Validatable Data Logging System

Frequently Asked Questions

Does this system provide GMP-compliant records?

How do the FDA CFR 21 Part 11 requirements relate to the VL-series system?

What is meant by the terms "validation" and "validatable"?

Secure data logger files: What are they and why are they important?

Has the FDA approved your VL-series data loggers?

Do you provide any assistance to validate this system for our facility?
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?

General questions about Veriteq data loggers.

Does this system produce GMP-compliant records?

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 GMPcompliant 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.
How do the FDA CFR 21 Part 11 requirements relate to the VL-series system?
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.
CFR 21 Part 11 Requirement
Reference
VL-Series Features
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.
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 password-protected and encrypted electronic records that are
used to produce printed documentation
Software recognizes invalid or altered data logger files and renders them unusable
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
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
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
What is meant by the terms "validation" and "validatable"?
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:

i.
ii.
iii.

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.

Secure data logger files: What are they and why are they important?
Secure data logger files are tamper-proof files created using vLog Software from a VLseries 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.
Has the FDA approved your data loggers?
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.
Do you provide any assistance to validate this system for our facility?

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.
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?
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.