IMG 2018 Veeva Banners Document Control

    The Ultimate Guide to
    Document Management

    What is Document Management?

    Document management encompasses the processes and systems deployed to protect the safety and efficiency of information. Managing documents is critical to ensuring the security, efficiency, and compliance of your company’s information.

    Information is the foundation of a business. Properly maintained and secured, it can help a company rise to its greatest potential. But just like a foundation, any faults or oversights can send a business tumbling to the ground.

    For businesses in a regulated industry, having a central, secure document repository with access and version controls ensures that the right people have access to the correct version of each document and an audit trail exists to track changes to each document over time.

    Document Management Dashboard

    History of Document Management

    Document management processes predate the advent of computers. Historically, critical information was written on paper, and filing systems housed all businesses documentation. Though lacking the efficiency of today’s virtual solutions, these large containers kept files safe and organized, but vulnerable to potential loss.

    Early photocopying came about in the late 1930s. Photographs of documents printed onto microfilm served as a way to ensure the safety, longevity, and accessibility of information. The problem remained, however, that physical storage was liable for unauthorized access, modification, or disposal.

    When personal computers became common in the 1980s, modern document control started to form. With the help of servers, the internet, and the efficiencies that computing  brought to business, document control modernized.

    Why is Document Management Important?

    An efficient document management process is an essential part of security, compliance, and efficiency of not only a business's information but the overall operation:
    1. Security

      The proprietary components of your company set you apart and make your business tick. An audit trail is a vital aspect of a good document management system. It is a chronological record that provides written evidence of events and actions taken that affect any aspect of your operation. If your end result falls short, important information is leaked or changed, or document access needs to be regulated, you can easily pinpoint where things went wrong, what caused that breakdown and rectify the situation.

    2. Compliance

      Document management systems aren’t just about keeping information secure. If your business is working in a regulated industry, all documents and procedures must consistently conform to an ever-changing list of rules and standards.

      A document management system, therefore, helps ensure every component of the product is safe and up to standard, not a single statement is misleading or false, and the product is marketed and sold the right way.

    3. Efficiency

      Document management systems ensure an efficient process from start to finish. Though we live in a digital age, many still maintain physical file systems. Paper is not only difficult and time-consuming to access and share, but it also limits opportunities for collaboration and innovation. Digital files even have their share of issues: when shared over email (creating version control nightmares), processes slow to a crawl and team members are more likely to make mistakes due to inaccessible and outdated information. With all documents in one place, in a collaborative and accessible environment, your business can run like a well-oiled machine.

    Team discussing in meeting room

    Document Management Software Solutions

    Integrating a document management system not only protects and preserves your files, but allows your team to collaborate on, access, and share critical information. With a streamlined system, you'll be able to deliver on consumer expectations quickly and accurately without the headache outdated systems cause. 

    Well-implemented Document Management Software enables you to manage your mission-critical content and compliance requirements. On premise document repository or shared drives in the cloud become obsolete. Document Management Software solutions allow you to streamline your critical document and data driven processes, provide enterprise class, secure access, and deliver on digital business expectations through a modern, intuitive user experience.

    Document Management Use Cases

    1. Training, Onboarding, and Job Aid Content

      Managing the documents associated with training, onboarding and continuous learning typically reside in shared folders, email and document files. But it lacks version control and is difficult to deploy and update. A proper document control solution simplifies the entire process, creating new efficiencies, agility and employee engagement and compliance.

    2. Contracts & Legal Documents

      As businesses continue to evolve, partnerships are playing a more critical role than ever. From initial negotiations to qualifying to contracting and ensuring ongoing performance, managing all of the associated documents and data is critical to keep all parties aligned. Secure, real-time access also helps minimize unnecessary risks and administration.

    3. Acquisition & Divestiture Clean Room

      Mergers, acquisitions, and divestitures require "clean rooms" for business partners to consolidate, share, and control content and data necessary to complete deals while staying fully compliant with antitrust regulations, such as from the Hart-Scott-Rodino Act of 1976. With secure, controlled access available in real time, team members can maximize time for due diligence to ensure the real value of synergies, proper valuations, and a clear understanding of risks and issues while ensuring sensitive or competitive data is always secure.

    4. Claims Substantiation

      Claims are supported by substantiation documentation generated from consumer studies, clinical trials, and other scientific publications. These documents provide the evidence to support the creation and use of the claim from the start and to protect the organization from legal challenges from competitors, consumer groups, or regulatory bodies. Effectively managing the substantiation documents, relationships to claims, and other supporting content ensures if issues arise all of the information is immediately available, accurate, and up to date.

    5. Quality Documents - Manuals, SOPs, Specifications

      An efficient document control process is an essential part of compliance requirements in regulated industries subject to GxP and ISO standards. Employees and partners need the ability to author, collaboratively review, approve, and release documents such as SOPs, Specifications, etc.). This includes users being able to easily and securely access the most current version of any document, automatically collect audit trail information, and leverage real-time collaborative authoring to reduce review cycles and implement changes faster. 

    6. Regulatory Documents

      Regulatory Affairs teams need the ability to plan, collect, review and approve all product-related content for regulatory submissions. This includes submission-ready documents, content planning and tracking, correspondence, product claims commitments and submission records. These submissions capabilities must provide full traceability for all regulatory activities.

    7. Other Use Cases
      • Human Resources Content & Policies
      • Marketing and Sales Collateral
      • Project Management Deliverables
      • SOX Compliance

    Capabilities of a Document Management System

    Though specific programs may differ, document management systems universally serve certain purposes and have similar capabilities:

    1. Centralized document storage: A modern document management system eliminates the need to jump between shared files, critical data, and document storage. With everything housed in one place, tasks can be completed with full access to all necessary elements in one dashboard. 

    2. Compliance and control: Your proprietary information and data is crucial to your business' success. A document management system allows you the flexibility to manage access, secure information, and ensure consistency. 

    3. Collaborative files: With your documents gathered and secured in one location, the ability to collaborate is critical to any document control system. A secure, cloud-based system will allow your team to save time, collaborate effectively, and ensure everyone is on the same page. 

    4. Robust Audit Trail: It is necessary for your audit trails to capture every event in a process, including 21 CFR Part 11 compliant signature execution, task creation and assignment, and more. A well-implemented document control system makes it easier to alert stakeholders to issues, provide faster audit documentation and fix any issues that may arise. 

    Ready to explore how Veeva can help you transform your organization? 

    Try Veeva Watch Demo Read Doc Control Product Brief