Document Control Software Systems

Document control is an essential requirement in regulatory environments, touching all quality processes. It is a major stumbling block for many companies. MasterControl's document control software addresses the world's most stringent regulations and standards to ensure compliance. It reduces overall compliance cost and increases efficiency to accelerate time to market.

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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.
  • Change is the only constant in quality management, as in life. In FDA and ISO environments, the key is to manage the inevitable changes that occur for the sake of improving product quality and safety, and to ensure compliance. MasterControl Change Control™ automates every step of the change control process and keeps your quality system in a state of constant audit- and inspection-readiness.

Toolkits & Demos

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
Toolkits
  • 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 Document Control Software today, and how to navigate and overcome the complexities of FDA and ISO compliance.

Product Data Sheets
White Papers
  • 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.
  • 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.
  • 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
E-Book
  • 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.


Choose the Document Control Software Trusted by Life Science Industry


Life science companies and regulatory bodies trust MasterControl:

MasterControl's document control system was designed by industry professionals who have walked in your shoes and understand the unique challenges of your industry.

The company's successful software implementation and validation track record in over two decades has earned customer trust and confidence as reflected by a 97 percent customer retention rate.

Document Control Challenges

MasterControl Document Control Software System


Inefficiency

Manual systems are inefficient, requiring tremendous man-hours in terms of routing documents, obtaining approval and signatures, face-to-face meetings to discuss changes, and search and retrieval of documents during inspections and audits.


Increased Efficiency

MasterControl's document control software automates routing, delivery, escalation, and approval of documents. It can handle all types of documents regardless of the software used to create them. MasterControl features a centralized, secure repository that makes search and retrieval easy.


Lack of Revision Control

In a paper-based system or hybrid system, employees check out documents and other materials manually. Tracking down any document activity is difficult. Making a change in SOPs or other documents requires manual submission of a change request or discussion of the change in face-to-face meetings.

Automated Revision Control

MasterControl provides automatic revision control to ensure that only the current version of a document is available. When the new revision becomes effective, access to the prior revision is cut off. The system allows you to lock down uncontrolled copies and track controlled copies.


Disparate Systems

Most companies have different systems for document control, CAPA, audit, training, and other processes. They are not connected. The people who manage these separate processes are not connected, increasing the likelihood of miscommunication. Tasks are likely to fall through the cracks from one disparate system to another.

Connected System

In MasterControl's integrated system, document control is connected to other processes for a seamless quality management. For example, if an important SOP has changed significantly so as to merit a retraining, the system will automatically launch training tasks to affected employees once the revised document becomes effective.


Unprepared for Audits

All important documents related to the development and manufacture of a product are subject to audits and inspections. In a manual process, paper documents are hard to track and can be easily misplaced. There's nothing worse than failing to produce an important document during an audit.

Increased Audit Preparedness

MasterControl Documents provides a centralized, web-based repository for all documents essential to compliance. Auditors will need to look at only one place for anything they need. Automation makes it easier to search, track, and retrieve documents.


Poor Collaboration Process

In a manual process, collaboration entails gathering all stakeholders in one room, which is time-consuming, if not impossible. Some people might collaborate in writing, but routing a document via email is inefficient.

Effective Collaboration Process

MasterControl's virtual collaboration workspace allows users to collaborate in a secure and real-time environment. Authorized users can add their input any time from virtually anywhere, so physical location will no longer cause delays in collaboration.

MasterControl's integration with PleaseReview, a leading co-authoring software, provides control over collaborations and streamlines the process of sending documents between the two systems.


Lack of Visibility

A manual system relies on disparate tools like spreadsheets and flowcharts to generate reports crucial for evaluations and decision making. Without a coherent and reliable reporting system, managers are unable to see the big picture.

Increased Visibility

MasterControl's advanced analytics and reporting capability will help managers monitor quality processes and proactively improve them. It includes dashboard, drill-down, and scheduling features and provides standard and customized reports.



