Why use an Electronic Document Management System (EDMS) before adopting an Enterprise Quality Management System (EQMS)?
As part of its digital transformation, the company adopted an enterprise quality management system to help migrate from a paper-based, non-integrated system to a unified platform that provides the ability to automate critical quality management processes. As a result, it is often asked which solution you should start with. The typical consultant response is usually "start where you think is causing the most pain to the organization and grow from there." If the focus is on solving a specific problem facing the organization, this approach makes perfect sense. However, in order to effectively implement a new quality management system, organizations need to first identify and establish the right foundation, and then build the rest of the quality management system on top of that. This approach not only solves the problems faced by the company in the right model, but also provides a sustainable, widely accepted, and more durable approach to strategy implementation.
ComplianceQuest strongly recommends the introduction of an Enterprise Document Management System (EDMS) consisting of document control, training, and change management processes as a foundational competency first. Here are the points to consider:
1.If you work in quality, you probably know that the effectiveness of a quality management system (QMS) relies heavily on enterprise-wide collaboration and starts with a solid process for managing critical and important documents, such as standard operating procedures. As business and its processes evolve at a rapid pace, many organizations struggle to stay relevant in a sea of change. Therefore, it is not surprising that document management remains a top priority for automating quality management processes, especially in highly regulated industries.
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2.As a leading EQMS focused independent analyst firm, LNS Research states:
a.Today, document management is a typical feature of enterprise quality management software (EQMS). Because many EQMS functions require standardized documentation and workflows, document management software is a key enabler of closed-loop quality management, the concept of creating cross-functional quality data feedback loops upstream the value chain. Specifically, document control has played a significant role in improving the following processes:
l Audit. l Changes.
Environment, Health & Safety (EH&S).
l Non-compliance with Corrective and Preventive Action (NC CAPA) management.
l Deviation (temporary or planned).
l oos/oot
l **Quotient quality.
l Compliance.
l Employee training.
b.Quality professionals recognize that consistency and alignment of an enterprise's quality management system (QMS) starts with a solid foundation of document management. But the reality is that most organizations are drowning in documents, which is why it's no surprise that document management remains the top issue for the quality management processes that organizations automate. Such functionality in enterprise quality management software (EQMS) is common and is often tightly coupled with training and competency feature sets, providing a path away from a stagnant, hard-to-maintain approach of multiple folders, shared directories, or one-dimensional internal web pages. Four main considerations:
l Stakeholders who can quickly and easily access and consume documents.
l Ensure the integrity of the document.
Automate tedious tasks related to publishing and distributing documents.
l Leverage it as a business operating system for multiple disciplines.
c.About 47% of companies surveyed in the LNS study said they have adopted an electronic document management system (EDMS) to improve and speed up their quality processes. Clearly, in an industry where quality is paramount, there is a lot of room for improvement in this area. Constant 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.
3.Responsible for regulating and controlling critical systems, processes, functions, and procedures, documents drive nearly every action of life sciences companies. When moving to digital, starting with document management, organizations will have a repository of all objective evidence and proofs about the end-to-end product lifecycle process. Quickly searching and finding the latest version of the file is key. This is essential for compliance with all regulatory inspections and ISO certifications.
4.Robust document management processes ensure that everyone in the organization, no matter which department or team, knows exactly where the files are, where they are in the review process, and can quickly access them. If the person who needs it can't access the file when they need it, the file is useless.
5.Documents are living organisms that are constantly changing, changing with the organization, processes, and products, while records reflect the history that has occurred. Controlling documentation in a paper-based environment can complicate this process to ensure that all appropriate reviews and approvals are obtained, and that employees are using the correct version of documentation in their work, whether in terms of quality, manufacturing floor, or customer service complaint handling.
6.Before addressing electronic document management systems, companies that have made EQMS a top priority have shown that the implementation of EQMS is seen as a partial automation of a specific process, considering that most of the processes related to the problem involve more or less changes to the document or the retraining of the specific resources involved in the handling of the problem.
7. "The documented information required by the quality management system and the international standard ISO 9001 must be controlled. The whole purpose of controlling documented information is to ensure that it is "usable and applicable" while also "protecting" it. Being able to clearly demonstrate the custody and traceability of documents is a regulatory requirement, and an electronic document management system can help us comply with this requirement with audit trails and traceable fine-grained security controls.
8.In the life sciences sector, paper document management and archiving can be time-consuming and expensive due to the long-term retention requirements for regulated content. When moving to an electronic environment, the efficiency of processing, storing, and retrieving documents can be significantly improved. Automated file retention policies improve the archiving process. The need for physical storage space for paper records is also greatly reduced or eliminated altogether.
9.Document content and metadata can represent an important part of a company's intellectual property. Enterprise intelligence and advanced search tools allow metrics and trends to be generated from this data. Being able to easily find information and knowledge in indexed content helps improve decision-making and reduce the time spent searching for information.
10.An effective automated system will integrate documentation and change control procedures. It will also integrate with other solutions to provide access to approved and controlled documents in other areas of the quality system, including audits, corrective and preventive actions, and employee training. In these cases, the search and retrieval capabilities, dashboards, and repositories of automated systems will speed up the process.
11.Operational excellence and compliance rely on accurate data and real-time file management. While the transition from a paper-based or hybrid system to a fully automated system can be a challenging process, recent regulatory and review requirements for product safety have necessitated this transition. Companies that use automated systems report a quick return on investment, driving overall compliance and harmonization of enterprise-wide quality systems through expedited and effective document control.
12.A strong document control process is at the heart of a quality management system. Almost every audit and compliance element is verified by examining documentary evidence. This is a basic requirement for regulatory inspectors, so in order to remain compliant, you need to keep your organization's documents fresh and available.
13.The demand for the use of contract manufacturers is growing, and today's business relationships are expanding in terms of global scope and complexity of materials and components. Therefore, it is critical to ensure effective collaborative workspaces and version control to ensure legal, secure, and compliant operations.
14.A well-designed and documented system has many benefits, ensuring that quality standards are met continuously, minimizing the possibility of errors, reducing downtime when deviations occur, as relevant data can be quickly accessed, and allowing processes to be easily monitored to analyze process output and make appropriate adjustments. Quality management system documents fulfill many functions, such as information transfer, providing evidence of conformity, and sharing knowledge, etc., and therefore require many different types and levels of documents, such as quality manuals, quality policies, documented procedures, and work instructions.
15.Documentation also needs to be for regulatory purposes and must demonstrate the effective planning, operation, and control of the organization's processes, as well as the effectiveness of the implementation and continuous improvement of its quality management system. Obviously, good documentation is essential for a well-functioning quality management system, and in fact, it forms the basis of an organization's quality management system, as it has an impact on the quality management system throughout the life cycle of a product service.