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Electronic Document Management Software (EDMS)

FDA regulations, ISO quality standards, and similar requirements help ensure the quality and efficacy of, not only life science products, but all manufactured products that are subject to industry regulations. Successful implementation of an effective and proven electronic document management software (EDMS) system can immensely simplify compliance with regulatory standards.

There is currently a wide range of electronic document management systems offered by many providers that vary greatly in terms of simplicity or robustness. The key is finding the EDMS system that is the best fit for your organization's electronic document management software needs.

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Product Information

Discover how MasterControl Document Software can manage your document process, all while mitigating risk, improving speed-to-market, and generating ROI.

Product Data Sheets
Product Data Sheets
  • The MasterControl Documents™ software solution automates and effectively manages the document control process to help companies ensure compliance with regulatory requirements. It automates all document routing, delivery, escalation and approval processes and makes the search for and retrieval of documents easy during audits or inspections.
  • Regulatory compliance requires collaborative work at all levels of an organization. By automating, simplifying and optimizing the collaboration process in documents-based projects, MasterControl Collaboration™ allows companies to efficiently bring people together to share their knowledge.
  • Regulatory compliance requires collaborative work at all levels of an organization. By automating, simplifying and optimizing the collaboration process in documents-based projects, MasterControl Collaboration™ allows companies to efficiently bring people together to share their knowledge.

Demos & Toolkits

Get in-depth, comprehensive resources to guide development of your Document Control program

Product Data Sheets
Interactive and Live Demonstrations
  • The MasterControl quality management system (QMS) delivers a wide range of software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management, and more based on your business needs. This overview demonstration shows how MasterControl's QMS eliminates waste, simplifies audits, and facilitates compliance with regulatory guidelines.
Product Data Sheets
  • MasterControl's experts have invested more than 300 hours into the development of this Document Control Toolkit that provides all the materials a company needs to start on the path to establishing a streamlined, robust document management system. Includes 3 videos, 3 white papers, 2 data sheets, and 1 interactive graphic.

Educational Materials

Get insider information about the most relevant issues in Docuemnt Control Software today, and how to navigate and overcome the complexities of FDA and ISO compliance.

Product Data Sheets
White Papers
  • Learn how automated document control solutions help organizations better manage corrective and preventive actions (CAPA), change control, training, and many more quality processes. It foces on document control processes within the quality system lifecycle and provides insight into the capabilities needed to automate change control processes that will increase efficiency, ensure compliance with regulatory requirements and improve overall profitability.
  • Is your document control process like an obstacle course on the road to successful product launch? It doesn't have to be. This white paper discusses the most common issues experienced in each of the five stages of the document control process, and offers tips to overcome them based on real-world insights gleaned by the author from more than a decade of firsthand experience.
  • This white paper shows how medical device developers can better manage all the documentation required for a product launch. It explores ways of reducing the documentation burden and accelerating overall project timelines by taking advantage of the technology offered by Web-based document management systems.
  • This white paper discses common challenges pertaining to document control encountered by most drug companies from the preclinical stage through the post-market phase, and how the MasterControl document management software solution addresses such challenges to accelerate time to market and improve product quality.
Educational Materials
  • Since 2000, we have benefited from a technology-driven era in regulatory compliance. This e-book identifies 16 laws and initiatives that have helped spur such modernization. It explores how the use of technology in the past decade has helped both sides of the fence—regulated companies and regulatory agencies—in easing the pains and costs of compliance.

The most important fact to keep in mind is the recognition that the regulatory compliance of an electronic document management software system is an ongoing state, not a one-time event. With that in mind, the organization will also have to assess other crucial factors before implementing an electronic document management software system, such as: file location and retention, document retrieval requirements, level of security needed, recovering documents in case of disaster, archival needs, workflows, document creation criteria, tracking, and so forth. Every organization has its own document management needs, but there are a variety of EDMS systems available that can meet those needs.

The MasterControl EDMS System: Compliant, Connected, and Complete

Since 1993, MasterControl Inc. has been a leading global provider of electronic document management software. MasterControl's electronic document management software is integrated as well as extraordinarily easy to use. The MasterControl EDMS system keeps companies compliant, connected, and complete, year after year.


With MasterControl's electronic document management software, companies are able maintain a constant state of readiness for inspections and audits. Key compliance features include:

  • Electronic document management software automates document routing, escalation, and document approval
  • InfoCard metadata is linked directly to documents
  • Document change control facilitates and tracks all changes to a document
  • Analytics and reporting functionality


The electronic document management software from MasterControl connects with other quality processes to ensure efficiency and continuous improvement. MasterControl's EDMS system provides:

  • A web-based platform
  • Integrated quality management (CAPA, deviations, nonconformances, etc.)
  • Integration with other applications such as employee training, BOM, supplier management, etc.
  • Graphically linked organizers


The electronic document management software system from MasterControl is supported by time-tested implementation, validation, and product training techniques for a faster ROI. MasterControl's EDMS also comes complete with thorough product training and the highest caliber of technical support.

Visit MasterControl's Resource Center

To learn more about electronic document management software, as well as FDA regulations and ISO requirements, visit the MasterControl Resource Center. There you'll find helpful, industry white papers on electronic document management software, MasterControl EDMS product data, question and answer articles, and more.

For More Information on Document Control Software Systems

For additional details about the Document Control Software Systems from MasterControl, please feel free to contact a MasterControl representative.