点击下方“显示更多”图标，以阅读有关法规支持的最常见问题（FAQ）的答案。
In January 2023, the life sciences business of Pall separated from Pall Corporation. Pall’s biotech portfolio is now a product family in Cytiva’s bioprocess business. The Pall medical portfolio will remain a market brand and part of Cytiva. Pall Corporation continues to operate as a Danaher operating company serving customers across a wide range of industrial applications.
监管支持文件包含 Cytiva 销售的一种或多种相关 BioProcess 层析填料产品的专有和非专有信息。该文件包含性能、稳定性、可提取化合物和分析方法的相关信息。它是工艺开发和验证的重要起点，据此编制标准操作程序 (SOP) 及进行质量控制，并可作为向监管机构提交临床和市场准入申请的支持材料。
法规支持文件会不断更新新的信息。当您订阅的法规支持文件更新时，您会收到一封电子邮件通知，告知您有新信息可用。
验证指南（简称 VG）包含产品特性、材料和要求规范、生产工艺、鉴定测试或可提取化合物等信息。Xcellerex 生物反应器、WAVE Cellbag 生物反应器、ReadyToProcess 产品和工艺规模过滤器等一次性产品均有验证指南。验证指南会不断更新新信息。当您订阅的验证指南更新时，您将收到一封电子邮件通知，告知您有新信息可用。
我们软件的验证支持文件包含法规支持文件，这些文件是验证、编制标准操作程序 (SOP) 的重要起点，同时可作为使用我们软件的相关生产工艺的监管申请的支持资料。当您订阅的 VSF 更新时，您会收到一封电子邮件通知。
变更控制通知是对于指定 Cytiva 产品的网络通知系统，您可以通过订阅变更控制通知获得感兴趣的产品信息。当您订阅的某个产品发布通知时，您将收到一封电子邮件。根据我们的标准，变更控制通知包含与产品生产相关的变更信息。
点击 此处阅读更多有关产品和我们标准的信息。
法规支持文件订阅用户可以收到法规支持文件内容变更的通知。按照我们的标准，变更控制通知订阅用户可以收到产品制造有关的变更通知。
点击 此处阅读我们标准的更多信息。
为避免把电子邮件通知当成垃圾邮件（未被选择接收的邮件），系统设计为需要收件人主动选择接收电子邮件通知。
Looking for information on agreements for Accelerator Regulatory Dossier for Allegro™ products? Scroll down, please.
For all products except Allegro™ products:
由于法规支持文件内容的性质，需要签署保密协议的。当您首次请求订阅法规支持文件时，系统会提示您在线接受我们的保密协议。
只订阅变更控制通知的用户不需要签署保密协议。请注意，您只能订阅适用于您所购产品的变更控制通知，如果您滥用该网站来访问您购买的产品以外的其他产品的信息，您对该网站的访问权限可能会被暂停。
保密协议针对每位最终用户。订阅法规支持文件的每位用户都必须代表其所在公司签署保密协议。
该协议有效期为一年。一年后，您将收到一封通知续签协议的电子邮件。登录 Cytiva网站时，系统还会提示您在线续签协议。
当您的协议到期时，您仍会收到订阅监管支持文件的通知。但是，在您在线续签协议之前，您将无法访问这些文件。
For Accelerator Regulatory Dossier for Allegro™ products:
Due to the nature of the content of regulatory support documentation, a confidentiality agreement is required. When you request access to the confidential document in the regulatory dossier, you will be prompted to accept the confidentiality agreement (NDA) via DocuSign. Please refer to the guidance document on How to submit an NDA request in the regulatory dossier.
Users who only subscribe to gated information do not need to sign a confidentiality agreement. Please refer to the guidance document on How to register an account and How to locate the document with regulatory dossier.
The confidentiality agreement is personal to each individual end-user. Each user who would like to review/download confidential regulatory documentation in the regulatory dossier must sign the confidentiality agreement on behalf of their company of employment. Please contact your sales representative/account manager if you have any enquiries regarding the NDA.
