If your company is in a highly regulated industry—including pharma, medical devices, biotech, biologics, or CROs—you have to decide how to approach FDA 21 CFR Part 11 compliance for the control of audits, system validation, audit trails, eSignatures, and software documentation. Implementing an effective document management process isn't simple in the age of HIPAA, Part 11, and other compliance requirements.
One option, of course, is to skip Part 11 completely by using paper. But, in the long term, paper-based processes hold a higher risk for your organization than a technology-based approach to data management. Paper-based documents require significantly more time, energy, human resources, and other resources for maintenance and upkeep. They're easier to lose and can become damaged. It's nearly impossible to communicate and collaborate with a global workforce using paper-based systems. A paper-based quality management system may not guarantee quality.
A compliant Document Management System should be a top priority for your organization if you want to minimize risks. Today's best software for organizations who are required to comply with Part 11 can simplify system requirements by providing the required documentation and validation support. In this post, you'll learn how to identify the best Part 11 compliant Document Management Systems, and four options to consider.
What Are Part 11 Compliant Document Management Systems?
A Part 11 Document Management System is software which simplifies compliance with all requirements of FDA 21 CFR Part 11 regulations for system implementation, electronic records keeping, and electronic signatures. The system should simplify FDA requirements for a risk-based approach to validation and revalidation after significant changes are made with support and ease compliance by offering frequent updates per evolving regulations.
An organization can meet the compliance requirement of FDA 21 CFR Part 11 in several ways, including a paper-based approach, a Document Management System designed for use across industries, a Document Management System designed specifically for Part 11 compliance, or a Quality Management System software with compliant document management features.
In general, organizations can achieve greater value out-of-the-box with less customization by selecting an application designed to fit the use case. For example, a Software as a Service (SaaS) solution designed for compliance at pharma companies could require less intensive implementation design and offer lower lifetime maintenance costs than a more general, or open-source alternative.
A Document Management System designed to help an organization maintain compliance with Part 11 is likely to include all of the following features, which may be part of an ISO and FDA-compliant software suite for total quality management:
- Electronic Signatures
- Audit Trail
- Standard Operating Procedures (SOPs)
- Work Instructions
To learn more about how a comprehensive solution can transform your organization, we recommend 13 Bottom Line-Boosting Benefits of a Quality Management System.
DocStar Enterprise Content Management (ECM) is a robust solution designed for the content and document management needs of large organizations. DocStar offers premises-based implementations for organizations seeking a legacy solution but focuses primarily on offering cloud-based deployments for organizations seeking a mobile-friendly solution for global content access from any device. Features include support for multiple file types, metadata, document versioning, collaboration, and form creation.
It may be a particularly strong choice for non-FDA-regulated organizations transitioning from paper-based Document Management Systems by scanning a large volume of documents.
- Compliant with HIPAA requirements for Private Health Information (PHI) Handling
- Offers integration with other enterprise software and systems
- Easy search functionality based on metadata
- Accommodates multiple document types
- Customizable, including flexible workflows, forms, and access permissions
- Not designed specifically for Part 11 compliance
- Extensive configurability requires strong implementation planning
- Online user reviews report security and user management is complex and "inflexible."
- Will require validation and re-validation to comply with FDA regulations
DocStar ECM pricing is not publically available, and interested organizations are encouraged to contact the software vendor directly for a custom quote. User reviews on G2 crowd indicate that the pricing model is based on usage, including a fee charged for every custom form and paying per hour for support.
MasterControl is a document control software system which ensures process consistency, change control, and audit trails in compliance with several FDA CFR 21 Part 11 requirements. The document management portion of this software is one of several offerings available from this vendor, who also provide products for pharma companies in clinical trials and a comprehensive quality management system (QMS software) suite.
Several customer reviews of MasterControl QMS addressed document management features, functionality, and overall customer experience with the product.
Core features include routing, web-based delivery, collaboration, audit trails, reporting, and a validation-ready product. According to G2Crowd data, MasterControl customers include primarily mid-sized and large organizations in highly regulated industries—including pharma, biologics, devices, and law.
