医疗器械文档控制

Medical device document management and control is the underpinning of your company’s Quality Management System. The documents and records that you maintain and how you control them will highlight to the world that your products are safe and efficacious to use.

医疗设备文件管理和控制是您公司质量管理体系的基础。您维护和控制的文件和记录将向世界展示您的产品使用安全有效。

Under regulatory standards like ISO 13485 and the FDA 21 CFR Part 820, you are obliged to maintain and control certain documents. In addition, if your company uses an electronic document control solution, FDA 21 CFR Part 11 will highlight the ways and means of handling electronic records and signatures.

根据 ISO 13485 和 FDA 21 CFR 第 820 部分等监管标准，您有义务维护和控制某些文件。此外，如果您的公司使用电子文件控制解决方案，FDA 21 CFR 第 11 部分将强调处理电子记录和签名的方式和方法。

As a medical device QMS software provider, having helped medical device companies of all sizes across the globe switch effortlessly from traditional paper-based QMS systems to digital software solutions, we know a thing or two about document control.

作为一家医疗设备 QMS 软件提供商，我们帮助全球各大小医疗设备公司轻松从传统的纸质 QMS 系统转换为数字化软件解决方案，对文件控制有一些了解。

In this article, we will delve into the main requirements for a medical device document control system, the problems that companies face with traditional systems, how you can streamline the entire document control process, as well as the benefits you accrue when you invest in a digital document control solution.

在本文中，我们将深入探讨医疗设备文件控制系统的主要要求，公司在传统系统中面临的问题，以及您在投资数字化文件控制解决方案时所获得的好处。

What is Medical Device Document Control? 医疗器械文件控制是什么？

Medical device document control can be defined as the processes and procedures that organizations operating in the medical device industry will systematically apply to guarantee that the documents pertaining to the lifecycle of a medical device product will be created, re-evaluated, circulated, and disposed of in a provable and organized manner.

医疗器械文件控制可以被定义为医疗器械行业中的组织将系统地应用于保证与医疗器械产品生命周期相关的文件将以可证明和有组织的方式创建、重新评估、传播和处置的过程和程序。

Such document control is at the crux of your medical device quality management system. It is also mandated under international regulatory standards, including FDA 21 CFR Part 820, ISO 13485:2016, EU MDR, and FDA 21 CFR Part 11. More on this in a bit.

这种文件控制是您的医疗器械质量管理体系的核心。它也是国际监管标准的强制要求，包括 FDA 21 CFR 第 820 部分、ISO 13485:2016、欧盟 MDR 和 FDA 21 CFR 第 11 部分。稍后详细介绍。

Let us take the example of the AI-enhanced remote ultrasound system. It is but natural that you will put your best foot forward! Your company will ensure that every minute detail is looked into, as there will be a lot of scrutiny from space agencies, regulatory agencies, the public, and your competitors. One of the best ways to ensure that your product is accepted is with efficient documentation and document control.

让我们以 AI 增强的远程超声波系统为例。你自然会尽力而为！你的公司将确保每一个细节都被仔细研究，因为太空机构、监管机构、公众和竞争对手都会进行严格审查。确保你的产品被接受的最好方法之一是高效的文档和文档控制。

Difference Between Document Control and Document Management 文档控制和文档管理之间的主要区别

The main difference between document control and document management is that document management indicates the systems and procedures that your company will put in place to maintain and manage documentation pertaining to the lifecycle of a medical device product.

文档控制和文档管理之间的主要区别是，文档管理指的是您的公司将采取的系统和程序，以维护和管理与医疗设备产品的生命周期相关的文档。

This means the “how’s and why’s” of storage, tracking, updating, and sharing of such documents.

这意味着存储、跟踪、更新和共享此类文档的“如何和为什么”。

Document control is the practices in place to ensure the creation, review, distribution, and disposal of documents of the lifecycle of a product methodically.

文档控制是确保产品生命周期的文档的创建、审查、分发和处置的实践方法。

For example, during the conceptualization and manufacture of the enhanced remote ultrasound system, you will be generating tonnes of documents. With a document management system, you will store, track, update, and share these documents with relevant personnel and stakeholders. How you create, distribute, and dispose of these documents will fall under the purview of document control.

