EUROLAB “Cook Book” – Doc No.

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Technical records

Introduction
The increasing use of computers and computer systems in laboratories has led to an
increased number of electronic records. There are a lot of advantages of electronic records,
e.g. no need for a physical space for an archive, good posibilities to search for records, etc.
Most laboratories have electronic records, even though a lot of physical records are being
kept. However, many laboratories do not know exactly how to handle electronic records. The
standard ISO/IEC 17025:2017 has some requirements as to how a laboratory should
generally handle record keeping, and of course these requirements also apply to electronic
records.

Procedures for technical records

ISO/IEC 17025:2017 clause 7.5 covers all kinds of technical records related to each
laboratory activity. Records are therefore not only related to an analytical value, but also to
all information and parameters that could affect results and/or activity repetition. This could
include:
- Environmental conditions
- Personnel name
- Date and time of activity
- Information about used instruments/tools
- Reagents and materials
- Calibrations
- Details of set up
- Conditions of test sample
- Sampling conditions
- Raw data
- …

Of course, the requirements of ISO/IEC 17025:2017 apply to both handwritten and electronic
records.
For handwritten records, it is necessary to maintain a clear and appropriate set of
documentation that the laboratory decides to implement in its Management System (Lab. log,
Diary, Project note, …). This type of paper documentation is usually stored in a project folder
along with all other project documents (quotation, contract, report, …).
In addition to raw data or measurements results, any type of handwritten
agreement/modification made in a document for a particular project may be considered
“technical data”.
For electronic records, the requirement is fulfilled by documenting in the management
system how the files are named, where the records are filed and stored (which server,
networks, electronic folders etc.), and the personnel having access to the storage locations,
both physically and electronically.
Electronic records are also mail messages containing information, agreements, decisions or
any other kind of information related to the laboratory activity.

In the circumstances referred to above, a “laboratory management system” is to be

understood as the set of rules that the laboratory defines and implements for the
management of information and technical data; “laboratory management system” is not to be
understood as a computer program or application.
In order to keep the records under control, a laboratory should develop a set of templates for
the electronic records it is producing and protect the templates from inadvertent changes by
the staff. A defined template, such as a check-list or a fixed-fields table, is usually a good

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reminder to record all necessary information and minimize the possibility of staff making
mistakes.

Storage of technical records

Technical records must be retained for a certain period of time, as defined by national
legislation, accreditation rules, contractual agreements; this is usually a long-term period
running from 3 to more than 10 years.
It’s therefore mandatory to implement specific measures in order to safely store data and
prevent data loss.
Paper records are usually not influenced by long term retention time providing the
environmental conditions in the storage area are adequate; temperature and humidity of the
storage area might be evaluated and periodically checked.
Thermal printing (chemical paper) has a limited life-time running from few days to some
weeks, mainly depending on ambient temperature or contact with chemical solvent (glue,
adhesive tape). This kind of support cannot be stored “as is” and must be transferred to other
kind of physical support (copy or scan) for long-term retention.
Electronic devices (e.g. memory sticks, hard disks, CDs) for data storage have limited life-
time. When using cloud storage, specific agreements with the provider (e.g. lifetime, access,
data security, transfer and integrity, confidentiality) are suggested. Use of this kind of
electronic support only for short-term storage or transfer of data providing a dedicated means
is implemented in order to guarantee data integrity/readability after transfer of data to other
kind of support.
Proprietary data format, usually identified by a proprietary extension of files, is also an issue
in case the original software/application/instrument is dismissed during the retention time and
no other “data reader” or “data converter” is available.
Data stored on a “data server” are usually safe, providing some basic IT principles are
respected:

- the server used for storage is placed in a facility with limited physical and electronic
access (locked room, firewall and password),
- the climate is controlled,
- the requirements for avoiding damage or deterioration and for preventing losses are
fulfilled,
- Backups are regularly performed on a different remote support (may be a remote
server, a tape stored in another building, a cloud server, …).

