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. Share via: Twitter LinkedIn Facebook Email
EVENT 9th GCC Regulatory Affairs Pharma Summit (and Quality Conference) 2024 GCC Regulatory Affairs Pharma Summit is an annual event that provides platform for pharmaceutical regulatory experts and industry professionals in the GCC region to share insights and discuss about the latest updates in the pharmaceutical regulations. We are Gold Sponsors of the 9th GCC Regulatory Affairs Pharma Summit 2024. Learn more
EVENT Honeywell Life Sciences Innovation Days Honeywell invites you to join us for one of our Life Sciences Innovation Days, a series offered throughout the globe in 2024. We will present a variety of process innovations to support the digital transformation of life sciences manufacturing. Themes will include orchestrating systems and data, preventing and containing cyber incidents, quality control and management, modular automation, and the Honeywell life sciences roadmap. Discussion will address streamlining manufacturing, creating batch records, and fulfilling regulatory reporting requirements. Learn more
EVENT Pharma Manufacturing World Summit Join us at Pharma Manufacturing World Summit on May 14, 2024 where Honeywell's Zillery Fortner will be co-presenting on "The Value of a Unified Life Sciences Solution in Pharma 4.0." Learn more
EVENT TUG Europe Join industry peers at one of these FREE events for TrackWise and TrackWise Digital customers, with two dates and locations to choose from. Enjoy a networking at our pre-event receptions, as we celebrate 30 years of TrackWise! Take advantage of a FREE TrackWise Digital pre-event training workshop. Learn more
EVENT RQA 2024: International QA Conference With diverse industry representation including regulatory authorities like the MHRA, it’s a hotspot for those in GCP, GLP, GMP, pharmacovigilance, and more. The conference has evolved to cover a wider scope, offering unparalleled networking opportunities across three dynamic days for delegates, sponsors, and exhibitors to engage on pivotal industry topics. Register to attend this insightful event where you can hear our Industry Business Development Director, Fabrizio Mangilio deliver one of this year's RQA 2024 keynote sessions. We are Platinum Sponsors of the RQA 2024: International QA Conference Learn more
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