例如，在增强型远程超声系统的概念化和制造过程中，您将生成大量文件。通过文档管理系统，您可以存储、跟踪、更新和与相关人员和利益相关者共享这些文件。您如何创建、分发和处理这些文件将属于文件控制的范畴。

You can streamline your document control processes with our medical device document control software. It helps you manage and control documents, control changes, and approve documents electronically. Furthermore, the SimplerQMS document control solution is part of the quality management suite, which is a complete end-to-end quality management solution for medical device companies.

您可以使用我们的医疗设备文档控制软件简化您的文件控制流程。它可以帮助您管理和控制文件，控制变更，并电子化批准文件。此外，SimplerQMS 文档控制解决方案是质量管理套件的一部分，该套件是医疗设备公司的完整端到端质量管理解决方案。

Medical Device Document Control Requirements 医疗器械文件控制要求

Effective document control is at the crux of all life sciences companies, including medical device manufacturers. Several international guidelines govern it.

有效的文件控制是所有生命科学公司的关键，包括医疗器械制造商。有几个国际指南对其进行管理。

They are as follows:

它们如下：

FDA 21 CFR Part 820.40 FDA 21 CFR 第 820.40 条
ISO 13485: 2016 ISO 13485: 2016
EU MDR 欧盟 MDR
FDA 21 CFR Part 11 FDA 21 CFR 第 11 条

FDA 21 CFR Part 820.40

FDA 21 CFR Part 820 is the standard from the US Government’s Food and Drugs Administration (FDA) that applies to current good manufacturing practice requirements for all finished medical devices that are intended for human use in the United States.

FDA 21 CFR 第 820 部分是美国政府食品和药物管理局（FDA）的标准，适用于在美国用于人类的所有成品医疗器械的当前良好制造规范要求。

When we consider document control, we need to refer specifically to section 820.40 of the FDA 21 CFR Part 820, which states the following.

当我们考虑文件控制时，我们需要特别参考 FDA 21 CFR 第 820 部分的 820.40 节，该节规定如下。

“Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:

“每个制造商都应建立和维护程序，以控制本部分所要求的所有文件。这些程序应包括以下内容：

(a) Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve before issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.

(a) 文件批准和分发。每个制造商都应指定一个或多个人员，对满足本部分要求的所有文件进行充分审查和批准后再发布。批准文件的个人（们）的日期和签名应有记录。满足本部分要求的文件应在指定、使用或其他必要的所有地点都可获得，所有过时的文件应及时从所有使用点移除或以其他方式防止意外使用。

(b) Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.”

(b) 文档更改。文档的更改应由执行原始审查和批准的同一职能或组织的个人进行审查和批准，除非另有明确指定。批准的更改应及时通知相关人员。每个制造商应保留文档更改的记录。更改记录应包括更改的描述，受影响文档的标识，批准个人的签名，批准日期以及更改生效日期。

Succinctly, section 820.40 states that medical device companies selling their products in the US market should have protocols and procedures for the control of all pertinent documents as highlighted in the FDA’s Quality Systems Regulations (QSR).

简而言之，第 820.40 节规定，在美国市场销售其产品的医疗器械公司应具有协议和程序，以控制 FDA 的质量体系规定（QSR）中强调的所有相关文档。

ISO 13485:2016 Section 4.2.4

The International Organization for Standardization (ISO) guidelines provide medical device companies with the standards for their Quality Management Systems.

国际标准化组织（ISO）的指南为医疗器械公司提供了其质量管理体系的标准。

Section 4.2.4 (Control of Documentation) of ISO 13485:2016 specifically states that:

ISO 13485:2016 的 4.2.4 节（文件控制）明确规定：

“Documents required by the quality management system shall be controlled.”

“质量管理体系所需的文件应受控制。”

In this section, the magnitude of document control is emphasized for the entirety of a medical device’s lifecycle.

在本节中，强调了对整个医疗器械生命周期的文件控制的重要性。

ISO 13485:2016 Section 4.1.6

Furthermore, section 4.1.6 of ISO 13485:2016 highlights a company’s requirements for computer system validation in the following way.

此外，ISO 13485:2016 的 4.1.6 节强调了公司对计算机系统验证的要求，具体如下。

“The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.”

