Document control vs. document management : the difference

Managing information effectively is crucial for any organization’s success. Two key aspects of information management are often discussed but commonly misunderstood: document management and document control. While they may sound similar, each plays a unique role in how businesses organize, secure, and utilize their critical documents. This blog will explore the differences between document management and document control, delve into the advantages of each system, and highlight how implementing both can enhance operational efficiency and compliance in your organization. 

What is document management?

Document management involves the processes and systems used to receive, track, manage, and store documents within an organization, ensuring that documents are secure, easily accessible, searchable, and manageable. Before digital solutions existed, companies used physical filing systems involving file cabinets, folders, and manual indexing. Documents were stored in dedicated rooms or cabinets and managed through physical logs. With the introduction of electronic management, companies began using spreadsheets and databases to track the location and status of physical documents. Then, documents were often stored on shared drives within a company’s local network, and version control was managed manually by saving different versions of documents with new filenames. 

In the context of Software as a Medical Device (SaMD), this might include the management of software development documentation, user manuals, and clinical trial data. It often involves software that helps in organizing digital documents such as PDFs, word files, and spreadsheets. For example, a SaMD company might use document management systems to maintain a searchable repository of software design documents and testing protocols, ensuring that updates are seamlessly integrated and that historical versions are preserved for audit trails and regulatory review.

Key objectives of document management

The primary goals of document management are to streamline the organization, storage, and retrieval of documents, enhancing efficiency and reducing administrative costs. Key objectives include efficiently organizing the document lifecycle from creation to archiving, securely storing documents, managing access rights for ease of retrieval, classifying and making documents searchable for better usability, and enabling collaborative exchanges. 

Additionally, document management systems classify and make documents searchable, facilitate collaborative exchanges among development teams, and preserve old versions and legacy documents for auditing and compliance purposes. 

Advantages of document management

There are many advantages for the Software as a Medical Device (SaMD) industry when it comes to document management, where regulatory compliance, efficiency, and collaboration are crucial. By streamlining the organization, access, and sharing of critical documents, companies can accelerate development cycles, reduce costs, and ensure compliance with strict industry standards. These capabilities are essential not only for fostering innovation in a competitive market but also for maintaining the integrity and reliability of Medical Devices That directly impact patient care. Here are three big advantages of managing documents well:

Enhanced document accessibility

Well-organized document management ensures that information is easily accessible to those who need it. Efficient indexing and search capabilities allow employees to locate necessary documents, reducing downtime and enhancing productivity quickly. This is particularly vital in fields like SaMD, where accessing accurate and current documentation can directly impact development timelines and regulatory compliance.

Operational cost savings 

Effective document management helps reduce costs in several ways. Companies save on real estate and maintenance expenses by minimizing the need for physical storage space. Additionally, digital document management reduces the need for paper, printing, and associated supplies. Streamlined processes and reduced redundancy also mean that employees can focus more on core business activities than administrative tasks.

Streamlined team collaboration

When documents are managed well, collaboration becomes more straightforward and more effective. Team members can work together seamlessly, with real-time updates and shared access to documents. This is essential in environments where projects are complex and require the input of multiple stakeholders, such as in the development and testing of SaMD products. Effective document management ensures that all team members are on the same page, literally and figuratively, which helps prevent errors and speeds up project completion.

What is document control?

Document control is a subset of document management focused specifically on managing the lifecycle of documents necessary for compliance and formal communication. It involves ensuring that documents are reviewed, approved, updated, and archived according to strict standards and procedures. Document control is a vital aspect of document management that focuses on the security and credibility of maintaining documents within an organization. This practice involves detailed oversight of both current and previous versions of documents to ensure consistency and accuracy. Key processes in document control include version control, which manages iterations of a document; reviewing documents to ensure they meet the required standards, and developing and maintaining a robust approval process. Additionally, regulating document submission and maintaining document security is crucial to protect sensitive information and ensure that documents are handled appropriately.

Document control aligns with and adheres to global standards such as ISO 9001 and ISO 13485, which are particularly important in regulated industries like SaMD. A well-implemented document control system not only controls how information, people, and processes interact but also ensures the highest quality outcomes for products. The cornerstone of an effective document control system is a comprehensive document lifecycle model that leverages digital tools to manage documents from creation through archiving, ensuring that every step of the process is traceable and under control.

