Document control software improves regulatory compliance

Improve compliance, reduce risk, and enhance process management with document control software.

Document control software is essential for managing regulated content where quality and compliance are required. A document control system can help you manage information and files in compliance with regulations and standards like ISO, FDA, Sarbanes-Oxley, and more.

Learn more: What is document control?

With document control software, you can automate records management policies, control access to information, and secure a complete history of all document activity for auditing and submissions. Wherever information management must comply with regulations and policies, best practices for document control will help avoid risk of penalties and fines.

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Paperless document control software

Replace paper-based document control procedures with an electronic document control system that speeds the routing and retrieval of information, automatically captures document versions, and improves auditing with an electronic audit trail. Electronic document control software converts paper-based document control procedures to paperless.

Automate document control procedures

Enact procedural and administrative controls that improve the efficiency of business processes with notifications and approvals. Manual interactions are replaced with automated steps that improve the flow of information and increase accountability.

Benefits of document control software

• Automate document control procedures to comply with regulations like FDA 21 CFR Part 11, ISO standards, and more.
• Manage quality documents like CAPA, SOPs, non-conformance reports, training, work instructions, and more.
• Define and manage records policies.
• Capture an electronic audit trail with history of versions and activity.
• Include email records in document control procedures.
• Analyze standard and customizable reports.
• Convert paper to full-text searchable digital files.

Document control for FDA 21 CFR Part 11

Document control provides effective pharmaceutical document control for the structured management of regulated content across Research and Development, Operations, and Marketing at biotechnology and life sciences companies.

• Easy search and fast document retrieval
• Secure document archiving and audit trail
• Protocols, methods, and test record controls
• Conversion of paper to full-text searchable digital files
• Automation of workflow processes
• Scanning of case and research file archives directly into the repository
• Partner collaboration

Document control solutions for quality management

Document control is essential in the success of quality management. Quality documentation like CAPAs, SOPs, non-conformance reports, employee training, and work instructions are managed within a document control repository that provides for version tracking, approvals, notifications, policy administration, and more.

Advanced features of document control software

Document Control Workflow

Fully-customizable document workflows with notifications, approvals, and logging of activity history.

Reporting

Analyze document and process trends with integrated reporting.

Auditing

Record a history of access, changes, and approvals in the document control system with audit logging.

Document Version Control

Records a history of all changes using document version control, and manages access to version history.

Electronic signatures

Facilitates digital signatures from within the document control system via integrations.

Security

Security settings manage access within the document control system.

Document Imaging

Document scanning digitizes and manages paper files, electronically.

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