“组织应为质量管理系统中使用的计算机软件的应用编制验证程序的文件。在初始使用之前，应对此类软件应用进行验证，并在软件或其应用发生变化后适当地进行验证。”

This becomes important when we consider the use of an electronic document management system or electronic QMS.

当我们考虑使用电子文件管理系统或电子质量管理系统时，这变得很重要。

EU MDR

The Medical Device Regulation of the European Union (EU MDR) which came into full effect on the 26th of May, 2021 contains many relevant points when it comes to document control.

欧洲联盟（EU MDR）的医疗器械法规于 2021 年 5 月 26 日全面生效，涉及到文件控制的许多相关要点。

The emphasis is on the complete lifecycle of a medical device, including:

重点是医疗器械的完整生命周期，包括：

Periodic safety update reports (PSUR) 定期安全更新报告（PSUR）
Document storage retention 文件存储保留
Post-market surveillance systems 市场后监测系统

Periodic safety update reports (PSURs) are pharmacovigilance documents that your company will submit to the regulatory agency regularly to disclose the worldwide safety experience of a product.

定期安全更新报告（PSUR）是药物监管文件，您的公司将定期向监管机构提交该报告，以披露产品的全球安全经验。

Post-market surveillance reports are for medical devices that are already on the market. Your company will collect and evaluate the experiences gained from such medical devices and determine if you need to take any further action.

市场后监测报告适用于已上市的医疗器械。您的公司将收集和评估从这些医疗器械中获得的经验，并确定是否需要采取进一步的行动。

Recommended Reading

Summary of Key Requirements for Document Control in Medical Device Companies 医疗器械公司文件控制的关键要求摘要

文件控制协议：您的公司需要一个可靠和标准化的政策来管理所有相关文件。

International regulations and standards, including FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR have several commonalities that are listed below:

国际法规和标准，包括 FDA 21 CFR 第 820 部分，ISO 13485:2016 和欧盟 MDR 有以下几个共同点：

Document control protocols: Your company requires a dependable and standardized policy for the management of all relevant documents. 文件的最新版本：公司内流通的文件和适用位置上的文件必须仅以最新的最新版本提供。
An up-to-date version of the document: The documents in circulation and those present at applicable locations in your company must be available only in the latest up-to-date versions. 文档的最新版本：您公司流通中的文档和适用地点上的文档必须仅提供最新的最新版本。
Rules for document control approvals: 文档控制批准规则：
1. All document control approvals in your company must compulsorily include the signatures of the person(s) approving the said document, with the date on which the approval was given. 您公司的所有文档控制批准必须强制包括批准该文档的人员的签名，并注明批准日期。
2. Such approved changes in documents need to be communicated with the relevant personnel in all concerned departments. 这些已批准的文档更改需要与所有相关部门的相关人员进行沟通。
3. Any changes in a document must be reviewed and approved by the person(s) who was initially involved in the original review and approval. 文档的任何更改必须由最初参与原始审查和批准的人员进行审查和批准。
Evaluation of procedures: The senior management in your company will identify the most appropriate person(s) who will evaluate all protocols concerning pertinent documents. 程序评估：您公司的高级管理人员将确定最合适的人员来评估所有与相关文档有关的协议。

FDA 21 CFR Part 11

The US FDA describes 21 CFR Part 11 in the following way:

美国 FDA 以以下方式描述了 21 CFR 第 11 部分：

“The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.”

“本部分的规定阐明了机构认为电子记录、电子签名和手写签名执行的电子记录具有可信度、可靠性，并且与纸质记录和纸质上执行的手写签名基本等同的标准。”

FDA 21 Part 11 applies to your company if you are using any type of electronic document management software. Even if you have a paper-based documentation system, but use email for sending and receiving documents, scan documents electronically, and/or have a server for storing electronic versions of documents, you will have to be compliant with this FDA regulation.

