LabWare - Guide to QC Laboratory Compliance
LabWare - Guide to QC Laboratory Compliance
QC Laboratory
Compliance
Table of Contents
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.
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.
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.
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.
8 Major Risks of
Paper-Based
Laboratory Data
Learn More
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:
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.
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.
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?
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.
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
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
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
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.
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:
Using LIMS for automation and organization allows the lab to enforce a comprehensive,
accurate audit trail for all samples and their results.
Provide room for configurations and language translations without altering the
source code
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
How Laboratories
Can Take Advantage
of Remote Work
Environments
Learn More
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.
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