Key objectives of document control

Document control encompasses several key objectives essential for ensuring the integrity and reliability of organizational documents. These key objectives collectively form the cornerstone of effective document control practices, supporting organizational efficiency, regulatory compliance, and quality assurance. The key objectives are: 

Compliance - Ensuring documents adhere to regulatory requirements and standards.
Traceability - Maintaining records of document changes and access to facilitate audits.
Security - Protecting sensitive information from unauthorized access or alterations.
Consistency - Ensuring all documents are up to date and consistently formatted.

Advantages of document control

Document control is indispensable for companies navigating the intricate landscape of regulatory compliance, quality assurance, and operational efficiency. By implementing robust document control systems, you ensure meticulous management of critical documents, from design specifications to clinical trial data, following industry-specific regulations such as those mandated by the FDA or EU MDR. These systems provide an auditable trail of document revisions and approvals, enabling companies to demonstrate compliance during audits and mitigate legal risks. Here are three big advantages of document control:

Regulatory compliance

Document control is vital for SaMD companies to meet industry-specific regulatory requirements, such as those set by the FDA or EU MDR. These systems ensure that critical documents, from design specifications to clinical trial data, are managed in compliance with these standards. By maintaining an auditable trail of document revisions and approvals, document control helps companies demonstrate compliance during audits, reducing legal risks like fines or product recalls. In essence, document control systems play a crucial role in ensuring regulatory compliance and minimizing legal liabilities in the SaMD industry.

Quality assurance

Document control enhances the reliability of documents and thereby improves overall product quality. This ensures accurate management of critical documents, including design specifications and testing protocols, preventing errors and inconsistencies that could compromise product integrity. By enforcing strict version control and providing a single source of truth for documents, document control systems promote consistency and uniformity in product development and testing processes. This standardized approach mitigates the risk of errors and deviations, resulting in more reliable and high-quality SaMD products. 

Reduced duplication

Reducing duplication is a key advantage of document control in the SaMD industry, as it limits redundancy and ensures that only the most current documents are in circulation. Document control systems streamline the management of documents, preventing the proliferation of multiple versions and outdated copies. By enforcing strict version control and providing centralized access to the latest documents, these systems eliminate the need for duplicate files and ensure that all stakeholders have access to the most up-to-date information. This not only reduces confusion and errors but also promotes efficiency and productivity by eliminating the time wasted searching for the correct version of a document. 

What is document management vs document control?

Document management and control are closely intertwined, making it challenging to prioritize one over the other. A controlled document inherently falls under document management. Although it's possible to manage documents without implementing controls, it's relatively uncommon, particularly in a business context. The primary distinction between document management and document control lies in their scope and emphasis. Document management encompasses all organizational documents, whereas document control focuses on specific documents that necessitate regulated handling for compliance and official records.

Importance of implementing both document control and document management

Implementing both systems ensures comprehensive management of all organizational documents while also addressing specific needs for controlled documents. This dual approach enhances overall efficiency, compliance, and security across all levels of an organization.

Automate Processes: Automates workflows for review and approval processes.
Enhance Compliance: Provides tools to maintain compliance with both internal standards and external regulations.
Centralize Document Handling: Offers a centralized platform to manage, control, and audit all documentation.

MatrixALM offers a centralized platform to manage, control, and audit all documentation and includes robust storage capabilities. All documents are securely stored and easily accessible when needed. Our advanced document workflow control features, including review and approval processes, streamline document handling and enhance collaboration among team members, and include electronic signatures that are Part 11 compliant. 

Additionally, our systems maintain detailed audit trails with a full activity history, providing transparency and accountability throughout the lifecycle. We also offer unique IDs and powerful search functionalities, making it effortless for users to find the exact document they need amidst vast repositories of information. Security and access protocols are prioritized to safeguard sensitive data, ensuring compliance with regulatory standards and protecting against unauthorized access. Moreover, our templates facilitate standardized document creation, saving time and ensuring consistency. 

To learn more about how Matrix Requirements empowers Software as/in a Medical Device (SxMD) companies to manage and control their documents contact us to request a demo with a product expert who can show you how Matrix Requirements can optimize efficiency and compliance for your business so you can get your Medical Device to market faster.