我们服务的行业:生命科学领域的自动化合规

Validator 为制药、生物技术、医疗器械、营养保健品和 FDA/GxP 监管组织提供随时可进行审计的合规性和数字验证,以满足每个行业的需求。

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专为应对复杂的监管挑战而打造。深受生命科学领域领导者的青睐。

Validator 帮助各种规模的受监管组织实现随时可进行审计的合规性,简化验证流程,并自信地应对变化——即使法规、产品和压力不断演变。我们的自动化平台可灵活适应您所在行业的具体要求,并支持每个验证团队追求质量、效率和可衡量的业务改进。

为什么各行业选择验证器

与其他平台不同,Validator 由其设计团队直接构建、实施和支持。这意味着您始终与专家合作——无需合作伙伴交接,无需担心支持方面的意外情况,也无需担心那些“只卖不做”的供应商。Validator 不仅仅是文档数字化,它实现了真正的端到端流程自动化。

Validator 的独特之处:

 直接部署:Validator 是唯一一个由其创建者自主研发和部署的平台。没有合作伙伴,没有繁琐的流程,而且我们的支持团队对您所在行业的挑战有着切身的了解。

 真正的自动化,而非仅仅是数字化:竞争对手只是将纸质流程转移到屏幕上。Validator 则实现了协议、审批、风险评估、可追溯性和变更控制的全面自动化,从而减少您的人工操作和审计压力。

 100% 客户参考案例:每个验证器实施案例都是成功的,每个客户都愿意分享他们的成果和经验。

 监管一致性:Validator 专为符合 FDA、EMA 和 GxP 标准而构建,内置 CSA 优先工作流程,可快速响应不断变化的全球指南。

 透明定价:SaaS 或企业许可,每个客户均可享受所有功能——无最低消费、无额外收费、无隐藏费用。

 无缝集成:Validator 可以轻松连接到您的 LIMS、MES、ERP 和核心业务系统,从而使您的数据和合规性工作始终保持一致。

 无与伦比的问责制:使用 Validator,始终只有一个团队负责——那就是构建它的团队。

我们服务的行业

Validator深受生命科学领域各行业领导者的信赖。我们针对特定行业提供的解决方案可确保——无论您身处哪个领域——合规性都不会阻碍您的发展:

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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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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)

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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。

用户评价

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