Biological Assay

Quantitative Response / Dichotomous Assay
  • Analysis according to European Pharmacopoeia, Ch. 5.3 and US Pharmacopeia <1032>, <1033>, <1034>
  • Response Adjustment
  • Response Transformations
  • (linear, log, square, square root)
  • Outlier Detection (4 models)
  • Regression models
    • 3-, 4-, and 5-Parameter Fit
    • Linear regression
    • Probit-/Logit
    • Multiplex-Analysis
  • Sophisticated Test System
    • Assay and Sample Suitability
    • Large variety of tests (F-Tests, Equivalence Tests, additional tests)
    • Block Effects
    • Conditional Tests
  • Potency calculation with back-fit
  • Configuration Optimization
Combination Of Assay Results
  • Combination according to European Pharmacopoeia, US Pharmacopeia <111> and <1034>
  • Test System
  • Automatic aggregation from independent assays (optional)
Equivalence Margin Development
  • Automatic aggregation of  data from historic assays (optional)
  • Candidate calculation for up to 30 different equivalence margins.

Control Charts

  • Automatic aggregation of data from your assays (optional).
  • Any number of control limits

Basic Bioassay Protocol

  • Easy workflow to calculate a reportable value for the potency from independent assays.

Measurement Documentation

  • Three different document types for the documentation of your measurement process: Equipment, Operator, Substance

PLATFORM

  • Extensible Platform
    • Document Packages
    • Report Templates
    • Import/Export/Acquisition Modules
  • Coexistence with PLA 1.2, 2.0 and 2.1
  • Microsoft Windows (tm)  7, 8, 10, 2008, 2012, 2016 supported.
  • Supports authentification via LDAP
Data Organization
  • Databases supported:
    • Microsoft SQL Server (tm)
    • File-based database
  • Security
    • Role-based security model
    • Access authorization
  • Audit Trail
    • Logs every document event
    • Logs every system event
  • Electronic Signatures
    • protect documents from modification
    • 21 CFR Part 11
  • Digital Signature
    • protect data integrity
Document Handling
  • 3 Data Editor Perspectives
    • by observation (by row)
    • by sequence (dilution sequence)
    • by position (e.g. plates)
  • Report Engine
    • validated reports
    • extensible
GAMP Support
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ) (Requires Validation Package)

PLA Components

  • PLA 3.0 Base System, including
    • Biological Assays
    • Measurement Documentation
    • General Document Types
  • PLA 3.0 Data Acquisition Modules
  • PLA 3.0 Document Import Modules
  • PLA 3.0 Document Export Modules
  • PLA 3.0 Validation Package
  • Customized Report Templates
  • Individual Solutions

PLA Support Contract

  • 1 year of PLA Support Contract (maintenance contract) included with every purchase
  • Priority support with a target response time of one business day
  • Access to 2nd level support (this includes scientific support)
  • Upgrade and downgrade permission for all covered PLA products during the maintenance time frame
  • Notification service for relevant changes in the guidances
  • Discounted training rates
  • PLA Support Contract can be extended year-by-year or on a long-term agreement.