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LabWare - Guide to QC Laboratory Compliance

The document outlines the importance of quality control (QC) in laboratory management, highlighting the risks associated with paper-based data tracking, such as data loss and inaccuracies. It emphasizes the benefits of implementing Laboratory Information Management Systems (LIMS) and automation to enhance data management, compliance, and overall lab efficiency. Additionally, it discusses key performance indicators (KPIs) that lab managers should track to improve team performance and laboratory outcomes.

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tusitta
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© © All Rights Reserved
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0% found this document useful (0 votes)
5 views

LabWare - Guide to QC Laboratory Compliance

The document outlines the importance of quality control (QC) in laboratory management, highlighting the risks associated with paper-based data tracking, such as data loss and inaccuracies. It emphasizes the benefits of implementing Laboratory Information Management Systems (LIMS) and automation to enhance data management, compliance, and overall lab efficiency. Additionally, it discusses key performance indicators (KPIs) that lab managers should track to improve team performance and laboratory outcomes.

Uploaded by

tusitta
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 33

GUIDE TO

QC Laboratory
Compliance
Table of Contents

The Risks of Using Paper to Track Laboratory Data ................................................ 3

Why is Quality Control the Key to Effective


Laboratory Management? ....................................................................................... 6

4 KPIs Lab Managers Should Track ........................................................................... 12

How Automation Helps Quality Control .................................................................. 17

How LIMS Helps Drive Compliance .......................................................................... 20

10 Ways that QC Lab Managers Can Use LIMS ...................................................... 24

Benefits of a QC LIMS for Remote Lab Work ........................................................... 30

About LabWare .......................................................................................................... 33

Guide to QC Laboratory Compliance 2


The Risks of Using Paper
to Track Laboratory Data

Prior to the digital age, lab data was logged into notebooks that were then locked
away in fire-proof safes to protect them from physical damage. This system worked
on one condition: scientists, laboratory technicians, and managers wouldn’t lose
their notes and remembered to store their notebooks. Ultimately, paper systems are
difficult to manage and create risk from generating accurate results as it relies on
making no human errors.

There are significant risks that come with reliance on a paper-based


laboratory system:

Loss of essential data: Paper-based logs lack the ability to share the
data, easily retrieve it, or easily archive it. When the data does become
lost, scientists are required to repeat the experiments, even after a
certificate of compliance has already been issued. Having to repeat an
experiment can come at a high monetary and labor cost.

Inaccurate reporting: It’s often difficult to review historical data in


a paper-based system—it can be challenging to determine if the
data has been compromised or if the data set is complete. In highly
regulated industries, the lack of comprehensive and accurate reporting
can be detrimental to the lab’s overall success.

Guide to QC Laboratory Compliance 3


Difficulty storing data: Notebooks stored in a fire-proof safe are kept for
long periods of time, waiting to be archived. If your lab has a process to
manually scan and archive data in a local computer, that machine is
still at risk for damage with no backup.

Illegible note-taking: Paper files can be hard to read or even


completely illegible. Handwriting can be unclear to read or difficult to
understand if the scientist is prone to using shorthand that the reader
may not be aware of.

Difficulty to manage: Manual maintenance of your lab’s chain of


custody with a paper-based system can create cumbersome and
error-prone documentation, particularly when the lab grows and the
amount of documentation expands. The maintenance of this data
itself can become burdensome for a testing environment, which could
compromise the accuracy of your data.

Likely to fail an audit: One common reason for failing an audit is the
inability to provide the proof needed to substantiate a claim. For
example, manufacturing environments often need to prove sterility
across the entire environment. Paper-based documentation can be
difficult to track the entire process, and one misplaced document can
throw your lab out of compliance.

Guide to QC Laboratory Compliance 4


With all of these risks, why do labs continue to use paper-based data logging?
Lab managers often believe the costs of implementing a cloud-based LIMS can
be too costly for their lab. But what they tend to forget are the hidden costs
associated with misplaced notebooks, lost paper files, or the ongoing costs of
archiving and storing the paper records.

