realized significant cost savings.
The Pepsi Bottling Company.The Pepsi Bottling Company uses ProFicient as a centralized lab management system for statistical analysis and control of their global manufacturing operations. The system enables all manufacturing sites to ensure they are in compliance with Pepsi's strict quality standards for all phases of product manufacturing. InfinityQS' Data Management System (DMS) allows automated data collection from Pepsi lab equipment worldwide. This direct communication with Pepsi's data gathering equipment creates an efficient, integrated system for managing and controlling their manufacturing processes. “Proficient is an easy-to-use, flexible and centralized system that provides us with real-time access to performance information at all of our plants around the world. This allows us to instantly compare information, identify best practices, and quickly replicate our success on a global scale.”-Tanya Peacock, The Pepsi Bottling Company.
Medtronic. At Medtronic Surgical Technologies, several thousand different part numbers are checked for quality compliance using a variety of different electronic gages. ProFicient helps Medtronic easily manage these part records and comply with thousands of related specification limits. Additionally, traceability and security features built into ProFicient make it simple to adhere to the FDA’s 21 CFR Part 11 regulations regarding Electronic Signatures. Lastly, to help Medtronic with software validation, InfinityQS provided test cases, validation scripts and services so that Medtronic could perform a full functional verification of their ProFicient installation.