The agreement is valid for five years. After five years, if you wish to renew your agreement, please contact your sales representative/account manager.
For third-party documentation, you will need to submit a quotation request to the Global Sales Service Team. Please refer to the guidance document on How to submit a subscription in the regulatory dossier. Once you have subscribed to the dossier, you will be able to see all the regulatory documentation in the system.
Please contact Jacqueline Wong ([email protected]) or Nonny Jarvis ([email protected]) for customer access rights.
Please contact the regulatory documentation team ([email protected]) for documentation enquiries.
保密协议规定了保密信息的使用。请咨询您的法律顾问。
For Accelerator Regulatory Dossier documentation, you can also consult your ACMS admin adviser [email protected].
contact [email protected] 请发送电子邮件至 [email protected]告诉我们谁将替换谁。 新的联系人必须在 法规支持文件/验证支持文件/验证指南或变更控制订阅可以转移之前在线注册。 请注意，可以注册通用的公司电子邮件地址。
请创建一个新帐户。然后将新联系信息发送至 [email protected]，我们将转移您的订阅。
请注意，可以使用公司统一的电子邮件地址进行注册。contact [email protected]
在登录页面上点击 忘记密码？。
法规支持文件的优点在于可以向用户提供第一手信息。而供应商使用药物主文件提供，是为了保护商业机密，其内容仅向 FDA 审查人员披露。法规支持文件可在全球范围内使用，而除活性成分以外的产品的药物主文件（如层析填料）仅适用于美国。
药物主文件包含生产信息，而法规支持文件提供原材料清单，但不说明生产工艺。药物主文件和法规支持文件均无需获得任何当局的批准。其内容仅在进行特定产品申请时供有关部门审查使用。
contact [email protected].请联系 [email protected]
For ACMS/Accelerator Regulatory Dossier support, contact [email protected]
请在以下页面查找您当地的联系人： www.cytiva.com/contact
To open Accelerator Regulatory Dossier PDF files in any internet browser instead of downloading them:
Click the ‘VIEW’ button.
For all other PDF Files
要在 Firefox 中打开 PDF 文件而不是下载它：
- 打开右上角的菜单，然后导航至“选项”。
- 在“常规”选项卡中滚动至“文件和应用程序”部分。
- 在应用程序中搜索 PDF 内容类型，然后选择“在 Firefox 中打开”。
要在 Chrome 中打开 PDF 文件而不是下载它：
- 确保已安装并启用 “Adobe Acrobat” 或 “PDF Viewer” Chrome 扩展程序。
- 通过路径 chrome://settings/content/pdfDocuments 转至 “PDF文档”设置页面。
- 选择“下载PDF文件而不是在Chrome中自动打开”，然后将其切换至“关闭”。
Acrobat® is a registered trademark or trademark of Adobe in the United States and/or other countries. Google Chrome is a trademark of Google Inc. Firefox is a trademark of Mozilla Foundation. Pall is a trademark of Pall Corporation. Any other third-party trademarks are the property of their respective owners.
Historical documentation will remain accessible via the Accelerator Documentation Center homepage.
Validation Guides, Resources, SME (Subject Matter Expert) Corner, Instructional Documentation, and Accelerator Regulatory Dossier will continue to link directly to the original web locations. If you’re using the Accelerator Regulatory Dossier, you must register for an account here.
Regulatory Compliance Statements redirect to the Cytiva Regulatory Statements page.
Quality Documentation redirects to the Cytiva Quality Management page.
Product Batch Certificates redirect to the Cytiva Regulatory Support page.
To contact someone regarding product queries, please create or log in to your Cytiva customer account.
For further information regarding historical documentation, please contact us.
The Accelerator Regulatory Dossier application is the central point of access for product-specific regulatory and compliance documents for all individual components used to manufacture Allegro™ single-use systems. It provides comprehensive and up-to-date documentation, including product specifications, manufacturing information, validation documents, and compliance statements to support your risk assessment, regulatory submissions, and audits.
It also provides drawings via the drawing’s viewer.