It bears repeating: The cost of not implementing LIMS technology is not zero.
Hours of time can be lost repeating work that has already been completed or
when results can’t be easily retrieved or verified. You’ll accrue additional costs
to hire a specialist archivist to ensure correct archiving of all paper-based logs.
This process often requires extensive indexing and cross-referencing.

Ultimately, laboratory managers also must factor in the cost of inefficiencies


and a lack of quality outcomes. With a paper-based system, you put your
laboratory’s reputation at risk, along with the fallout should products be released
that are, at best, low quality, and at worst, dangerous to consumers.

8 Major Risks of
Paper-Based
Laboratory Data

Learn More

Guide to QC Laboratory Compliance 5


Why is Quality Control the
Key to Effective Laboratory
Management?

A laboratory’s culture is critical to its success because it can drive how receptive
the team is to adherence. How can laboratories be managed effectively? As a lab
manager, you can follow these best practices:

Trust Your Team With Autonomy


Train your team members so they have confidence in their day-to-day activities.
This can help build team morale and understanding of the process, structure, and a
sense of responsibility.

The lab must work together as a cohesive team in order to maintain quality and
performance. Individuals are responsible for executing the work but will need to rely
on other team members for review.

Guide to QC Laboratory Compliance 6


Implementing a LIMS can store data on sample storage and quality assurance
results and give access only to authorized team members, even if they are working
remotely. This provides maximum flexibility for individuals to complete their work,
which improves quality and efficiency.

You should also use team incentives carefully in a way that promotes the greater
good of the laboratory team. The goal is to improve processes in a way that
empowers your team as a whole as opposed to simply focusing on increased
individual throughput.

You should also use team incentives


carefully in a way that promotes the
greater good of the laboratory team.

Guide to QC Laboratory Compliance 7


Measure Team’s Data for
Healthy Team Growth
Measuring your team’s success is important
not only to quantify the work done but to
also display the distribution of workload for
your individual team members and the team
as a whole. The ability to have a system
that can share team data and also keep
individual data private builds healthy internal
competition. It’s also important to choose
appropriate key performance indicators
(KPIs) that encourage team morale instead of
those that promote a toxic work environment.
Focus on team-driven metrics united under a
common goal instead of throughput metrics.

Additionally, be cautious of choosing KPIs that


could be artificially inflated by your team.
For example, if you spend time measuring
occurrences of investigations, it could focus
on individual work, even if other factors cause
the investigations, such as faulty equipment.
A lab member, in fear of an investigation,
may inaccurately document issues. This
faulty metric could put the lab can under an
audit. It’s ideal to focus on KPIs that improve
performance so that your team is motivated
to stay positive. Effective lab management
helps motivate lab members as a team and
encourages transparency among the team
so that they can help each other grow, rather
than work against each other.

Guide to QC Laboratory Compliance 8


Measure Key Performance Indicators
You can use your lab system to track data, which can also give your lab insight into
efficiently providing accurate and precise, high-quality results.

Data helps eliminate bottlenecks and errors to improve the lab’s quality and
efficiency performance. To do so, you’ll need to first establish the priority of goals
and the data utilized. As a lab manager, you should set KPIs that will serve as
benchmarks for your team.

What KPIs should you set? That depends on your lab’s specific environment,
its needs, and the problem you help solve. Consider these questions when
determining your KPIs:

1 2 3
What should we Are these objectives Do these KPIs
measure so that the attainable and encourage only
team is motivated reasonably set? positive changes?
and encouraged to Could they motivate
perform at a high team members to
level? adopt poor behaviors?

Guide to QC Laboratory Compliance 9


Some common KPIs in laboratories include:

Backlog – Bring efficiency to your lab’s workload and task distribution. No


individual’s capacity should be overloaded, and that the laboratory is neither
overperforming nor underperforming. A simple graph of backlog data can reveal
potentially telling peaks and troughs.

Length of time – Understand the full time it takes for a batch of samples to be
released. This information can be documented by your LIMS, so you can develop
forecasts and maintain a commitment to your lab’s execution.

