Document Management Systems: Risks and Solutions January 16, 2023 Document management is the process of creating, storing and controlling documents that are related to the quality of the products being manufactured. Examples of these documents include quality manuals, procedures, work instructions and records of inspections, audits, and test results. Risks of Poor Document Management Proper document management is essential for ensuring the quality of products and maintaining compliance with industry standards and regulations. Poor document management can lead to a number of risks, including: Noncompliance with industry standards and regulations, which can result in fines, penalties or loss of certifications Inaccurate or incomplete information in documents, resulting in errors in manufacturing processes and resulting in poor quality products Difficulty in finding and accessing necessary documents, leading to delays and inefficiencies in the manufacturing process Inability to track and trace changes to documents, which can make it difficult to determine the cause of quality issues Document Management Best Practices There are a number of best practices and tools that can be used to manage documents effectively, including: Establishing a document control system that defines how documents are created, reviewed, approved and stored Implementing version control to keep track of changes to documents over time Ensuring that documents are easily accessible to those who need them Regularly reviewing and updating documents to ensure they remain accurate and current Conducting audits and inspections to ensure that the document management system is working effectively How Can Technology Aid Proper Document Management? A quality manager looking for a document management solution for their company would likely be looking for technology features such as: Document version control: This allows for tracking and managing different versions of a document, so that the most current version is always being used. Document approval workflow: This allows for a defined process for creating, reviewing and approving documents, ensuring that all documents are accurate and up-to-date. Access control: This allows for controlling who can access, view and edit different documents, ensuring that only authorized personnel have access to sensitive information. Document searching and retrieval: This allows for quickly finding and retrieving specific documents, making it easy for employees to access the information they need. Audit trails: This allows for tracking changes to documents over time, making it easy to determine who made changes and when. Electronic signature capabilities: This allows for documents to be signed electronically, making it easier to ensure that all necessary approvals are obtained. Integration with other systems: This allows for the documents to be integrated with other systems, such as quality management software, enterprise resource planning (ERP) systems and manufacturing execution systems (MES). Mobile access: This allows for access to the documents from mobile devices, making it easy for employees to access documents while working on the factory floor or in the field. Cloud-based or on-premises: This allows for the choice of hosting the document management system in the cloud or on the company’s own servers. Security: This ensures that the documents are stored and transmitted securely, protecting sensitive information from unauthorized access. WATCH MORE ABOUT DMS Resources About Document Management Solutions: WHITE PAPER: An Integrated Approach to Quality – How to Tighten the Connection between Quality Management and Document Management. DATASHEET: TrackWise Digital Document Management – Manage Quality Documents from Anywhere. LEARNING: Course: TrackWise Digital Document Management System – This eLearning OnDemand course is for those new to the TrackWise Digital Document Management System (DMS) application. The course provides an overview of DMS as a document management tool. REFERENCE: TrackWise Digital Document Control Software – TrackWise Digital document control software keeps all your documents in a single, centralized location, helping you combine quality processes and more easily achieve regulatory compliance.
BLOG Accelerating Time-to-Market in Life Sciences Manufacturing Speed matters in life sciences manufacturing. Competitive pressure, complex product portfolios and evolving regulatory expectations all place increased emphasis on faster, more reliable delivery of new and existing therapies. Learn more
BLOG From Data to Knowledge: Building Workforce Intelligence in Pharma Manufacturing Pharmaceutical manufacturing generates vast amounts of data. Process values, batch execution details and event histories are captured every day. Yet data alone does not drive improvement. Learn more
EBOOK Optimizing Pharma Manufacturing: An Executive Guide to Overall Equipment Effectiveness (OEE) Pharmaceutical manufacturing has never been more complex. The shift toward biologics, personalized therapies, and multi-product facilities demands precision, agility, and rigorous documentation. Yet, many manufacturing leaders still struggle to answer a basic question with confidence: How effectively are our assets actually performing? Learn more
BROCHURE TrackWise® Manufacturing Digital Procedures TrackWise Manufacturing Digital Procedures delivers advanced functionality specifically designed for recipe-based work instructions that demand sophisticated logic and decision-making capabilities. Learn more
WEBINAR Alert to Action: How Connected Digital Execution Turns Pharma Data Into Decisions In this session, Honeywell Life Sciences expert Zillery Fortner and Arshad Azwad explore how digitally connected execution ecosystems move manufacturers from reactive response to proactive control, enabling faster decisions, fewer errors, and inspection-ready operations by design. Learn more
BROCHURE TrackWise® Manufacturing Electronic Logbooks TrackWise Manufacturing eLogbooks deliver a fully integrated electronic logbook solution designed specifically for GxP manufacturing environments. As a module within the TrackWise Manufacturing operations management platform, the solution digitizes and streamlines equipment logs and procedural records while supporting regulatory compliance. Learn more
BLOG Reducing Total Cost of Ownership with an Integrated Pharma Manufacturing Platform Reducing TCO is not only about software licensing. It’s about minimizing complexity across the full lifecycle of manufacturing operations. Learn more
BLOG How to Choose the Right MES or Manufacturing Operations Platform Selecting an MES or manufacturing operations platform is a strategic decision with long term implications. In pharmaceutical and biotech manufacturing, the platform chosen influences compliance, scalability, data visibility and the ability to continuously improve operations. Learn more
BLOG Improving Manufacturing Performance – Moving Beyond OEE to Operational Intelligence Overall Equipment Effectiveness (OEE) is widely used in pharmaceutical manufacturing to assess equipment availability, performance and quality. But in complex, regulated environments, improving performance requires more than retrospective metrics. It requires operational intelligence: Learn more
BLOG What is MES in Pharma Manufacturing? A Practical Guide Pharmaceutical and biotech manufacturers are operating in increasingly complex environments. Manufacturing Execution Systems (MES) have become essential infrastructure in this context. Learn more
BROCHURE TrackWise® Digital QuickTrack TrackWise Digital QuickTrack delivers the power of enterprise QMS without the complexity or cost—getting you compliant and operational faster. A streamlined solution and delivery approach designed specifically for startups, small, and medium-sized businesses. Learn more
BLOG Rethinking Life Sciences Quality & Manufacturing Operations in the Age of AI And Connected Systems Quality decisions in life sciences rarely fail because people don’t care. They fail when signals arrive too late, in the wrong place, or without enough context to act confidently. By the time an issue becomes a deviation, an investigation or even a recall, the early warning signs were usually there – they just weren’t connected, visible or actionable. Learn more
CASE STUDY Insud Pharma’s Journey with TrackWise Digital: Transforming Global Quality Management Insud Pharma shares how it transformed its global quality operations using TrackWise Digital QMS to standardize quality, document, and training management across manufacturing sites worldwide. Learn more
BROCHURE TrackWise® Manufacturing Operations Management Platform Transform Your Manufacturing Operations With Unified Digital Manufacturing Intelligence Learn more
BROCHURE TrackWise Manufacturing: Overall Equipment Effectiveness (OEE) Maximize Production Performance and Regulatory Compliance: With Real-Time OEE Monitoring & Analytics Learn more