PLA - 生物统计分析软件

PLA 是一款生物统计分析软件，被全球监管行业（尤其是制药、生物技术、新药研发及其他生物科学领域）前100强企业广泛采用。该软件涵盖许多功能，提供针对免疫分析、ELISA等场景的丰富生物统计工具，严格遵循各国药典、行业指南及实践要求，确保分析方法合规可靠。初代PLA发布于三十年前。多年来，由科学家、统计学家、数学家、自然科学家及软件专家组成的团队持续创新，使PLA如今已服务全球80多国超过1,000家机构。

 

PLA 为合规保驾护航

本软件无需联网即可运行，购买后无计算费、隐性许可费或其他附加成本，支持长期使用。单一许可证可创建多用户账号，并灵活配置权限管理。用户同时享有行业统计与科学支持服务，可直接与开发该软件数学模型的专家团队沟通。

 

PLA 赋予用户完整控制权，避免云服务商擅自变更导致的合规风险——这在受监管环境中很重要。软件稳定性强，仅需通过自动化安装确认(IQ)、运行确认(OQ)及性能确认(PQ)即可完成初始验证，确保结果一致性。根据ISPE GAMP® 5标准，PLA 3.0属于第3类软件，所有数学运算均受保护不可篡改。内置药典方法库，无需自定义编程。

 

所有在PLA环境中的指令均具备完整追溯性，审计追踪功能记录数据全周期行为，并可立即锁定数据防篡改。支持多种通用格式无缝导入，更提供酶标仪直接数据采集功能，实现数据安荃。

 

全能分析，一应俱全
本软件助您轻松解析数据、获得突破性洞察。集成标准检 测方法与高 级分析工具的组合，助您释放数据价值。内置数据监控功能让您始终掌控全局。

• 生物分析功能
  严格遵循欧洲药典5.3章与美国药典<111>、<1032>、<1033>、<1034>章节，支持定量反应分析（平行线法、平行逻辑法、斜率比法）。提供组合计算全权重方案，支持独立试验数据自动聚合。另含等效界开发、控制图及基础生物分析协议等文档类型。
• 质反应分析
  针对二元（质反应）结果的生物稀释试验，可拟合概率单位(probit)与对数几率(logit)模型，并与标准品进行比对。
• 内毒素浓度检 测
  专为生物梅里埃EndoLISA®与ENDOZYME® II GO试剂盒设计，支持一键生成行业PDF报告，并提供数据导出功能供外部处理。
• 剂量效应关系分析
  提供校准曲线生物统计方法、等效性检验及等效界开发，增强型数据处理与亚组分析功能。支持稀释线性评估、加标回收分析、有效浓度计算及曲线比对，文档报告与仪表板。
• antibiotic效价测定
  依据美国药典<81>与日本药典4.02章，涵盖管碟法与浊度法测定antibiotic效价。完整记录试验设置与材料使用，自动计算效价并生成结果汇总报告。
• 等效界开发
  基于历史数据绘制测试样品个体化图表，建立接受标准。
• 定量反应分析报告值生成
  "基础生物分析协议"提供标准化工作流，从定量反应分析中生成可报告值。
• 数据导入
  通过扩展模块支持酶标仪控制及直接数据导入，兼容Microsoft Excel®及各类文本格式。提供配置模板实现便捷导入。
• 组合计算
  支持全权重方法组合计算、独立试验数据自动聚合及计算分组。
• 合规性文档调整
  在合规前提下修改分析文档，对比不同参数设置效 果。支持按测试样品拆分进行个体化分析。
• 曲线比对
  个性化绘制测试样品曲线，通过文档仪表板或多维报告进行比对，支持多种回归模型。
• 稀释线性评估
  测定不同稀释水平下的方法精密度。
• 高 级统计过程控制
  支持USP<1010>建议的休哈特I-图等控制图。通过定义控制限与规则识别失控数据，状态显示直观反馈违规影响。可选功能包括：标记过程变更的事件日志、箱线图辅助统计、子区间图表创建、置信区间及二级数据分层分析。
• 生物分析模拟
  基于现有试验数据或手动定义参数，模拟定量反应分析行为，深化对方法性能的理解。
• 审计追踪功能
  记录文档所有修改历史，审计日志支持检索与导出。
• 验证服务(IQ/OQ/PQ)
  提供全自动安装确认(IQ)与运行确认(OQ)，以及基于用户数据的半自动化性能确认(PQ)。

 

 

【英文介绍】

PLA is the biostatistical analysis software which is used by all top 100 companies in regulated industries, particularly in pharmaceuticals, biotechnology, drug discovery, and other life sciences sectors. It includes a wide range of functionalities and provides an extensive array of biostatistical tools tailored to immunoassays, ELISA, and more. Of course, PLA provides you exactly with the methods according to the various pharmacopoeias，other guidelines, industry standards and best practices.

 

Utilized versatility with the original

The first version of PLA was released three decades ago. Since then, our experienced team of scientists, statisticians, mathematicians, natural scientists and software developers have been constantly developing and continuously improving PLA. It now has a large user base that includes more than 1,000 organizations in 80 different countries.