Right First Time – The concept of ensuring that a procedure is performed the
first time correctly and every time is referred to as First Time Right (FTR) and originates
from Six Sigma. What is the number of experiments or tests that get sent back for
review or correction? Labs are more efficient if the measurements and associated
documentation are following processes correctly the first time. FTR makes it easier
to see the patterns in the review process—and know exactly what needs to be
improved upon or changed.

Collecting data and visualizing it for the team gives you a transparent look into
what’s working and what needs optimization.

Guide to QC Laboratory Compliance 10


Create Visual Dashboards for Information
Building visual digital dashboards for your lab can show your team the progress
of their work at any point in time, as well as the trends of your established KPIs. You’ll
be able to pinpoint issues before they become significant problems.

You can use your LIMS to build dashboards since the data is centralized and
automates lab management monitoring of the progress of each sample’s lifecycle.
Using this information, lab managers can reallocate work within the LIMS as needed
to fill in gaps. Dashboards also track quality and efficiency metrics to identify
whether the lab is improving over time.

A good LIMS will enable lab managers to create their own dashboards that cover
the KPIs and lab management metrics that are key to their environment, as well as
change what’s being measured as focus moves from one area of improvement
to another.

6 Best Practices
for Effective
QC Laboratory
Management

Learn More

Guide to QC Laboratory Compliance 11


4 KPIs Lab Managers
Should Track

Lab Testing Overview


The lab testing dashboard helps the lab
manager to stay informed about daily
operations within the lab. It serves as a
snapshot of the lab’s status, including the
number of ongoing and completed tests,
the status of tests, and the tests that remain
to be done. LabWare’s lab testing overview
dashboard features easily digestible charts
that make it simple to obtain and process
relevant information.

The lab testing overview ultimately serves


to keep the lab manager well-informed on The lab testing
all operations, but the advantages are not dashboard
limited to one individual. Employees can
helps the lab
benefit from viewing this dashboard to stay
accountable. Analysts have the opportunity
manager to
to review what work has been assigned to stay informed
them and what still needs to be completed. about daily
In this way, individuals have a resource to operations
help them stay productive and supervisors
within the lab.
can stay up-to-date on the general workload.

Guide to QC Laboratory Compliance 12


Lot Management
The lot management dashboard presents
information about the lots of products
your lab processes. Conveniently review
the products your lab has finished, the
status of product development, and more.
This system also records the number of
samples received, analyzed, and those that
require review. Additionally, lab managers
can view the lot management dashboard
to see which lots are ready to be released.
Easy to navigate and understand, this
dashboard encourages efficient operations
within your lab. The lot
management
Similar to the lab testing overview
dashboard
dashboard, lab managers have the
freedom to select what data appears on
presents
the dashboard gauges and charts. Even information
better, managers can create new measures about the lots
based on almost any criteria and easily of products
change what the dashboard looks like. The
your lab
chosen gauges are linked to metrics that
processes.
measure the current state of your lab in real-
time. Of course, KPIs are specific to each
lab, so gauges are configurable based on
what metrics matter to you and your team.

Guide to QC Laboratory Compliance 13


Stability Management
LabWare’s stability management dashboard
LabWare’s
shows the status of active stability studies,
including details about each test the lab
stability
has undergone. Once again, metrics can management
be configured to meet the needs of the dashboard
user. Customizable graphs appear on the shows the
stability management dashboard and the
status of active
design status of various studies can be
reviewed, whether already approved or in
stability studies,
creation. Details of recent and future including
stability pulls are displayed to aid in the details about
planning of work and identify upcoming each test
peaks that may require additional effort,
the lab has
giving a customizable dashboard that gives
an instant view of actual stability work being
undergone.
planned and underway in one place.

Guide to QC Laboratory Compliance 14


Quality Oversight
The quality oversight dashboard gives
lab managers the flexibility to tailor the
dashboard to meet their needs. Among the
numerous capabilities of this dashboard,
users can review metrics and receive a
report that can be conveniently exported to
Excel. Equally useful is the ability to access a
detailed summary of a lab’s, department’s,
or entire organization’s current situation that
keeps managers at all levels informed in
real-time.

