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Isabel joined Technology Networks in June 2024 as a Science Writer and Editor after completing her PhD in human physiology from the University of Nottingham. Her research focused on the importance of dietary protein and exercise in maximizing muscle health in advancing age. She also holds a BSc in exercise and sport sciences from the University of Exeter and an MRes in medicine and health from the University of Nottingham.
Molly Coddington is a Senior Writer and Newsroom Team Lead at Technology Networks. She holds a first-class honors degree in neuroscience. In 2021 Molly was shortlisted for the Women in Journalism Georgina Henry Award.
Data powers scientific discovery and directs new areas of research. The integrity of such data is of vital importance but has not always been at the forefront of processes within laboratories and organizations.
Download this infographic to learn more about:
What data compliance is and why it is important
Differing data compliance regulations
How technologies can simplify the compliance process
DATA
COMPLIANCE
RA
LABORATORY
Data powers scientific discovery and directs new areas of
research. The integrity of such data is of vital importance but
has not always been at the forefront of processes within
laboratories and organizations.
In this infographic, we explore the importance of data
compliance and how laboratories and organizations can
employ technologies to simplify compliance processes.
What is data
compliance?
Data compliance is the practice of
making sure your laboratory or
organization follows regulations to ensure
What is
that data is safeguarded against loss, theft,
corruption or misuse.
metadata?
Compared to data security, data
compliance is the minimum legal
requirement to safeguard data within
laboratories and organizations.
Metadata are data that
provide information
about other data.
What is temporary
memory?
For example, when measuring muscle tissue weights,
you are collecting data. When you also record your
name and the date/time of these measurements, these
data are called metadata.
Temporary memory is
data entered into a
server or database
before saving it to a
permanent memory. As
these data are at risk of
Metadata is essential for data compliance as it allows
amendment or deletion
for discovery, access and assists with auditing.
without audit trail
Therefore, the relationship between data and their
visibility, temporary
metadata should be preserved in a secure and
memory usage should
traceable manner.
be minimized.
Why is data compliance important?
Data compliance is crucial to a
research organization’s reputation.
If data is found to be put at risk or
exposed to fraudulent activity, the
A laboratory scandal highlighted
laboratory’s reputation may be
clear loopholes in data regulation and
ruined. Failing to comply with data
emphasized the importance of
compliance may lead to funding
improving data compliance for
from external bodies being pulled,
scientific development. Issues such
legal action, financial penalties and
as changed chromatograph data and
a potential prison sentence.
failed quality control experiments
were missed due to the use of paper
records and not electronic records.
In the early
Times are changing, with electronic
2000s…
data compliance a the top priority of
regulators such as Food and Drug
Administration (FDA) in the US and
the European Medicines Agency
(EMA) in Europe.
Data compliance regulations
FDA Title 21 Code of Federal
Regulations (CFR) Part 11
The FDA’s standard for the management of
electronic records that are created, maintained,
retrieved or transmitted. This is the required
standard for correct data management.
Medicines and Healthcare
products Regulatory Agency
(MHRA): Good Practice (GxP)
Provides guidance on the data integrity
expectations for organizations involved in any
aspect of the pharmaceutical lifestyle or good
laboratory practice studies regulated by MHRA.
European Union Good
Manufacturing Practice (GMP)
Volume 4, Annex 1
Guidance for the interpretation of the principles and
guidelines of GMP for medicinal products for
human and veterinary use. Annex 1 provides
specific guidance on the manufacture of sterile
medicinal products.
FDA Data Integrity and
Compliance With cGMP
The purpose of the guidance is to clarify the role of
data integrity in cGMP for drugs.
The World Health Organization
(WHO) Good Data and Record
Management Practices
Provides information, guidance and
recommendations to strengthen data integrity in
support of product quality, safety and efficacy
Are data compliance
guidelines being met?
Between March 2018 and September 2019, less than half of 4,209 clinical
trials published their results to the FDA within the mandated 1 year of
completion. Only 1,722 trials submitted results on time and in compliance
with the law, meaning 2,487 trials breached it.
Industry sponsors were more likely to report results and have the
highest levels of compliance, compared to non-industry, non-US
government sponsors.
These data compliance violations have led to numerous regulatory actions,
including warning letters, import alerts and consent decrees. Further, failing
to report results to the FDA can bring fines to a responsible party.
Automation and
•
Removes human error from workflows
digitalization:
•
Processes can become automated using
laboratory execution systems.
Audit trails:
How can data
Audit trails tell you what was done,
compliance be
when, why and by whom. This gives
improved and
confidence that your laboratory is
simplified?
following strict guidelines and
protocols correctly to achieve data
compliance.
•
The breadcrumbs along the
research trail.
•
Crucial for inspections, allowing
the investigators to review all
data, processes and procedures.
Laboratory
information
management
Electronic
system (LIMS):
laboratory
notebooks
(ELNs):
•
A sophisticated software used to manage
samples and store all associated data
LIMS can:
•
•
A digital replacement for paper
.
Build in audit trails
based
laboratory notebooks
.
Limit tests to only approved
•
Controlled user access to ensure
equipment
data security
.
Force users to respect standard
•
Emphasizes the importance
operating procedures (SOPs)
of electronic signatures
during testing
•
Emphasizes the importance of
•
If optimized for use, LIMS can lead to
audit trails.
huge increases in efficiency, reliability
and productivity.
Sponsored by
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