Enterprise Content Management (ECM) Software System
Comply with FDA Regulations and ISO Standards with an Enterprise Content Management (ECM) Software System
FDA regulations and ISO quality standards have specific rules when companies choose to establish an electronic document control system to ensure product quality and safety. Making sure your company meets these regulations and standards is possible with a MasterControl enterprise content management software system.
Our ECM software helps ensure that production processes and methods are all pre-approved and that any change in these processes are restricted to authorized personnel and tracked for future review. Despite the underlying importance of content management and control, many companies continue to rely on paper-based and partially electronic document control systems that are plagued by inefficiency and errors that could cause FDA-483 citations or ISO nonconformance.
Converting a paper-based document management process to an electronic process may be challenging, but it ultimately helps eliminate common errors that could lead to serious regulatory problems. This challenge of eliminating errors from the document management processes can be easily met with an enterprise content management software system.
MasterControl's enterprise content management systems is all about providing companies with the facility of standardizing SOPs and bringing conformity in the system. The web-based repository is a centralized location that provides access to all authorized users through secure passwords. The main purpose of the enterprise content management software is to manage all kinds of documentation and help users collaborate in creating and updating documents in a secure environment. MasterControl's ECM software provides a platform through which authorized users communicate with each other and align documentation in accordance to business procedures. This helps in eliminating the excess time it takes in sending out memos and requesting face-to-face meetings used for updating and reviewing documents.
MasterControl's ECM software is all about providing ease to the users with a simple designed interface that aids in conducting quick search and retrieval of documents. Incorporating an ECM system implies better control and reduced costs. For any company to own a successful business, it is important to rely on a system that enhances productivity in the long-run. Paper-based or hybrid solutions can be cost-effective and manage company's SOPs, but eventually they present many problems such as difficulty in search / retrieval of documents, lack of security, miscommunication, waste of time for employees, etc. This is where MasterControl's enterprise content management software steals away the spotlight by providing an online centralized database that conforms to FDA and ISO regulations. It is fully capable of managing, controlling and maintaining your SOPs and aligns all your business procedures without any hassle.
How can MasterControl's Enterprise Content Management Software System Benefit You?
MasterControl's ECM software system is an integrated part of the quality management suite, automates electronic document management processes in an efficient and cost-effective manner. Here are some of the features and benefits of implementing an electronic document management software solution:
Revision Control: An Enterprise Content Management Software System provides automatic document revision control for the enterprises to ensure that only the current version of a standard operating procedure SOP is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every electronic document), the user must enter a reason for the change. The software tracks all changes made to the InfoCard.
Solid Audit Trail: Provides a secure, time-stamped audit trail exceeding 21 CFR part 11 requirements. MasterControl documents the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes made.
ECM Software System Security: 21 CFR Part 11 emphasizes security practices that limit access to authorized users in an enterprise and holding them accountable for written policies. With MasterControl's Enterprise Content Management Software System, an electronic document is stored in virtual vaults located in a central database for access by authorized users only. The software automatically locks both login and approval anytime either one is compromised.
Advanced Tracking: MasterControl's ECM Software System tracks documents by status or history. A document will show as either "in process" or "complete" if tracked by status. The revision or approval history of electronic documents can also be reviewed using the history feature.
Analytics and Reporting: MasterControl's electronic document management system uses advanced analytics and reporting capabilities in the form of standard and customized reports to help increase management oversight.
Electronic Sign-offs: In an ECM system, electronic documents can be signed and approved in an automated fashion. Electronic signature manifestation - name, date, time, and meaning of electronic signature - can be appended automatically to each document.
Manage Different Document Types: MasterControl's electronic document management system is uniquely qualified to be the focal point of any compliance initiative because it can manage different documents-based processes and handle all types of electronic documents regardless of the software used to create them.
Easy Access: Our Enterprise Content Management Software System is web-based so it can connect all employees involved in document and quality control from virtually anywhere. An ECM system provides a centralized repository for easy access, search, and retrieval of electronic documents by all authorized users.
Automates Routing, Escalation, Approval: Reduces document cycle time by automating routing and approval and incorporating escalation for overdue tasks.
Dependent Routing: Completion of a task can be made dependent on another task to give managers more control and reduce cycle time by prompting users immediately to their next task.
Our ECM Software Streamlines Collaboration: Creating and revising documents as a team is easier because MasterControl provides a collaboration workspace that allows a user to see other people's input, avoiding duplication. A rejected document is automatically returned to the originator for a new task, so rejected packets don't languish in the system.
Integrates with Other Applications: MasterControl's enterprise content management system can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.
Pre-Defined Workflow: Company-wide policies, SOPs, and other electronic documents that require inter-departmental collaboration move along a pre-defined workflow, from one department to the next. Overdue tasks automatically escalate to a manager.
Automation of Forms-Based Processes: Form processes unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be integrated with document-based processes under one secure repository. A department can keep the look and function of existing forms or create entirely new ones.
Easy to Search: A standardized "Google-like" search window is available throughout the application, which means all authorized users throughout the organization can search for tasks, training records, policies, and other documents using a familiar search interface in our ECM system.
Easy to Find: MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Every department can maintain its own Organizers and documents can be stored in multiple Organizers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.
To Learn More About Enterprise Content Management (ECM) Software Systems
To learn more, please visit our Resource Center to download additional white papers, webinars, and product data sheets, or you can call a representative about MasterControl's ECM software systems.
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.