At the top of the quality oversight The quality


dashboard is a list of the KPIs that should oversight
be specific to the lab, department, or
dashboard
organization. Users will see a high-level
number in the table that is produced
gives lab
based on what it is an organization wants managers
to measure. The gauges on the right- the flexibility
hand side of the dashboard are useful to tailor the
visuals to quickly communicate the status
dashboard
of a metric. The acceptable (green)
to meet their
gauges and unacceptable (red) gauges
can be adjusted. Number placements
needs.
on the gauges can be customized to
accommodate cases where a higher digit
might indicate a less desirable outcome.

Guide to QC Laboratory Compliance 15


As with all the LabWare dashboards, the displayed values in the table, graphs,
and gauges are configurable on a per user basis, so a departmental head can
monitor what’s important at a higher level than a Lab Manager driving daily
operations. Different labs may decide on different metrics to represent their KPIs
and therefore have a dashboard that is meaningful to that lab. The configuration
and ease of measuring, displaying and ongoing monitoring of KPIs help
laboratories and organizations drive change and performance using real data.

Popular LabWare KPI


Learn More
Dashboards for Lab Managers

Guide to QC Laboratory Compliance 16


How Automation Helps
Quality Control

Automation can be a valuable component of a successful quality control program.


QC automation works best with successful preparation and a system to support it.
Remember - just because you can automate a process, it doesn’t mean that you
should. First, set your automation goals:

Understand the key aspects of your laboratory’s processes, including


how data is generated and where it is stored.

Determine which processes would benefit from using automation


- often, this means processes that are enforced, measured, or
evaluated. Often, these processes require manual checks to make
sure that the proper attributes were correctly entered.

Are you subject to audits of your results or metadata? Automation


can help ensure compliance around electronic data by
documenting every aspect of the data capture.

Automation can be a valuable


component of a successful quality
control program.

Guide to QC Laboratory Compliance 17


Which QC Processes Benefit From Automation?
Automating quality control processes starts with data entry. If you have a trusted
LIMS in place, you can use it for multiple automation needs:

Automatically log samples, perform tests, import results, and attach this data
to samples or other specified locations

Check specifications during result entry to validate the data to ensure it falls
within approved tolerances

Launch investigations if thresholds are triggered to identify the sources of


inadequate results.

Encourage better data entry with automated notifications for users to record
the right data

Log changes to comply with GMP by detailing every step and the reasons
behind any data entry changes

Perform environmental monitoring of samples to ensure that samples are


logged and retrieved according to the lab’s schedule. Automated prompts
can indicate readiness for sampling and that required testing needs to
be done.

Monitor sample stability to detect when changes occur, especially to identify


subtle trends over time. The LIMS can notify the lab when to pull samples from
particular chambers, which tests need to be performed on samples, when the
tests need to be performed, and where samples need to be tested.

Guide to QC Laboratory Compliance 18


The Importance of a QC Manager in
Laboratory Automation
The lab manager holds a high-level view of laboratory processes in order to
authorize any need to intervene. If you’re looking to implement QC laboratory
automation successfully, it will involve a hands-on approach from the lab manager.
Why? They need to first determine that correct metrics are in place to track
performance quality trends and understand where quality can be improved.

There needs to be a balance between the need for automation with the need for
manual processes - both must work together to provide the best quality product.
After all, the most rigorous process with the best quality and efficiency outcomes
is achieved through a marriage of manual processes and LIMS automation; this
approach is particularly important to avoid heavy customization or inefficient
manual interactions.

Overall, the manager’s perspective gives them authority to redesign processes with
people, instruments. Understanding the different capabilities that a LIMS provides,
the lab manager can optimize for these elements - the lab makes sure that every
lab sample is reviewed and checked for quality and those quality standards are
enforced across all workflows.

An efficient lab manager that leverages the power of LIMS automation when
appropriate can help save the lab time and resources, intervene prior to human
error, and enforce quality performance.

