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Does this system produce GMP-compliant records?
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The VL-series data logging system is a set of monitoring tools that have been designed for use within the framework of a company's GMP-compliant record-keeping and documentation system. The system produces paper-based data logging records that, after signed review and approval by responsible parties, can be used in a GMP-compliant documentation package. As a part of this process, the VL-series system creates and uses secure and unalterable electronic records consistent with GMP requirements for authenticity and accuracy.
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How do the FDA CFR 21 Part 11 requirements relate to the VL-series system?
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The CFR 21 Part 11 regulations apply to any electronic records that are used as a part of GMP documentation, including the ones produced by the VL-series data logging system.
The following table summarizes the key requirements of the CFR 21 Part 11 regulations and how the VL-series system addresses those requirements. (For a complete summary, request the "White Paper on Veriteq 21 CFR Part 11 Compliance".)
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CFR 21 Part 11 Requirement
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Reference
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VL-Series Features
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| All records shall be prepared, dated and signed (full signature, handwritten) by one person and independently checked, dated and signed by a second person. |
GMP 211.186 |
Password-protected system outputs paper-based records with appropriate form for review and approval sign-offs. |
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| Electronic records may be considered trustworthy and reliable and be used in lieu of paper records provided that the electronic records have proper security controls |
CFR 21 Part 11; Subpart A-Sec 11.1 Scope |
Software produces secure and encrypted electronic records that are used to produce printed documentation. Software recognizes invalid or altered data logger files and renders them unusable |
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| Ensure the authenticity and integrity of the electronic records such that the person responsible for the electronic record cannot readily repudiate the record as not genuine |
CFR 21 Part 11; Subpart B-Sec. 11.10 |
Tamper-proof data logger (no switches or buttons). Password-protected calibration record verifies integrity of recorded data. Password protection ensures that person who created electronic record is the same person who outputs a paper record |
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| Ensure that the system can discern invalid or altered electronic records |
CFR 21 Part 11; Subpart B; Sec. 11.10 (a) |
Software recognizes invalid or altered data logger files and renders them unusable |
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| Ensure that complete and accurate records in both human readable and electronic form are available for review and inspection by the FDA |
CFR 21 Part 11; Subpart B; Sec. 11.10 (b) |
Original raw electronic record is never modified and can be printed for review and inspection |
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What is meant by the terms "validation" and "validatable"?
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Validation is the process of proving that something does what it is supposed to do. It is a very important process in the pharmaceutical industry that is falling under increasing regulation. The FDA's definition is establishing through documented evidence, a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality characteristics.
The term "validatable" means capable of being validated. Three issues are essential before equipment can be considered validatable:
- There must be documented evidence of performance verification available. As an example of this requirement for documented evidence, a NIST-traceable calibration certificate is provided with every Veriteq VL-series data logger.
- The equipment must match the specific requirements of the application. Each application may involve special accuracy, operating range, performance stability or other requirements that the product must meet.
- The equipment must be capable of maintaining a validated state throughout the application process. The product or its output cannot be manipulated, changed or tampered with.
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Secure data logger files: What are they and why are they important?
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Secure data logger files are tamper-proof files created using vLog Software from a VL-series Validatable data logger. 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.
Secure files are essential when the data you are recording is very important or has a high liability attached to it. As an example, a pharmaceutical company may stand to lose a substantial amount of money if the storage conditions being recorded for a particular drug product are not within specifications. Since there is a possibility that an unscrupulous operator may attempt to alter the records to save his company money, a secure file provides confidence to all parties, including the regulatory agencies, that the record is authentic and a genuine representation of actual conditions.
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Has the FDA approved your data loggers?
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There is no such thing as "FDA-approved" products. The FDA only clears "human use" drugs and medical devices for interstate commerce without providing any level of endorsement for these products.
It is important to note that Veriteq products form an important part of the validation processes of many leading pharmaceutical companies and that these processes are subject to regular scrutiny from the FDA.
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Do you provide any assistance to validate this system for our facility?
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Yes. A Validation Protocol Manual and CD for the VL-series system is available. This time-saving package has been designed to help you quickly prove the effective functional performance of the system and to assist in validating the software for use within your facility. The package includes installation qualification (IQ) and operation qualification (OQ) procedures and forms to enable you to record all details needed to demonstrate that the system is working properly. This validation process provides assurance that the system has a high level of integrity and the data is accurate and reliable.
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We already have an automated humidity and temperature control system for our process that can also record data. Why then would I need to use a separate data logging system?
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Properly validating a process requires objective evidence and a common practice in the industry to obtain this evidence is through redundancy. This means that if there is an automation system controlling a process and a logger monitoring the process, independent sensing systems must be used. For example, if one system is controlling the humidity in a room, a completely independent system should be recording it.
Control and recording systems that operate without redundancy can appear to work satisfactorily but may, in fact, be operating well outside of specifications. Redundancy provides an objective double-check of system performance and, additionally, makes it obvious if either the controller or the logger is out of calibration.
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Frequently Asked Questions 