This should of course be described in an MS documentation. In addition, the issue of fire

protection and the need for burglary and fire alarms should be considered.

If the laboratory uses mobile devices for data recording, it is recommended to regularly move
the data to servers.

Retention time of electronic records

Another issue of importance is the format for storing the information. Due to the very rapid
technical development in the IT sector, there is a risk that data stored in a specific format,
e.g. a special format associated with a measurement programme, may even not be readable
before the retention time has expired. The best way to avoid such problems is to store the
records in a format that is likely to last for a long time, e.g. in text format or for recorded data
in commercial formats. These formats will survive for a long time and if they disappear it will
be well known in advance and commercial solutions to the “retrieval problem” will be
available. The laboratory might include the chosen solution (which format) in the
management system.

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The management system could also establish a reasonable retention time (in accordance
with national legislation, contractual agreements, accreditation rules, etc.) and whether and
how records should be deleted/disposed of or what should be done if the retention time has
expired.

Raw data

Handwritten raw data could be stored in the specific project folder, taking into account the
above storage provisions.
For the laboratory that uses electronic records, this requirement is fulfilled by storing original
observations (data taken from the analytical instruments) and/or derived data in digital
format. An electronic record can also be a photo or a movie; in this case, the digital
“metadata” could be saved together with the file, if available, or otherwise integrated, so that
the record can be related to the specific activity. A good way to store records connected to a
project is to place them in an electronic folder.

There is no need to keep the information in its original format as long as you can access it
during the retention time and ensure its integrity.

The calibration certificates for the equipment used and the staff records are usually not
stored in the same electronic folder as the rest of the information on the assignment, and it is
therefore important to refer to the equipment used and the staff that performed the
assignment, preferably in the test report.

The retention time of the records to depends on various aspects. There may be requirements
on the part of the authorities to retain records for 30 years or for eternity. Normally, however,
the retention time should be determined by the laboratory itself. The retention time is usually
at least 3 years and in most cases 10 years.

Identification of data
Paragraph 7.5.1 requires that “the technical records shall include the date and identity of
personnel responsible for each laboratory activity and for checking data and results. Original
observations, data and calculations shall be recorded at the time they are made and shall be
identifiable with the specific task.” As already stated above, the use of the identification of the
assignment/order fulfils this requirement.

Amendments to technical records

While amendments to handwritten records are achieved by simply strikethrough the original
text, writing the new text with signature (by authorized personnel) and date, the same
amendments to digital records may be difficult to handle for some types of electronic records.
For complete documents, the “revision” option, which is available for many text editors or
spreadsheets, is an opportunity, provided the original file is maintained and both files have
the appropriate revision index.
Typically, these types of files are stored along with a set of data related to the user and to the
last save or modification; this data is usually visible under the “File Property” command.
In this case, both “public information” (revision index and date) and “private information” (file
properties) are available to track back to the original information.

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Some software, such as LIMS or mainframes applications, keep track of what was changed
when and by whom, but this type of applications is not typically used for raw data.
The output of digital/automated instruments or measuring systems generally requires no
amendments; in case a setup or a parameter was incorrect during the test execution, the test
is repeated. In that case, it might be useful to take note of the mistake and save both files; it
could be an indication of a preventive action.
The main issue relates to analytical values that are entered by the operator in a file
(spreadsheet or text editor). In this case, it is not possible to simply write the correct value
and save the file again. The original data is completely lost forever!!!
One of the option is to:
- copy and rename the original file to uniquely identify the wrong file,
- open the copy of the wrong file (the original copy is therefore protected from an
erroneously “save” command),
- strikethrough the original text, as per handwritten data, write the new text, and save
the file.
- In most of the cases you can have a lot of options to identify the amended data and
the amendment’s executor: remarks on text files, highlighting, coloured text, notes, …
but, of course, also other procedures can fulfil the requirement.

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