Guide to QC Laboratory Compliance 19


How LIMS Helps Drive
Compliance

Your lab can use a LIMS to help drive laboratory compliance with regulations and
best practices. There are three areas where using a system can assist:

Organization in your laboratory identifies which best practices may be


carried out using a LIMS. Data should be standardized and collected by
defining and configuring the required and desired parameters so that
your labs can use the LIMS to record data consistently over time. Your
lab will need to maintain accurate records of the chain of custody—
from sample receipt through storage, testing, and disposal. A LIMS helps
eliminate the confusion and error-prone ways to manual documentation
by attaching barcodes for individual samples to provide better
accuracy, consistency, and accountability.

Guide to QC Laboratory Compliance 20


Visualization helps lab managers and the overall team report on sample
testing and usage, ultimately to recommend optimizations. The ability
to collect electronic data helps document visible trends that can be
used to improve lab operations or intercept compliance issues before
an audit. Compliance data is visible and transparent for all users, so
everyone in the lab can view the information they need to ensure
compliance with best practices. The visualizations can also track KPIs to
show progress and opportunities for improvement within the lab.

Automation helps remove human error and provides additional


capabilities for documentation. With a LIMS, your lab can capture
more details than could be captured manually—and the data is more
accurate, especially if the LIMS is integrated with lab instruments and
software. A quality LIMS can also notify the manager of any items that
fail specifications so that they cannot be released without further review.

Using LIMS for automation and organization allows the lab to enforce a comprehensive,
accurate audit trail for all samples and their results.

Guide to QC Laboratory Compliance 21


How LabWare LIMS Helps With
Compliance Regulations
LabWare LIMS is designed with best practices and principles determined by GLP,
GALP, cGMP, and ISO 9001:2000, as well as the FDA and MHRA Data Integrity
guidelines. With LabWare, your lab is able to:

Allow for centrally managed configurations instead of intricate customizations

Conduct audits for configuration changes and modifications of raw data

Provide room for configurations and language translations without altering the
source code

Conform to “Closed System” requirements per FDA 21 CFR Part 11;

Conform to GAMP 5 Guidelines per “Category 4 – Configurable Software


Package.”

The LabWare LIMS follows standard operating procedures (SOPs), including thorough
documentation of all software changes. As a vendor, LabWare also has an internal
ISO-trained auditor who regularly reviews all documentation to ensure compliance
with best practices. LabWare customers also take it upon themselves to closely
scrutinize the product to see whether it meets their compliance needs, providing
valuable input that is used to further reinforce best practices.

The LabWare LIMS follows standard


operating procedures (SOPs), including
thorough documentation of all software
changes.

Guide to QC Laboratory Compliance 22


All laboratories must have a way to document data and track any changes,
including who initiated them and when they were performed to prevent errors
and fraud. LIMS software effectively acts as a third party, providing objective
documentation of these changes. LabWare’s LIMS is designed to satisfy all of
the components of ALCOA+ (Attributable, Legible, Contemporaneous, Original,
Accurate, Complete, Consistent, Enduring, Available), core principles designed
to ensure data integrity.

Lab managers can review how LabWare’s validated workflows operate within
their laboratory’s specific processes. Many labs adopt the validation packages
with no changes, though others augment it with laboratory-specific validation
specific to their uses and applications. Whether a laboratory decides to add
onto the existing validation with additional measures, LabWare delivers a robust
solution that has a proven history of successful laboratory implementation
and audits.

How QC Lab
Managers Use
LIMS to Solve
Quality Issues

Learn More

Guide to QC Laboratory Compliance 23


10 Ways that QC Lab
Managers Can Use LIMS

How do quality control lab managers use LIMS to their best advantage?

Sample Tracking
The right systems need to be in place to track the samples being tested, the
assignments of those samples to scientists, and the specific attributes to be tested.
It is also important to make sure that automatic systems are implemented to
maintain sample testing timelines and ensure that the right testing is performed
and completed on time. Ideally, the results of any tests are stored alongside
the samples.

These details need to be documented in a manner that can be easily presented


during an audit to demonstrate laboratory compliance.