Other Features

  • InfoCard Metadata Linked to Document: This feature helps eliminate a common problem with out-of-sync metadata during the revision process. When revising a Microsoft Word document, updated information such as document number and revision number can be automatically transferred to the document header from the InfoCard, the MasterControl tool that provides basic information about a document.

  • 508 Compliance Skin: Users with visual impairments can turn on the "508 compliance" skin and they will be able to use a screen reader that will go through all the tabs and buttons on a web page, making it easier to select the appropriate tab or button.

  • Translatable System: If you have facilities overseas, MasterControl makes it easier to allow non-English speakers to use the system. You can choose a translatable out-of-the-box documents module. If you choose Spanish, your system will be able to switch to Spanish for your Spanish-speaking divisions and facilities.

  • Autoload Feature: The system allows users to drag and drop new documents into preconfigured network folders, making document creation infinitely easier. MasterControl can even automatically launch a collaboration for the new document or send it automatically on the appropriate approval route.

  • Configurable Workflows: You can automate routing of workflows to the appropriate participants and configure an escalation hierarchy of approvers for tasks that fail to meet timelines.

  • Controlled Copies: Users can create controlled copies with a customizable watermark, sequential number, and location tracking. This feature is designed for companies that need to copy, print, and distribute controlled documents to their manufacturing lines, suppliers, or other locations.

  • PDF Binders: The system can consolidate multiple files into a single PDF for distribution. The binder automatically includes date, time, and table of contents.

  • Record Retention: Based on your company's retention policy, you can configure the length of time a document will last in the system, anywhere from days to years. You can configure retention by document type.

Top 10 Features of MasterControl Documents

  1. Automated Document Control and Management: Automate the entire lifecycle of your documents, from creation to approval, distribution, retrieval, and obsolescence. By automating tasks such as routing, follow-up, escalation, and approval, you will reduce your document cycle time. A streamlined and standardized process will facilitate compliance by making it easy for all stakeholders to participate in the process.

  2. Change Control: You can route different types of changes to the appropriate group of people for an efficient and effective process. Users will be able to track the changes between revisions of an item in the system. Basic change-control tasks such as scheduling reviews, designating reviewers, and sending out reminders to them will be automated.

  3. MasterControl Explorer: This is a powerful tool that allows users to organize documents so that they can be accessed quickly. Users can access files and their associated metadata, designate favorite documents or locations, and export files all within the Explorer interface. The system automatically categorizes and updates the documents.
    • Taxonomy Organizers: MasterControl Explorer enables the same set of documents to be organized in multiple categories so different departments can create a hierarchy tailored to their needs.

  4. Responsive Interface and User-Friendly Navigation: MasterControl's Hub consists of tiles that are easy to view, use, and navigate. The tiles function as menu items that let users access their tasks quickly and navigate to another page and perform other actions. The UI is responsive, which means it will fit the screen you're using, whether it's a desktop computer or mobile device or tablet.

  5. Analytics and Dashboards: MasterControl's advanced analytics and reporting capabilities provide standard and customized reports to help increase management oversight. It includes dashboard, drill-down, and scheduling features.

  6. Part 11-Compliant Features: MasterControl provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA's 21 CFR Part 11 requirements for document control systems. Security features include dual passwords for document approval; password expiration, encryption, and certification; and account lockout to stop unauthorized users from gaining system access.

  7. Virtual Collaboration Workspace: Collaborate with different teams regardless of location and time zone in a virtual collaboration space. You will be able to give system access to external parties, such as consultants and suppliers, for collaboration purposes.

  8. Web-Based Platform: MasterControl is web-based so it can connect all employees involved in document and quality control from virtually anywhere. Authorized users will be able to access the system 24/7.

  9. Document Revision Control: When a new revision of a document becomes effective, access to the prior revision will be cut off and only the current revision will be available. Automatic revision control ensures that users will not make the mistake of using obsolete or unapproved documents. It provides automatic revision history, including reasons for every change, when it was approved, who approved it, and the approver's signature.

  10. Single Centralized Repository: Your users will be able to go to a single centralized location for all documents they need for compliance. Likewise, auditors and inspectors will be able to find documents they need to see in one place.

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.