21-CFR PC SOFTWARE AND CONNECTIVITY - FOR TENSILE TESTING MACHINE

EIE-TenSoft is a specially designed Windows-based, fully integrated data acquisition and control Software designed to support US FDA 21 CFR Part 11 requirements, incorporating secured role-based user access, password protection, electronic records, electronic signatures, computer-generated time-stamped audit trail, data integrity controls, test-method management, graphical analysis, automatic calculations, controlled reporting, historical data retrieval and backup/restore facility

🔹Regulatory Compliance

1. Designed to support USFDA 21 CFR Part 11 requirements
2. Supports Electronic Records & Electronic Signatures (ER/ES)
3. Secure, computer-generated audit trail
4. Automatic date & time-stamped electronic records
5. Suitable for use in GMP / GLP pharmaceutical quality-control laboratories

🔹Core Functional Capabilities

1. Windows-based graphical user interface (GUI)
2. Communication interface for direct connectivity between Tensile Testing Machine and PC
3. Machine operation, test configuration and data acquisition through software
4. Creation and storage of product-wise / test-wise test methods
5. Real-time display of Force, Extension/Displacement and Test Status
6. Real-time Force vs. Extension / Displacement graphical curve
7. Automatic calculation of applicable test parameters such as:
8. Peak / Maximum Load
9. Breaking Load
10. Tensile Strength
11. Elongation / Extension
12. Peel / Seal Strength
13. Average Load / Average Strength
14. Other test-specific parameters, as configured
15. Menu-driven architecture for easy operation

🔹Data Integrity & Storage

1. Automatic date & time stamping of test records
2. Secure storage of test parameters, results and graphical data
3. Unique identification of individual test records
4. Large data storage capacity, subject to PC/database capacity
5. Search and recall of previously stored test records
6. Automatic statistical calculations including Average, Minimum and Maximum, as applicable
7. Selectable engineering units for Force, Strength and Extension
8. Protection of stored electronic records against unauthorized modification

🔹 Audit Trail & Traceability

1. Secure and time-stamped audit trail for critical activities including:
2. User Login / Logout
3. Test creation and execution
4. Test method / parameter changes
5. Data modification or deletion, wherever authorized
6. User and access-right changes
7. Critical system configuration changes
8. Electronic review / approval activities
9. Audit trail records protected against unauthorized editing
10. User identification associated with relevant activities
11. Provision for recording reason for change, where applicable
12. Historical traceability of critical electronic-record activities

🔹User Access & Security Controls

1. Secure login using unique User ID & Password
2. Role-Based Access Control (RBAC) with three hierarchical levels:
3. Administrator
4. Supervisor
5. Operator
6. Configurable privileges according to user role
7. Password-controlled access to critical functions
8. Controlled authorization for test-method creation, modification, review and approval
9. Electronic signature authentication for designated approval activities, where configured
10. Restriction of administrative functions to authorized users

🔹Reporting & Export

1. Automatic generation of comprehensive test reports
2. Reports can include:
3. Product / Sample Identification
4. Batch / Lot Number
5. Test Method & Parameters
6. Operator / User Details
7. Date & Time
8. Numerical Test Results
9. Force–Extension Graph
10. Statistical Results
11. Review / Approval Details
12. Facility for Company Name / Logo on reports
13. Controlled report generation in PDF
14. Test/result data export to Microsoft Excel-compatible format, where enabled
15. Print-ready test reports for documentation and review

🔹Pharmaceutical Industry Advantages

1. Supports data integrity and traceability throughout tensile/peel/seal testing
2. Minimizes manual data-entry and transcription errors
3. Facilitates controlled electronic test records and audit review
4. Supports computerized-system validation requirements
5. IQ / OQ documentation can be provided as per supply scope
6. Suitable for pharmaceutical QA, QC, R&D and packaging laboratories

🔹 Typical Applications

1. Pharmaceutical Packaging Material Testing
2. Blister / Strip Packaging Peel & Seal Strength
3. Medical & Pharmaceutical Pouch Seal Strength
4. Adhesive / Label Peel Strength
5. Rubber Stopper / Elastomer Component Testing
6. Plastic Film & Flexible Packaging Tensile Testing
7. Medical Device Component Pull / Tensile Testing
8. Quality Control & R&D Laboratories