OM-CP-SVP-SYSTEM-Series

Supported Applications

The Omega OM-CP-SVP-SYSTEM is secure software designed for use with the OM-CP Series data loggers. It provides secure data management and compliance support specifically for pharmaceutical, medical, hospital, and FDA-regulated organizations. The system supports temperature mapping applications where adherence to 21 CFR Part 11 requirements is necessary.

Operating Conditions & Performance

The OM-CP-SVP-SYSTEM operates as a software solution; physical specifications such as measurement range, accuracy class, or environmental ratings are not applicable. The system ensures data integrity through proprietary file formats and secure database storage. Key performance characteristics include:

• Proprietary .MTFFS file format that cannot be opened by other software.
• Automatic saving of downloaded device data to an internal secure database where records cannot be altered.
• Generation of visual representations in grid, graph, and statistic formats from stored data.
• Secure, encrypted audit trails recording date, time, and operator for all salient operations.

Configuration Options

The series is offered as a single software configuration: model OM-CP-SVP-SYSTEM. The system provides configurable user access control levels defined by the administrator to restrict features based on authorization. Communication capabilities are limited to proprietary protocols with uniquely identified OM-CP Series data loggers via electronic serial numbers.

Compliance Features

• User Access Control: Requires unique User IDs and passwords; access levels can be defined by the user.
• Audit Trails: Secure, encrypted logs of operator entries and actions that create, modify, or delete electronic records. Audit trails are retrievable throughout the retention period and cannot be deleted or modified.
• Electronic Signatures: Unique to each authorized individual; signatures are linked to their respective electronic records to prevent falsification via cutting or copying.
• Data Output: Supports printing of graphs, data records, device status, and audit trails on paper. Data files may be transferred electronically (e.g., by email) or printed as secure documents in formats such as PDF.

Key Product Differences

The OM-CP-SVP-SYSTEM is a dedicated software package for the OM-CP Series data loggers. While the system enforces specific security protocols, certain 21 CFR Part 11 requirements require customer-defined actions rather than automated system enforcement:

• System Validation: The customer must execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to validate correct installation and operation.
• Standard Operating Procedures (SOPs): Customers are responsible for developing SOPs regarding user ID/password sharing, sequence of system steps, written policies on individual responsibility for electronic signatures, and training documentation.
• Licensing: Distribution and use of the software and supporting documentation must adhere to licensing terms controlled by the customer.