FDA Document Control Software

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

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.

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.