如果您使用任何类型的电子文件管理软件，FDA 21 第 11 部分适用于您的公司。即使您有一个基于纸质的文档管理系统，但使用电子邮件发送和接收文件，电子扫描文件，并/或者有一个用于存储电子文件版本的服务器，您也必须符合这个 FDA 规定。

Essential FDA 21 CFR Part 11 Software Requirements

When your medical device company has transitioned into a 21 CFR Part 11 compliant document management system, the following requirements become applicable to you:

当您的医疗设备公司过渡到符合 21 CFR 第 11 部分的文件管理系统时，以下要求适用于您：

System validation: Your company should authenticate the system software regularly. This is needed to ensure that all components of the system are working as projected. 系统验证：您的公司应定期验证系统软件。这是为了确保系统的所有组件都按预期工作。
Operational controls: The system in your company will utilize a phase-gate process for analyzing and controlling all quality procedures. 操作控制：您公司的系统将使用阶段门控过程来分析和控制所有质量程序。
Record generation: The system should effectively and efficiently generate exact copies of records and documents that concern your company’s Quality Management System. In addition to electronic copies it should be able to generate physical printouts, whenever required. 记录生成：系统应有效且高效地生成与贵公司质量管理体系相关的记录和文件的精确副本。除了电子副本外，它还应能够在需要时生成实体打印件。
Audit trails: The audit history file of the system should be able to store all new documents, modified documents, and deleted documents. The audit history file should not be modifiable. These features allow your company to have a secure and trustworthy audit trail of all records and documents generated by the company. 审计追踪：系统的审计历史文件应能够存储所有新文件、修改文件和删除文件。审计历史文件不应可修改。这些功能使贵公司能够拥有安全可靠的审计追踪，记录公司生成的所有记录和文件。
Training: Any person who needs to access the document control solution must first be properly trained. They should have the requisite education and experience to handle assigned duties. 培训：任何需要访问文件控制解决方案的人必须首先接受适当的培训。他们应具备处理所分配职责的必要教育和经验。
Electronic signatures: An important feature of an electronic document control system is the ability to generate electronic signatures of the person(s) reviewing and approving documents. These signatures will also contain the name(s) of the signatory, ownership, date, and time. 电子签名：电子文档控制系统的一个重要特性是能够生成审核和批准文件的电子签名。这些签名还将包含签署人的姓名、所有权、日期和时间。

通过投资于预验证的医疗设备 QMS 解决方案（如 SimplerQMS），您可以简化符合文件控制要求的过程。

Security controls: You will allow only relevant personnel to access the system with the help of unique login usernames and passwords. 安全控制：您将通过独特的登录用户名和密码，只允许相关人员访问系统。

Check out our article on the FDA 21 CFR Part 11 software requirements to learn more about this topic.

查看我们关于 FDA 21 CFR Part 11 软件要求的文章，以了解更多相关内容。

You can simplify compliance with document control requirements by investing in a pre-validated medical device QMS solution, like SimplerQMS.

您可以通过投资于预验证的医疗设备质量管理体系（QMS）解决方案，如 SimplerQMS，简化符合文件控制要求。

SimplerQMS has been purposely built to help medical device companies work more efficiently and meet stringent regulatory requirements such as FDA 21 CFR Part 820, ISO 13485:2016, EU MDR, and FDA 21 CFR Part 11.

SimplerQMS 旨在帮助医疗器械公司更高效地工作，并满足严格的监管要求，如 FDA 21 CFR 第 820 部分，ISO 13485:2016，欧盟 MDR 和 FDA 21 CFR 第 11 部分。

We provide QMS software with built-in document controls for medical device companies, which include features like automatic version, revision control, FDA 21 CFR Part 11 compliant digital signatures, and time-stamped audit trails for all document changes. In addition, a centralized, cloud-hosted repository assures both compliance and audit readiness.

我们为医疗器械公司提供带有内置文档控制功能的 QMS 软件，其中包括自动版本、修订控制、符合 FDA 21 CFR 第 11 部分的数字签名和时间戳审计跟踪所有文档更改。此外，集中式的云托管存储库确保合规性和审计准备性。

The Challenges of Traditional Medical Device Document Control 传统医疗设备文件控制的挑战

When medical device companies use traditional paper-based legacy systems, and/or ad-hoc document control systems, or hybrid document control systems, they will face many challenges. This applies equally well to both small and large organizations.

当医疗设备公司使用传统的基于纸张的遗留系统，和/或临时文件控制系统，或混合文件控制系统时，他们将面临许多挑战。这同样适用于小型和大型组织。

These challenges can be categorized as presented below.

这些挑战可以按照下面的方式进行分类。

Document Version Control Confusion 文件版本控制混乱

With paper-based document control systems, even the best-organized companies can have major issues with document version control.

