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Related Information
Articles & White Papers
Customer Solutions
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Pharmaceutical lndustry Solutions
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 Validatable Datalogging System
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Applications
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Challenge
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Relative humidity and temperature are critical control parameters in the processing and storage of pharmaceutical product.
FDA regulations require validation of these parameters as an essential part of GMPs and quality assurance, as detailed in 21 CFR Parts 210, 211 and 820.
Traditionally chart recorders and bulky data acquisition systems have been used by the pharmaceutical industry in process validation.
More recently, palm-sized, battery operated electronic data loggers provide a more compact and cost-effective alternative.
A challenge the pharmaceutical industry has struggled with is the integrity of electronic data files, as detailed in 21 CFR Part 11.
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Regulatory Compliance
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Process Validation Requirement
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Process Validation is a requirement of the current Good Manufacturing Practice as detailed in Sec. 211.100/110/113 of 21 CFR Parts 210 & 211, for finished pharmaceuticals, and Sec. 820.75 of 21 CFR Part 820 for medical devices.
Process Validation is defined as establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.
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Electronic Records Requirement
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21 CFR Part 11 details the criteria under which the FDA considers electronic records to be trustworthy and reliable and may be used in lieu of paper records in submissions to the FDA.
Subpart B Section 11.10 details procedures and controls to be employed to ensure the authenticity, integrity, confidentiality and validity of electronic records.
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Solution
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Veriteq's VL-series palm-sized precision humidity/temperature data logging system provides a complete monitoring, recording and reporting solution for use in FDA regulated validation applications.
Designed for use within the framework of a company's GMPs as an integral part of process validation, the VL-series provides confidence to all parties, including the FDA, that records are a genuine representation of actual conditions, in accordance with 21 CFR Part 11.
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Features
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- Tamper proof data logger for secure in-field operation
- Tamper proof files to ensure integrity of electronic records
- User verification of secure data
- File security and user verification indicators
- NIST-traceable calibration certification for performance verification
- Palm-sized, portable, 10 year battery operation
- High performance internal temperature & humidity sensors, optional remote thermistor probe
- Non-volatile memory, adjustable sampling rates, 1 year max. data recording capacity
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Data Logger Security
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The VL-series data logger is a physically secure unit with no keypad, switches or display which can be tampered with, ensuring integrity of its operation in field.
The VL-series data loggers are palm-sized, portable, battery operated devices ideal for quick and flexible deployment with no need for wiring, paper chart replacement, special probes or lengthy set up.
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Traceability
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A unique serial number and password-protected calibration data are stored in the loggers memory. This is an essential part of Veriteq's quality assurance programme and provides a means of tracking each data logger and verifying the validity of its recorded data.
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Performance Verification
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Each logger is performance tested and calibrated over the specified operating temperature range.
Veriteq performs NIST-traceable relative humidity and temperature calibrations in a Thunder Scientific Model 2500 Two Pressure Humidity Generator with a rated NIST-traceable RH accuracy of +/-0.5% RH over 10 to 98%RH and 0 to 70 Deg. C.
NIST-traceable calibration certification provides documented evidence of performance verification.
Disabled user calibration settings protect the validity of recorded data by preventing unauthorized re-calibration.
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Secure System Operation
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vLog software is a simple yet powerful Windows based software package for secure data logger interface, graphing and reporting operations. Password protected user access ensures only authorized system operation.
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File Authenticity
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Tamper proof files ensure the authenticity of electronic records.
vLog Software can recognize whether a data logger file has been modified from its original state by referencing an authentication signature which it has embedded in each file. If the file has been modified or tampered with, it is rendered unusable by the program.
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Authentic Reports
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vLog software generates secure password protected and encrypted electronic records, the original version of which is verified for authenticity and labeled from which it can never be modified.
Password controls ensure that the person who created the original electronic record is the same person who outputs a paper record.
Paperbased records can be printed from original secure and verified electronic records in a suitable format for approval sign-offs and subsequent inspection, review and submission to the FDA.
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System Responsibility
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It is intended that the validatable features of the VL-series data logging system form an integral part of a complete system to control the integrity of electronic data in accordance with 21 CFR Part 11 regulations.
It is the responsibility of the persons using the VL-series products in FDA regulated environments to implement controls within the framework of the company's GMPs and in conjunction with the requirements for process validation as detailed in 21 CFR Parts 210, 211 & 820.
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