Guide to QC Laboratory Compliance 24


Chain of Custody
A LIMS solution can track where the sample
is, how stable its storage is, and monitor any
work that has begun on it. If the sample
moves from one lab to another, automatic
tracking through the LIMS can help keep
documentation smooth and simple. When
working with higher-risk samples, such as toxic
chemicals or biohazards, LIMS can keep track
of whether they have been properly disposed
of and how the disposal occurred.

Lot Release
Quality control is a critical part of a larger
chain of production in many industries. As
such, it is vital that any lot of a released
product must meet strict specifications. Good
Manufacturing Practice (GMP) requires
manufacturers to assure that their products
are consistently high quality, from lot to lot,
and specify that the manufacturer must
maintain proper documentation and records.
Testing results need to be tied to each sample
and detailed and accurate documentation
must be readily available, all of which can be
handled efficiently through your LIMS.

Guide to QC Laboratory Compliance 25


Traceability
Sometimes things go awry in pharmaceutical
production and the final end product fails
to meet specifications, resulting in quality
investigations—or worse, product recalls.
Having the ability to trace product history
through production, storage, and handling
can pinpoint problems—or support the need
to look elsewhere to find the issue. Because
LIMS automatically tracks these properties
of samples, traceability is intrinsic to the
laboratory workflow.

Investigations into
Atypical Results
It’s not only laboratory audits that benefit
from the documentation afforded by the
quality control capabilities of a LIMS. If
the results generated from testing include
something atypical, the LIMS can help
investigate why that particular result
occurred, perform additional testing to
determine if it’s a singular batch issue or a
larger laboratory issue.

The investigation efforts can be documented


and stored as part of the sample’s history for
future reference, whether for applications
or for audits. Capturing deviations allows a
QC lab manager to take action and address
issues prior to batches failing specification.

Guide to QC Laboratory Compliance 26


Identify Trends
LIMS implementations can track and analyze the historical data stored in the
system, which helps lab managers identify trends over time.

If there are any recurring issues involving samples, having access to these time
trends can help pinpoint the source of problems. Problems can range from supplier
issues, human error, instrument malfunctions, or inconsistencies in hardware. Tracking
data over time does not just improve quality in the moment, but it also allows
access to trends that can anticipate future issues. QC lab managers can respond
by taking more holistic corrective actions to positively influence laboratory quality.

Results Entry
The sample data that a LIMS records are immediately compared against the
expected specifications. This immediately highlights if unexpected or undesirable
results have emerged. In turn, the laboratory can leverage this built-in LIMS quality
control to immediately respond to the problem.

Due diligence and investigations on samples are easier to carry out effectively
when they happen practically in real-time, as opposed to the weeks of lag that
can result in a best-case scenario with manual documentation. LIMS allows you to
enter in the ranges of acceptable values for testing results so that any intolerances
around the specifications or warning limits can flag potential issues as soon as you
input the sample result.

Guide to QC Laboratory Compliance 27


Data on Instrumentation
The fact that a LIMS automatically captures data electronically from laboratory
instruments allows for more timely data entry at regular time points, and to
greater levels of detail as opposed to manual documentation. By eliminating
human transcription, errors are avoided, additional checks are reduced, and
associated metadata can be captured immediately.

A LIMS implementation removes much of the potential for error. When your staff
needs to examine the record later, the human error associated with it can be
eliminated. Instead, the manager or lab member tracking down any issues,
errors, or deviations can focus on instrument calibration or other characteristics
of instrument operations and laboratory protocols to identify the source of
the problems.

Guide to QC Laboratory Compliance 28


Instrument Calibration
LIMS quality control features can even empower a laboratory to develop a
managed process for monitoring calibrations and ensuring laboratory-wide
precision. This also incorporates a checkpoint where instruments cannot be used
until they meet calibration requirements defined in the system. An uncalibrated
machine can introduce extensive errors downstream or disqualify results that have
been generated.

Assists Overburdened Lab Staff


Not using LIMS quality control features leaves documentation and tracking in the
hands of humans who are prone to error, even in the best laboratories. Every lab
member will experience stress at some point, which negatively impacts their work
overall. Under stress, people tend to be more forgetful, prone to mistakes, and may
even deliberately cut corners even if they know they technically should not. The last
thing you want is to fail an audit, particularly for something that’s easily preventable
through automation and built-in controls.