在基于纸张的文件控制系统中，即使是最有组织的公司也可能在文件版本控制方面遇到重大问题。

How will you ensure that all departments within the organization have only the most current versions of relevant documents?

您将如何确保组织内的所有部门只有相关文件的最新版本？

It becomes cumbersome and a waste of precious resources tracking down document activity and keeping track of specific changes in every document.

追踪文件活动并跟踪每个文件中的具体更改变得繁琐且浪费宝贵的资源。

Imagine this scenario – the manufacturing unit in a medical device company is relying on a document related to third-party selection that is over two years old. They are not aware that this document was superseded by a newer version six months back.

想象一下这种情况——医疗设备公司的制造部门依赖于一份与第三方选择相关的文件，该文件已经超过两年了。他们不知道这个文件在六个月前被更新了一个新版本。

Time Inefficiency 时间效率

A major challenge that companies using paper-based document control systems face is the waste of valuable time.

使用纸质文件控制系统的公司面临的主要挑战是浪费宝贵的时间。

You are likely to put in much effort to: 您很可能会付出很多努力来：
Route documents to relevant departments. 将文件发送给相关部门
Have discussions and make changes. 进行讨论和更改
Get authorized staff to approve and sign these documents. 让授权人员批准和签署这些文件
Hunt for misplaced documents and records. 寻找错放的文件和记录
Etc. 等等。

For example, the FDA/ISO auditors have come to audit a medical device company. They ask for certain documents to be submitted during the audit. These documents need to be retrieved from the specific department. This can take the time that should have been utilized more meaningfully.

例如，FDA/ISO 审计员已经来到一家医疗设备公司进行审计。他们要求在审计期间提交某些文件。这些文件需要从特定部门检索。这可能会花费本应更有意义的时间。

Ineffective Document Collaboration 无效的文件协作

Anyone who continues to use physical paper-based systems will know that it is very difficult to make multiple edits and then circulate the latest version of a document to their designated areas.

任何继续使用纸质系统的人都知道，很难对多个文件进行多次编辑，然后将最新版本传达给指定区域。

It takes a lot of time and effort to ensure that everyone has received the same version. And there is also no guarantee that all relevant personnel will receive the updated document on time.

确保每个人都收到相同版本的文件需要花费大量时间和精力。而且也不能保证所有相关人员能够及时收到更新的文件。

Lack of Security 安全性不足

When documents are manually filed in a retrieval system, the person(s) handling this task may file them under the wrong name or even lose the document.

当文件手动归档到检索系统时，处理此任务的人员可能会将其归档到错误的名称下，甚至丢失文件。

Also, how will the company ensure that sensitive documents are secured?

此外，公司如何确保敏感文件的安全？

Is it not possible for a disgruntled employee or a competitor to break into a physical retrieval system and gain access to proprietary information?

一个不满的员工或竞争对手不可能闯入物理检索系统并获取专有信息吗？

Lack of Accessibility 可访问性不足

Accessibility issues are plenty with paper-based document systems.

基于纸张的文件系统存在许多可访问性问题。

For example, a key senior staff member is on sick leave when their signature is urgently required on a crucial document.

例如，当一份关键文件急需某位高级员工的签名时，该员工正在病假。

How will this document be validated in the absence of this person?

在该人员缺席的情况下，该文件将如何得到验证？

Ineffective Communication 无效的沟通

Inevitably with traditional documentation systems communications is not efficient.

传统的文档系统通信效率不高。

You need to communicate with multiple stakeholders during the entirety of a medical device lifecycle, including but not limited to:

在整个医疗设备生命周期中，您需要与多个利益相关者进行沟通，包括但不限于：

Internal departments 内部部门
Branches of the company in different locations 不同地点的公司分支机构
Third-party vendors 第三方供应商
Regulatory agencies 监管机构
Product end-users 产品最终用户
And others 以及其他人

Inefficient communication can result in delayed supplies, recalls, and even more serious, and warning letters.

低效的沟通可能导致供应延迟、召回甚至更严重的警告信。

Lack of Oversight 缺乏监督

When a company is reliant on paper-based systems, unintentional failures can creep in because of a lack of proper oversight.

