Why You Should Start with Document, Training and Change Management as The Building Blocks for Your QMS为什么您应该从文档、培训和变更管理入手作为 QMS 的基础

EDMS Before EQMS - Why? 在采用企业质量管理系统（EQMS）之前，为什么要使用电子文档管理系统（EDMS）？

Companies, as part of their digital transformation, embrace Enterprise Quality Management Systems to help migrate from paper based, be-spoke/non-integrated systems to a unified platform providing capabilities to automate key QMS processes across the organization. As such, the question often asked is, which solution(s) should I start with? The typical consultant response would be, “Start with where you believe the maximum pain for the organization is and evolve from there”. This approach makes perfect sense if the focus was to solve a specific problem that the organization faces. However, to effectively implement a new Quality Management system, it is important for an organization to identify and build the right foundation first and then build the rest of the QMS on it. This approach will not only solve the problems that the company faces in the right model but also provide an approach to roll-out a strategy that is sustaining, well adopted and is longer lasting.
作为数字化转型的一部分，公司采用企业质量管理系统来帮助从基于纸张的、非集成的系统迁移到统一平台，提供自动化关键质量管理流程的能力。因此，经常会问到应该从哪个解决方案开始。典型的顾问回答通常是“从你认为对组织造成最大痛苦的地方开始，并从那里发展”。如果重点是解决组织面临的特定问题，这种方法是完全合理的。然而，为了有效地实施新的质量管理系统，组织需要首先确定并建立正确的基础，然后在此基础上建立其余的质量管理体系。这种方法不仅可以在正确的模式下解决公司面临的问题，还可以提供一种可持续、广泛接受和更持久的策略实施方法。

ComplianceQuest strongly recommends the roll-out of Enterprise Document Management System (EDMS) consisting of Document Control, Training and Change Management processes as the foundational capabilities first. The following provides the salient points to consider:
ComplianceQuest强烈推荐首先推出由文档控制、培训和变更管理流程组成的企业文档管理系统（EDMS）作为基本能力。以下是需要考虑的要点：

1.If you work in Quality you probably know that the effectiveness of a Quality Management System (QMS) relies extensively on enterprise-wide collaboration and begins with a solid process for managing critical/important documents, such as standard operating procedures. As rapidly as business and its processes evolve these days, many organizations struggle to stay current in a sea of change. Therefore, it’s not surprising that document management remains at the very top of quality management processes being automated especially within highly regulated industries.
1.如果您从事质量工作，您可能知道质量管理体系（QMS）的有效性在很大程度上依赖于全企业范围内的协作，并始于对关键/重要文档（如标准操作程序）进行管理的坚实流程。随着业务和其过程日新月异，许多组织在变化的海洋中难以保持与时俱进。因此，不足为奇的是，文档管理仍然是自动化质量管理流程的首要任务，尤其是在高度管制的行业中。

2.LNS Research, a leading EQMS focused independent analyst organization, states:
2.作为一个领先的EQMS专注独立分析机构，LNS研究指出：

a.Today, document management is a typical functionality of enterprise quality management software (EQMS). Because many EQMS functionalities require standardized documents and workflows, document management software is a key enabler of closed-loop quality management, the concept of creating cross-functional quality data feedback loops to earlier in the value chain. Specifically, document control plays a noteworthy role in improving the following processes:
a.今天，文档管理是企业质量管理软件（EQMS）的典型功能。因为许多EQMS功能需要标准化的文件和工作流程，文档管理软件是闭环质量管理的关键推动者，该概念是创建跨功能质量数据反馈循环到价值链上游的概念。具体而言，文档控制在改进以下流程中发挥了显著作用：

• Audit

• Change

• Environment, Health, & Safety (EH&S)

• Non-conformance/Corrective and Preventive Action (NC/CAPA) management

• Deviation (Temporary or Planned)