Another aspect of how LIMS quality control interacts with an overburdened lab
staff is through monitoring for problems. If major or consistent sample issues are
detected, you may effectively end up with direct measurement of your laboratory’s
capacity. Without measurement, it can be difficult to understand their scope or
see how overworked they are. You may just think your lab is very busy when some
of your staff are actually overworked. Looking at the sample trends automatically
documented in LIMS can shed light on this.

Best Practices for QC


Learn More
Laboratory Automation

Guide to QC Laboratory Compliance 29


Benefits of a QC LIMS for
Remote Lab Work

By utilizing the capabilities of cloud technology, many laboratories are


embracing the ability to conduct lab work across multiple locations—effectively
expanding their working hours around the clock.

What are the benefits of utilizing multiple locations for work?

Faster Review: Experiment review can be handled by centralized teams that do


not have to be in the same location as the scientists. Staff located in the United States
can review experiments conducted in the United Kingdom to minimize the data
turnaround time for critical activities such as responses to regulatory agencies.

Recruiting Opportunities: Your organization is not limited by geography to


attract the best talent. Working remotely can also be a benefit: Employees that
work remotely full-time are reported to be 22 percent happier with better work-life
balance, less stress, and more productivity.

Cost Savings: Using remote staff can help reduce infrastructure costs if many of
your staff do not need to come into an actual lab.

Resource Agility: You can adjust your lab’s contract work based on demand.
When there is additional demand, you can look to scale your operations and use
contract staff instead of hiring full-time employees.

Guide to QC Laboratory Compliance 30


You can even use a cloud-based LIMS
to access your lab data and manage a
significant amount of lab processes, such as:

• Complete experiment write-ups


• Release batches
• Create stability programs
• View lab data and generate reports
• Conduct experiment or stability time point
reviews
• Answer data queries
• View, trend, and analyze product data
• Generate data for regulatory dossiers

A cloud-based LIMS provides access to data


digitally regardless of the team’s location.
This accessibility helps build resilience in the
lab. Without the ability to analyze data and
generate reports off-site means that your
lab is effectively shut down. Smaller labs that
have relied strictly on manual documentation
are at perpetual risk of losing their data.

A cloud-based LIMS provides access to


data digitally regardless of the team’s
location. This accessibility helps build
resilience in the lab.

Guide to QC Laboratory Compliance 31


Generate Success with a Remote
Lab Environment
It’s important to understand that a remote lab environment differs from a physical
lab, so it requires an environment that supports remote work to result in increased
productivity and collaboration.

Here are some ways to set up your remote lab for success:

Have reliable and secure access to lab data, meaning installing high-speed
Internet connectivity with secure devices that have proper protocols for
protection, including personal mobile devices.

Encourage a team atmosphere that is more cooperative instead of


competitive. Because there is a lack of in-person interaction, your lab should
make it a priority to support remote staff and ensure they’re part of the team.
This includes:

• Regularly scheduled meetings and check-ins


• Using video conferencing to build face-to-face time
• Encouraging personal connections, not just work-related talk
• Being available to answer questions during your remote employees’
working hours

How Laboratories
Can Take Advantage
of Remote Work
Environments

Learn More

Guide to QC Laboratory Compliance 32


About LabWare

For more than 30 years, LabWare has been the worldwide leader in software
for automating laboratory operations. Laboratories in diverse industries have
modernized their operations and processes, using LabWare LIMS (Laboratory
Information Management System) and ELN (Electronic Laboratory Notebook)
to electronically document experiments, track and manage samples, perform
environmental monitoring, manage stability studies, and more.

Founded by CEO Vance Kershner in 1987, LabWare has offices in 25 countries,


employees in more than 50 countries, and customers in over 125 countries.

In recent decades, dozens of commercial LIMS applications have hit the


market, most offering limited functionality or focused on narrow applications.
No lab informatics company has worked across the globe building and
deploying solutions for Fortune 500 companies like LabWare.

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