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Insights and key facts
Bioassay management explained by experts.
Discover concise information on PLA 3.0 and related bioassay management topics. Get quick, reliable answers to keep you informed and focused on what matters.
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End-to-end bioassay management
Analysis. Operation. Development. Administration.
Insights into PLA 3.0 as your software for managing your bioassay needs.
Data analysis
Take control of your assay data with PLA 3.0. Achieve accurate, consistent, and compliant results with powerful analysis tools tailored for biological assays.
Method development
Optimize your assay workflows with PLA 3.0. Develop, refine, and validate analytical methods that ensure accuracy, reproducibility, and regulatory compliance.
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From A to Z
Explore the many layers of PLA 3.0
Read up on the key terms and concepts in our Knowledge Center—each letter links to a detailed topic.
A
Add-ons
PLA
3.0 add-ons extend the functionality of the framework to include the
analytical methods your users require and enable them to visualize, document,
and report results.
B
Basic bioassay protocol
Lets you combine the results of multiple independent
assay runs into reportable values. Organize complex methods, retest scenarios, and report
several products in a single assay.
C
Confidentiality
Data confidentiality ensures that data is protected from
unauthorized access and disclosure, and that personal privacy and proprietary
information is protected.
D
Documents
PLA 3.0 securely stores all your data within electronic
documents. Your data remains complete, accurate, and
consistent throughout its life cycle, thus ensuring data integrity.
E
Equivalence margin development
Lets you utilize data of historic assays to
develop and verify test systems and use these systems to apply them in new assay
development.
F
Framework
The PLA 3.0 framework is responsible for the integrity and reliability of measurement data. It provides the features you need to achieve regulatory compliance such as access control, data integrity, security, validation, and traceability.
I
I-Chart
I-Charts monitor data such as measurements and regression parameters at regular
intervals, with each data point within the chart representing a sample or an
observation respectively.
All charts generated by the Control Chart Package are I-Charts.
N
Navigator
The
Navigator on the left side of the PLA 3.0 main window is your main tool for accessing
and organizing your documents and folders.
O
Observation group ID
Each
assay element has a unique observation group ID assigned, linking the assay
element to its respective observation data in the data editors. To switch plate
positions for your samples, simply reassign the respective assay elements to a
different observation group ID.
P
Preparation schemes
Preparation
schemes are your central tool for efficiently assigning settings to assay
elements. Define doses and dimensions of your treatments once and use the setup
for as many assay elements as you require. Entering redundant information is
not necessary.
Q
Quantitative response assays
Let you calculate relative potencies of Test
samples compared to a Standard sample. If you provide information on the stock solutions or
raw materials, you can also determine absolute potencies based on several types of
calculations.
R
Response data processing
Use
response data processing to configure the processing of response data, for
example, to subtract the absorbance of blank wells or to divide response values
by the mean absorbance of maximum binding wells.
S
Security contexts
Let you implement your permission system
and control who can perform which tasks on documents stored in
particular folders or folder trees.
T
Templates
Let you simplify tasks, standardize processes, and improve data security.
Define document structures and initial values for documents, and control who
can view and edit document sections and individual elements within documents.
W
WECO rules
Let you detect out-of-control or non-random conditions on
control charts, based on deviations from the mean. They are also capable of
detecting patterns or trends. For example, you can apply Nelson rule 3 to detect
when six (or more) points in a row are continually increasing (or decreasing).
GAMP
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21 CFR Part 11
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Regulatory compliance aspects
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International Council for Harmonisation (ICH)
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Potency assays
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Content assays
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Impurity assays
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