 

Be on the safe side using PLA

PLA does not require internet access. After purchase, there are no calculation fees, unexpected licensing costs or any other hidden charges. The software is yours and enables a perpetual usage. Furthermore, you can set up multiple user accounts within your license. Integrate user accounts and manage permissions conveniently with PLA. When you buy the software, you also get access to our statistical and scientific support. Talk to our experts who develop this software and implement its mathematics.

 

Furthermore, you have complete control, eliminating unexpected changes by a cloud operator, which can be fatal in a regulated environment. PLA 3.0 offers stability, requiring only an initial validation with automated IQ, OQ and PQ, ensuring consistent results. PLA 3.0 falls under ISPE GAMP® 5 category 3 as all mathematical operations are safe from modifications. With built-in compendial methods, no custom programming is required.

 

Experience the future of importing data and keep your data secure

Your data remains fully traceable through all actions performed in the PLA environment. When data becomes part of PLA 3.0, everything done with them is stored in the audit trail, and you can prevent any changes to your data right away. Best of all, you can effortlessly import data from a variety of common formats, and our platform even empowers you with direct data import from plate readers, for the highest level of data security. 

 

All you need is in here

This software opens the door and helps you to easily analyze your data and gain insights like never before. Its comprehensive suite of standard assays plus advanced analysis tools are your key to unlocking the full potential of your data. Stay in control and on top of your data with our integrated data monitoring tools.

 

• Analyze Biological Assays

Analyze all types of biological assays according to European Pharmacopoeia, Chapter 5.3 and US Pharmacopeia <111>, <1032>, <1033>, <1034>: Quantitative response assays (parallel-line, parallel-logistic, slope-ratio). PLA also supports all different weighting methods for combination calculations and the automatic data aggregation of independent assay data. Additional document types are available for equivalence margin development, control charts and a Basic bioassay protocol.

 

• Analyze quantal response assays

Analyze biological dilution assays based on a binary (quantal) outcome. Fit probit and logit models to the probability distributions of your sample data and compare them to the reference standard.

 

• Analyze the endotoxin concentration in a substance

Analyze the endotoxin detection assays of the bioMérieux assay kits EndoLISA® and ENDOZYME® II GO. Simplify your reporting process by effortlessly creating professional PDF reports while taking advantage of our data export capabilities for external data processing.

 

• Analyze the dose-response relationship

PLA provides biostatistical methods, equivalence testing and equivalence margin development for calibration curves, enhanced data processing, and subgroup analysis. The methods support linearity-of-dilution assessment, spike-and-recovery analysis, effective-concentration calculation, and curve comparisons. Document reports and dashboards add to its value and usability.

 

• Data analysis

PLA supports a wide variety of methods for biostatistical analysis.

 

• Determine the potency of antibiotics

PLA covers potency estimation of cylinder-plate assays and turbidimetric assays as described in the U.S. Pharmacopeia <81> and Japanese Pharmacopoeia Chapter 4.02 to determine the potency of antibiotics. Document the assay setup and the used materials, calculate the potency, and create a report summarizing your assay and it's results.

 

• Develop Equivalence margins

Individually plot test samples and develop acceptance criteria based on historic data.

 

• Generate reportable values from quantitative response assays

The PLA  'Basic bioassay protocol' provides a general workflow to produce reportable values from Quantitative response assays.

 

• Import your data

PLA supports through its extensibility (add-ons) the plate reader control and its direct import of data, as well as the import of Microsoft Excel® formats and all common text formats. Of course, PLA 3.0 offers you configuration profiles to conveniently import your data.

 

• Perform combination calculations

PLA supports you with all weighting methods for combination calculations, automatic data aggregation of independent assay data and the grouping of combination calculations

 

• Perform compliance-safe adjustments on assay documents

Perform compliance-safe adjustments on assay documents and compare the effects of different analytical settings. You can also split assays by their test samples for an individual analysis. 

 

• Perform a curve comparisons

Individually plot test samples and use the document dashboard or one of the document reports to compare the resulting curves. PLA 3.0 supports various analytical (regression) models.

 

• Perform a Linearity-of-dilution assessment

Determine the precision of your method at different levels of dilution.

 

• Perform a sophisticated statistical process control

PLA allows sophisticated statistical process control (for example, by plotting Shewhart I-Charts as recommended in the USP <1010>). Out-of-control data can be detected by defining control limits and control rules. A status display provides valuable feedback about the impact of a rule violation. Optional features include events to mark changes in the process, sidecharts to contain basic statistics in a box plot, the creation of subcharts for a specific range, and confidence intervals. Moreover, a secondary column can be used to factorize the data series.

 

• Simulate Biological Assays

Simulation of quantitative response assays based on existing assay data and manual definitions of assay characteristics. Improve your insight into the behavior of your methods.

 

• Use the traceability and audit trail

PLA records every change anyone makes to a document in the audit trail of the software. The audit trail can be searched and exported.

 

• Use the validation (IQ, OQ, PQ)

PLA runs a fully automated Installation Qualification (IQ) and Operational Qualification (OQ), and a semi-automated (with your own data) Performance Qualification (PQ).