FDA Document Control Software

Compliance with FDA Regulations is the Cornerstone of any FDA Document Control Software System

The FDA requires pharmaceutical, biotechnology, medical device, laboratory, and other life science companies comply with 21 CFR Part 11 if they use quality and document control software. Apart from the peace of mind that comes from knowing you can pass an FDA inspection of your software systems, having MasterControl's FDA document control software also makes your job easier by automating the tasks of document tracking, approvals, collaboration, version / revision control, and ensuring only approved documents are available for use.

Reducing the Documentation Burden in FDA Design Control

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Benefits of MasterControl's FDA Document Control Software System

  • Streamlined FDA inspection process (FDA auditors are familiar with our system)
  • Efficient processes help control documents with less effort and stress
  • Automatic routing and escalations means less time tracking down signatures
  • Automatic version control and archiving means you don't have to keep paper binders or worry about rogue documents
  • Scheduled reports and dashboards frees you up to focus on other tasks

Why is MasterControl's FDA Document Control Software Right for You?

MasterControl Documents, an integrated part of the MasterControl quality management suite, automates and manages fda document control processes in an efficient and cost-effective manner. Here are some of its robust features to ensure your system is always Compliant, Connected, and Complete:

Compliant FDA Document Control Software

Sustained Compliance: MasterControl Documents is a compliant 21 CFR Part 11 FDA document control software that helps all departments in FDA-regulated companies control their SOPs and other document control processes. It helps sustain compliance by keeping the quality system constantly prepared for FDA inspections and quality audits.

  • Version & Revision Control: automatic revision control and version control is provided to ensure that only the current version of a document is available. Old documents are automatically archived to avoid unwanted access.
  • Solid Audit Trail: provides a secure, time-stamped audit trail exceeding 21 CFR 11 requirements. The system documents the identity of anyone who creates or modifies an electronic record, when the action occurred, and who approved the changes. There are a number of additional change control options to record what changes were made.
  • Security: 21 CFR 11 emphasizes security practices that limit access to authorized users and holding them accountable for written policies when using FDA document control software. With MasterControl, documents are placed in virtual vaults, controlling them to ensure access by authorized users only. The system has separate password protection for both login and approval, and will automatically lock both if either one is compromised.
  • Status Tracking: MasterControl can track 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 documents can also be reviewed using the history feature.
  • Analytics and Reporting: advanced reporting analytics give canned and customized reporting options for all data in the system to ease management oversight.
  • Electronic Sign-offs: With MasterControl, documents can be signed and approved electronically. Signature manifestation name, date, time, and meaning of electronic signature can be appended automatically to each document.

Connected FDA Document Control Software

Integrated Quality Management: MasterControl Documents connects quality processes under a single Web-based platform to promote the continuous quality improvement you would expect from a FDA document control software system.

  • Manage Different Files and Document Types: MasterControl understands that not every document is created equal. MasterControl can accept, store, and provide control to any type of electronic file. Once stored, you can control through permissions if users can access the file as a PDF (in most cases) or in it's native application.
  • Easy Access: as a web-based solution, all employees involved in the quality process can connect from virtually anywhere. Our FDA document control software provides a centralized repository that makes it easy for all authorized users to search and access the necessary documents.
  • 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.
  • 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.

Complete FDA Document Control Software

Enterprise-wide Application: MasterControl's quality suite, which includes the FDA document control module, can meet every department's needs to ensure that quality initiatives are enforced across the enterprise.

  • Integrates with Other Applications: MasterControl is made to integrate with other applications like ERP, LIMS, and accounting software so that information can be shared to accommodate departmental needs.
  • Pre-Defined Workflow: Company-wide policies, SOPs, and other 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.
  • Easy to Find: MasterControl's Explorer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Every department can maintain its own Explorers and documents can be stored in multiple Explorers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.

For More Information on FDA Document Control Software

Please feel free to contact us for additional information on our FDA document control software system.