通过自动验证,每天都能做好审计准备

Validator 可与您的系统无缝集成,实现验证自动化。只需一个集成工具,即可简化合规流程、生成动态文档并做好审计准备。

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效率提升40%

100% 实施成功率

审计准备时间:0 小时

最快3个月即可入住

您准备好迎接下一次审计了吗?

如果您的当前验证系统让您的团队疲于奔命,疲于奔命地追查签名,那么您就需要一种更智能的合规管理方式——一种审计不会占用您的时间或增加您的压力的方式。

生命科学领域的合规挑战

大多数合规工具只是将文档数字化,而没有实现真正重要部分的自动化。验证团队仍然需要使用手动流程,这不仅会引入风险、导致重复工作,还会在审计时造成压力。

让合规成为一种自动化的习惯

A group of people are standing next to each other in circles.

作为验证专业人员,我们将我们在生命科学领域工作中遇到的困难转化为一个平台,该平台受到了制药和生物技术领域一些最受尊敬的公司的信赖。

验证器与您的系统连接,自动执行验证过程的每个阶段,并动态管理文档,使合规性变得轻松无压力。

验证器易于实施,完全可配置,并始终得到我们专家团队的支持——因此您可以充满信心、掌控全局,并做好接受检查的准备。

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300

客户使用 Validator 来管理他们的生命科学公司。

20K

整个行业的用户每天都依赖 Validator。

100%

满意度——问问任何一位客户

25岁以上

在验证解决方案行业拥有多年经验

您可以使用 Validator 实现哪些自动化操作

所有模块均可完全配置,并可直接与您的 LIMS、MES、ERP 和其他业务系统集成——无需自定义开发。

计算机系统验证 (CSV)

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通过实时更新管理审批和执行流程。自动生成方案、风险评估和可追溯性矩阵。所有流程均符合 Part 11 和 GxP 标准。

工艺验证(PV)

A female scientist is working on a computer in a laboratory.

绘制、跟踪并自动化流程验证的所有三个阶段(设计、确认、验证)。通过集成报告管理批次记录和趋势数据。

设备鉴定 (EQ)

A man is using a tablet computer in front of a window.

IQ、OQ、PQ 监督、校准和变更控制集中在一个地方,再也不用到处翻找文件了。

清洁验证

A female scientist is working on a computer in a laboratory.

规范和自动化清洁程序、日程安排和文档记录,以便随时应对任何检查。

积极主动、全面整合、面向未来的合规性

并非所有平台都一样。Validator 的设计和实施都基于丰富的经验——它由曾在生命科学团队工作、主导审计并解决过实际监管问题的人员打造和实施。

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持续合规


实时仪表盘创建动态审计跟踪,因此您的团队可以根据最新数据开展工作,并确保您的合规性随时准备接受检查。

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与您的系统集成


每个连接都可以完全配置到您的 LIMS、ERP、MES、HR、财务和风险系统,无需自定义代码,因此您可以访问和个性化设置,而无需联系 IT 部门。

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快速投资回报,高效可靠


效率提升超过 40%,实施成功率 100%。验证器配置完成并流畅运行,3 个月内即可实现快速投资回报。

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始终保持最新状态


随着监管标准的演变,验证器也在不断演变,以确保您的验证系统符合 CSA 和全球统一的实践,从而实现国际合规性。

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值得信赖的传统,着眼未来

Validator深受初创公司和财富500强企业的信赖,并依托Compliance Associates的良好声誉、丰富资源和实践经验。如果您想了解Validator背后的团队,或进一步了解我们的咨询和数字化转型服务,请访问Compliance Associates网站。

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工作原理

number 1

业务流程图绘制研讨会

我们首先会举办一次研讨会,帮助您梳理流程并找出效率低下的环节。

number 2

个性化和配置

我们的专家团队会为您配置 Validator,使其与您的所有系统保持一致,并使其快速运行——无需任何自定义代码。

number 3

专家主导的培训和支持

我们会对您的团队进行实操培训,并提供持续支持,确保每个人都能自信地使用 Validator。

number 4

时刻准备迎接每一次审计

您的文档始终保持最新状态。合规变得轻松,审计变得简单明了,结果也易于衡量。

保证您前 90 天的体验将得到指导、取得成功并可衡量。

了解 Validator 如何简化您的验证流程,并帮助您实现 100% 合规性。

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验证者深受领导团队的信任

a scientist looking on a microscope

Pharmaceuticals

Streamline compliance and validation across pharmaceutical manufacturing, labs, and R&D sites. Validator automates documentation, ensures data integrity, and helps your teams focus on innovation while keeping you audit-ready—so you can bring products to market faster and with full regulatory confidence.
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Biotechnology

Biotechnology companies rely on Validator to simplify complex validation requirements, manage batch records, and maintain stringent compliance as they scale. From early-stage ventures to established leaders, Validator accelerates growth and strengthens quality systems with automation tailored to biotech’s dynamic needs.
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Medical Devices

For medical device manufacturers, quality and compliance are non-negotiable. Validator standardizes protocols, automates validation documentation, and improves traceability—helping you navigate FDA, ISO, and global regulations while making it easier to innovate, launch, and scale.
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Life Sciences

Validator empowers life sciences organizations to automate validation and compliance across research, development, and manufacturing—accelerating innovation, improving efficiency, and ensuring data integrity for confident, global compliance.
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FDA/GxP Regulated Organizations

Validator is built for teams operating in highly regulated environments—pharmaceuticals, biotech, medical devices, and beyond. Automate end-to-end validation, standardize best practices, and keep all your data audit-ready. With Validator, compliance becomes a strategic advantage, not just a regulatory hurdle.
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过往业绩卓著

Validator 不仅仅是为生命科学行业打造的——它是由生命科学行业人士开发的。我们 Compliance Associates 的专家验证顾问团队拥有数十年的实践经验,每一项功能都基于监管合规的实际情况。

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300 客户

已由 300 多家生命科学公司实施——从快速发展的生物技术公司到全球制药领导者。

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25年以上领导经验

Compliance Associates 在开发、实施和改进数字验证解决方案方面一直处于行业领先地位。

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2万 用户

超过 20,000 名用户依靠 Validator 来管理文档、准备审核和跟踪资格认证任务。

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100% 实施成功率

所有验证器部署都100%成功。您可以询问任何一位客户。我们的客户都实现了他们的目标,并乐于分享他们的经验。

每一位客户都是您的参考案例。

以下是我们部分客户及其评价。

Validator takes a systematic approach to the process of validation. With no ambiguities in the process audits are easy to defend and information is easily accessible.
Han Duong
Director of Information Systems
We had the added benefit of working alongside the creators of the software. The product was so responsive to our needs that it was like having a custom tool built to fit the matrix of our business.
Alexia Pico
Supervisor, Development Translational Medicine
Validator helps someone without a complete knowledge of computer system validation get up to speed and become a contributing team member faster, because they have all the tools and templates available, and know where to find everything they need.
Steris

Instead of physical documents being moved throughout our organization globally, being printed and rescanned six or more times, compliance document reviews and approvals will now take only minutes. Compliance and integrity is improved, because we are able to keep documents and information uncorrupted by human error.

Sachin Bhandari
Global Head Compliance at SunPharma
We understood that implementing better technology would help us perform validation with greater ease, speed and efficiency.
Esra Guven
Principal Consultant for the Systems Qualification & Compliance Group
Validator is helping us complete validation projects better than before.
Alok Varshney
Manager of the Systems Qualification & Compliance Group