当一个公司依赖纸质系统时，由于缺乏适当的监督，意外的失误可能会出现。

Documents may remain unsigned, documents may be stored in multiple locations, and you may be too reliant on multiple people and different tools such as spreadsheets and Google docs.

文件可能未签署，文件可能存储在多个位置，您可能过于依赖多个人和不同的工具，如电子表格和谷歌文档。

All of these can result in inaccuracies creeping in.

所有这些都可能导致不准确性的出现。

Difficulty Maintaining Regulatory Compliance 难以维持合规性

When a company has a paper-based system in place, they are reliant on its personnel to be up-to-date with the latest regulatory standards and guidelines.

当一家公司采用纸质系统时，他们依赖于其人员了解最新的法规标准和指南。

What if this person(s) is still unaware of the recent EU MDR guidelines?

如果这个人（们）仍然不知道最近的欧盟 MDR 指南怎么办？

And the list of such issues goes on…

而这类问题的清单还在继续…

Do you find yourself facing any of these challenges?

您是否面临这些挑战？

Well, rather than trying to work around these inefficiencies, medical device organizations are now turning to software solutions for a better way to manage their documents.

嗯，与其试图绕过这些低效率，医疗设备组织现在转向软件解决方案来更好地管理他们的文件。

The problems with security, document versions, accessibility, editing, and manual processes can all be remedied with the right software solution, like SimplerQMS. At the same time, maintaining compliance with stringent regulatory requirements is made easier.

安全性、文件版本、可访问性、编辑和手动流程的问题都可以通过正确的软件解决方案（如 SimplerQMS）得到解决。同时，更容易满足严格的法规要求。

How to Streamline and Simplify Your Medical Device Document Control System 如何简化和简化您的医疗器械文件控制系统

Documentation and document control are of the utmost essence for a company that deals with products that affect human lives. Having considered what document control is, and the common challenges of traditional paper-based systems, let us check on some of the best practices for streamlining and simplifying medical device document control.

对于一家涉及影响人类生命产品的公司来说，文档和文档控制至关重要。在考虑了文档控制的含义和传统纸质系统的常见挑战之后，让我们来看一些简化医疗器械文件控制的最佳实践。

Employ a Document Controller 雇用一个文件控制员

A document controller, or document control specialist, is a technically proficient person who is in charge of all document control activities in the organization.

文件控制员，或文件控制专员，是一个技术熟练的人，负责组织中的所有文件控制活动。

Depending on the size of the company, you may employ more than one document controller. Since document control needs technical expertise in several areas, it is prudent to have more than one document control specialist, especially in larger companies.

根据公司的规模，您可能会雇用多个文件控制员。由于文件控制需要在多个领域具备技术专长，因此在较大的公司中拥有多个文件控制专员是明智的选择。

Have Procedures and Protocols in Place for Document Control 建立并实施文件控制的程序和协议

The organization should have a Quality manual for all document control procedures.

组织应该为所有文件控制程序拥有一个质量手册。

The Quality Manual will emphasize a standardized and controlled manner to organize documents and data.

质量手册将强调以标准化和受控的方式组织文件和数据。

The key aspects of the Quality Manual include:

质量手册的关键方面包括：

Creating documents 创建文件
Review and approval 审查和批准
Revisions to documents 文件修订
Publishing documents 发布文件
Disposal or archiving of old documents 处理或归档旧文件

Employ Standard Naming Conventions for All Your Documents 为所有文档使用标准命名约定

A standard file naming convention provides your organization with the proper structure for listing all files. This will help describe the contents of each file and their relationship to other files.

标准的文件命名约定为您的组织提供了适当的结构，以列出所有文件。这将有助于描述每个文件的内容以及它们与其他文件的关系。

Good practices for naming files are:

命名文件的良好实践包括：

Consistent names for files 文件名称一致
Short yet descriptive file names (<25 characters) 文件名称简短但具有描述性（<25 个字符）
Avoidance of special characters and spaces in the file name 避免在文件名中使用特殊字符和空格
Inclusion of the version number 包含版本号

An example of a standard file naming convention is given below:

以下是标准文件命名约定的示例：

A numbering system for large files/folders 大文件/文件夹的编号系统
The project Lead’s Initials/last name-first name 项目负责人的首字母/姓-名
The file creator’s initials/last name-first name 文件创建者的首字母/姓-名
Project title or a suitable acronym for common file types (for example- BD= business documentation) 项目标题或常见文件类型的合适缩写（例如- BD=商业文件）
The date on which the file was generated or created (either DD/MM/YY or YY/MM/DD depending on which side of the Atlantic Ocean you are located) 文件生成或创建的日期（根据您所在的大西洋两岸，可以是 DD/MM/YY 或 YY/MM/DD）
The version number of the file 文件的版本号

Your organization can consider following a similar convention. This will go a long way towards streamlining and simplifying your document control procedures.