- Document control can be implemented as part of a comprehensive QMS suite
- Extensive configuration and customization potential
- Simplifies FDA compliance with audit-ready documentation features
- Users report high-quality collaboration features for document review
- Customers report the cost is exceptionally high for small-to-midsized firms
- Users report a steep learning curve and time-consuming setup
- Limited in-person training opportunities for system administrators
- Users report limited search functionality
MasterControl does not provide pricing data on the website, stating the cost of the product can vary depending on the features purchased, implementation, validation, and support needs. User-generated pricing data on G2Crowd indicates MasterControl is in the 99th percentile for cost among comparable QMS solutions.
eFileCabinet is a widely adopted solution for document management in the enterprise sector, with a self-reported global user base of 155,000 individuals. The vendor offers a suite of solutions for document control and collaboration, including products which support the search, sharing, and storage of "valuable and confidential" data. According to the vendor, built-in security features support compliance with several common regulations, including HIPAA, SEC, and FINRA.
eFileCabinet is not a comprehensive quality management system, and it's not explicitly designed for FDA compliance. However, it includes many features which can support FDA 21 CFR Part 11 compliance, including audit trails, access permissions, and “the ability to validate” the system. No user reviews available on G2 Crowd were created by individuals at organizations identified as FDA-regulated.
- Robust data security and highly customizable user permissions and roles
- Extensive configurability, including custom forms and workflows
- Extensive vendor-provided library of on-demand training resources
- Easy-to-use search
- Support for process automation and template creation
- Not designed specifically for Part 11 compliance or comprehensive quality management
- Users report occasional issues with slow data retrieval
- Customers report limited collaboration functionality
- Limited support for rare document types, including .pcb, and .dxf files
eFileCabinet offers flexible and transparent pricing based on a common SaaS model, which is billed monthly per user license. The costs for comprehensive "business" features is $55 monthly per user, which is charged annually and up to 5TB of storage. A small organization with 20 users could expect to pay $1100 per month. According to eFileCabinet, these costs do not include separately billed features, such as integration, workflow automation, administrative functionality, data conversion, or extended data storage.
Qualio (that's us!) is the first cloud-based QMS software designed under FDA and ISO guidelines for organizations in pharma, therapeutics, devices, and other FDA-regulated industries. Qualio is built for compliance with FDA 21 CFR Part 11, 21 CFR Part 820, ISO 13485, and ISO 14791. Designed specifically for the needs of small-to-midsized FDA-regulated firms, Qualio offers comprehensive QMS and document management features which can scale as an organization grows.
Qualio eQMS software is centered around robust document management features, including FDA Part 11-compliant eSignatures, a template engine and a simple web-based interface for creating and editing documents on any internet-connected device. The document management features are fully integrated with features for compliant training, CAPA, streamlined product development, audits, and more.
- Designed for compliance with Part 11, Part 820, and ISO standards
- Automate quality with links between document management and quality management
- Validation and re-validation ready with strong vendor support
- Updated frequently under global compliance best practices
- Provides extensive support for multiple document types and metadata tagging
- Flexible configuration and security options
- Designed specifically for small-to-midsized organizations in FDA-regulated industries
- Implementation support and training may be required
Qualio pricing is based around a simple SaaS model and organization size. The pricing tiers range from $850 a month for startups and small businesses to $7,500 per month for the enterprise, billed annually. All Qualio customers can gain access to concierge onboarding, professional services, and content packages. Data storage is unlimited with Qualio.
Ensuring Part 11 Compliance
The right document management solution can simplify compliance with Part 11 and serve as a platform for quality-driven growth throughout the organization. While using a technology-based system for document management carries the requirements of system validation and revalidation, the risks of a paper-based approach to document management are significant and prohibitive for most FDA-regulated firms.
By selecting a document management software built for FDA compliance, or a solution which integrates document control and eQMS, your organization can significantly simplify your transition to a culture of quality.