• OOS/OOT

• Supplier Quality

• Compliance

• Employee Training

• 审计

• 变更

• 环境、健康与安全（EH&S）

• 不符合/纠正和预防措施（NC/CAPA）管理

• 偏差（临时或计划）

• OOS/OOT

• 供应商质量

• 合规性

• 员工培训
  

b.Quality professionals recognize that conformance and harmonization of an enterprise Quality Management System (QMS) begins with a solid document management foundation. But the reality is, most organizations are drowning in documentation—which is why there’s no surprise that document management remains at the very top of quality management processes that have been automated by organizations. Such capabilities in enterprise quality management software (EQMS) are commonplace, often tightly coupled with training and competence feature-sets, providing an escape from the stagnant and difficult-to-maintain multiple binder, shared directory or 1-dimensional intranet page approach. Four primary considerations:
b. 质量专业人员认识到，一个企业质量管理体系（QMS）的一致性和协调始于一个坚实的文档管理基础。但现实情况是，大多数组织淹没在文档中，这就是为什么不足为奇地文档管理依然是被组织自动化的质量管理流程的首要问题。企业质量管理软件（EQMS）中的此类功能很常见，通常与培训和能力功能集紧密结合，提供了摆脱停滞、难以维护的多本文件夹、共享目录或一维内部网页方法的途径。四个主要考虑因素：

• Speed and ease of access and consumption for document stakeholders

• Ensuring the integrity of documentation

• Automating onerous tasks associated with publishing and distributing documents

• Leveraging for multiple disciplines as a business operating system
  

• 快速和方便地访问和消费文档的相关人员

• 确保文档的完整性

• 自动化与发布和分发文档相关的繁琐任务

• 将其作为多个学科的业务操作系统来利用
  

c.Approximately 47% of companies surveyed by LNS Research indicated that they had adopted an electronic Document Management System (eDMS) to enhance and expedite their quality processes. Clearly, there’s plenty of room for improvement in this area among industries where quality is key. Incessant changes and modifications, combined with industry regulations requiring document management, make it nearly impossible to maintain a structured, accurate quality management system without an automated process.
c. LNS研究调查的约47%的公司表示他们采用了电子文档管理系统（eDMS）来改善和加快其质量流程。显然，在质量至关重要的行业中，在这方面有很大的改进空间。不断变化和修改，再加上要求文档管理的行业法规，使得在没有自动化过程的情况下，几乎不可能维护一个结构化、准确的质量管理体系。

3.Responsible for regulating and controlling crucial systems,processes,functions,and procedures, documents drive nearly every action within a Life Sciences company.By starting with document management when moving to digital,organizations will have a repository of all objective evidence and proof surrounding end-to-end product lifecycle process.Searching for and finding the latest version of documents quickly is key.This is critical for compliance for all Regulatory Inspections and ISO Certifications.
3. 负责调控和控制关键系统、流程、功能和程序，文件几乎驱动着生命科学公司的每一个行动。当转向数字化时，从文件管理开始，组织将拥有有关端到端产品生命周期过程的所有客观证据和证明的存储库。快速搜索和找到最新版本的文件是关键。这对于符合所有监管检查和ISO认证至关重要。

4.Strong document management processes ensure everyone in your organization,regardless of the department or team, knows exactly where a document is housed, which stage it's at in the review process,and has access to documents quickly. A document is useless, if it's not accessible when needed by the people who need them.
4. 强大的文件管理流程确保组织中的每个人，无论是哪个部门或团队，都准确知道文件存放在何处，文件在审核过程中处于哪个阶段，并且可以快速访问文件。如果需要的人无法在需要时访问文件，则该文件是无用的。

5.Documents are on-going living entities continually changing as the organization,process and products change vs.records that reflect history of what has happened.Keeping control of documents in paper-based environment can make this complex in making sure to get all the appropriate reviews and approvals and ensuring employees are using the right version of documents in their job whether in Quality,Manufacturing shop floor,or Customer Service complaint handling.

5. 文件是持续变化的活体，随着组织、流程和产品的变化而变化，而记录则反映了已发生的历史。在纸质环境中控制文件可能会使这一过程复杂化，以确保获得所有适当的审查和批准，并确保员工在其工作中使用正确版本的文件，无论是在质量、制造车间还是客户服务投诉处理方面。