您的组织可以考虑遵循类似的约定。这将大大简化和简化您的文档控制程序。

Leverage the Use of Reusable Document Forms and Templates 利用可重复使用的文档表格和模板

Your staff should not waste their time redeveloping document forms and templates for every new project. When you have reusable forms and templates that have withstood the test of time, it makes life much easier for everyone.

您的员工不应该浪费时间为每个新项目重新开发文档表格和模板。当您拥有经受时间考验的可重复使用的表格和模板时，这将使每个人的生活变得更加轻松。

Some examples of reusable document forms and templates include:

一些可重复使用的文档表格和模板的例子包括：

Non-conformance Report (NCR) templates 不符合报告（NCR）模板
Corrective Action and Preventive Action (CAPA) form templates 纠正措施和预防措施（CAPA）表格模板
Change Control forms 变更控制表格
Complaints and Calibration forms 投诉和校准表格
Training Attestation forms 培训证明表格

Utilize Cloud Storage 利用云存储

With cloud storage, you will be storing your files on cloud servers.

通过云存储，您将把文件存储在云服务器上。

Even if a server crashes, your precious data is accessible from other locations, thanks to data backup and recovery services.

即使服务器崩溃，由于数据备份和恢复服务，您的宝贵数据也可以从其他位置访问。

For example, in SimplerQMS data backups are executed every 15 minutes, stored in multiple geographical locations, and monitored by professionals 24/7. This ensures that your data is always safe and sound, no matter what happens.

例如，在 SimplerQMS 中，数据备份每 15 分钟执行一次，存储在多个地理位置，并由专业人员 24/7 监控。这确保您的数据始终安全可靠，无论发生什么情况。

Establish a Single Source of Truth 建立一个真实信息的单一来源

The documents that your company generates throughout the lifecycle of a medical device product highlight the authenticity of the processes and protocols. These documents will assure your stakeholders that your products are of high quality, safe, and efficacious for human use.

您的公司在医疗设备产品的整个生命周期中生成的文件突出了流程和协议的真实性。这些文件将向您的利益相关者保证您的产品具有高质量，安全，并且对人类使用有效。

Essentially it means that these documents are a single source of truth. So, document control is imperative for this purpose.

本质上，这意味着这些文件是真实信息的单一来源。因此，为了实现这个目的，文档控制是必不可少的。

By centralizing all documents in a single repository, ensuring that only the latest version of documents is in use, the history of every document is traceable, and streamlining communication and collaboration between departments and stakeholders, you will have a single source of truth.

通过将所有文档集中存储在一个仓库中，确保只使用最新版本的文档，每个文档的历史可追溯，并简化部门和利益相关者之间的沟通和协作，您将拥有一个真理的单一来源。

Make Continuous Improvements 持续改进

When your company is expanding or becoming more established, you will need to make improvements to your document control system. The restructuring of the document control system to suit your current needs can be intimidating.

当您的公司扩张或变得更加稳定时，您需要对文档控制系统进行改进。将文档控制系统重组以适应当前需求可能会让人感到害怕。

But, by splitting each step into smaller manageable phases, the work becomes easier.

但是，通过将每个步骤分解为更小的可管理的阶段，工作变得更容易。

Your organization can start by ensuring that copies of all documents are stored in a secure centralized repository. Make certain that you have proper filing systems for the latest versions vis-à-vis obsolete versions of these documents. Also, schedule reoccurring document review tasks and make it a point to review and update the documents on a regular basis.

您的组织可以从确保所有文档的副本存储在安全的集中存储库中开始。确保您拥有适用于这些文档的最新版本与过时版本的适当归档系统。此外，安排定期的文档审查任务，并定期审查和更新文档。

Integrate With eQMS and Automate the Core QMS Processes 与 eQMS 集成并自动化核心 QMS 流程

The steps mentioned so far can all be implemented manually.

到目前为止提到的步骤都可以手动实施。

But, for document control to work fully and most efficiently, you can consider automating the completed documentation processes and integrating them using an eQMS software solution like SimplerQMS.

但是，为了使文档控制能够完全并且高效地工作，您可以考虑自动化完成的文档处理流程，并使用 SimplerQMS 等 eQMS 软件解决方案进行集成。

By connecting your document control system with an entire QMS, you will be able to automate and streamline core QMS processes. This will enable real-time collaboration between departments and stakeholders, give you full traceability, timely reminders, easier audits and regulatory compliance management, and better management of all your documents, using one central system.

通过将您的文档控制系统与整个 QMS 连接起来，您将能够自动化和简化核心 QMS 流程。这将实现部门和利益相关者之间的实时协作，为您提供完整的可追溯性，及时的提醒，更容易的审计和合规管理，以及使用一个中央系统更好地管理所有文档。

Streamline Document Control at Your Medical Device Organization 简化医疗器械组织的文件控制

Traditional medical device document control using paper-based systems or a mix of paper and electronic files has its inherent challenges. These include the utilization of precious resources including time for such manual processes and the possibility of errors creeping in.

传统的医疗器械文件控制使用基于纸张的系统或纸质和电子文件的混合方式存在固有的挑战。这些挑战包括利用宝贵资源，包括用于手动流程的时间，以及可能出现的错误。

All of these can expose your company to compliance issues with regulatory agencies. This can further compound into product recalls.

所有这些都可能使您的公司面临与监管机构的合规问题。这可能进一步导致产品召回。

SimplerQMS provides you with medical device document control software that is a part of the quality management suite, providing a complete closed-loop quality management solution.

SimplerQMS 为您提供医疗器械文件控制软件，该软件是质量管理套件的一部分，提供完整的闭环质量管理解决方案。

Features like automatic version control, revision control, electronic signature, full audit trails, automated document workflows, and others make it easier for you to manage documents while maintaining compliance with ISO 13485:2016, EU MDR, FDA 21 CFR Part 820, and FDA 21 CFR Part 11.

自动版本控制、修订控制、电子签名、完整的审计追踪、自动化文档工作流程等功能使您更容易管理文档，同时保持符合 ISO 13485:2016、欧盟 MDR、FDA 21 CFR Part 820 和 FDA 21 CFR Part 11 的要求。

Cloud deployment also ensures that your data is always accessible, backed up, and secure.

云部署还确保您的数据始终可访问、备份和安全。

Streamline Your Document Control Processes With Medical Device Document Control Software 使用医疗器械文档控制软件简化您的文档控制流程

Conclusion 总结

Document control for a medical device company signifies the strategies and methods that are followed for the management of all the documents generated during the lifecycle of a medical device product.

医疗器械公司的文档控制意味着在医疗器械产品的整个生命周期中生成的所有文档的管理所遵循的策略和方法。

With document control, you are ensuring that documents are created, reviewed, distributed, archived, and/or disposed of in a verifiable and organized manner.

通过文档控制，您确保以可验证和有组织的方式创建、审核、分发、归档和/或处置文档。

Traditional document control systems are plagued by many deficiencies, including issues of security, storage, document versions, resource management, accessibility, and compliance.

传统的文件控制系统存在许多问题，包括安全性、存储、文档版本、资源管理、可访问性和合规性等方面的问题。

When you invest in a medical device eQMS solution such as SimplerQMS, your company will streamline and automate documentation processes, eliminate the problems of paper-based systems, and be better prepared for audits and inspections.

当您投资于像 SimplerQMS 这样的医疗设备 eQMS 解决方案时，您的公司将简化和自动化文档处理流程，消除基于纸张的系统的问题，并更好地准备接受审计和检查。

If you are keen on streamlining and simplifying your document management processes, book a personalized demo and talk to one of our quality solution experts to see how SimplerQMS can help you in your document control journey.

如果您有兴趣简化和简化文档管理流程，请预订个性化演示，并与我们的质量解决方案专家之一交谈，了解 SimplerQMS 如何帮助您在文档控制过程中。