Three reasons to take your Document Management digital November 27, 2019 How does your organization manage important documents like policies and specifications? If you thought of a person or envisioned a gigantic three-ring binder, it’s time to upgrade your document management approach. Smart manufacturing processes and sophisticated supply chains need to be backed-up by intelligent document solutions. Digital document solutions reduce some of the stress associated with FDA inspections and ISO audits and position your company for growth. As you add locations or product lines, it’s easier to keep the company aligned digitally. Digital solutions offer three distinct advantages over paper-based processes: compliance, control and collaboration. Compliance Document management tools automate some of the safeguards required by the FDA and EU regulators, such as provisions for signatures. Electronic signatures become clearly linked to a single document and document stage (such as review or approval). Business rules can be enforced to make sure the guarantor has the right authority to sign-off. And with a single repository, staff from anywhere in the business can quickly and confidently access the right version of a policy, procedure or training document. In contrast, paper files are prone to mistakes. Even simple errors – like illegible handwriting or an incorrect date – could put operations at risk. When an auditor shows up, staff could grab the wrong file from a cabinet, or the correct document could be stuck on someone’s desktop. Control Paper files are difficult to protect. In print, proprietary information can be copied, misplaced or shared inappropriately (intentionally or not). With digital solutions, companies gain greater control over their information. With electronic systems, printing and downloading can be restricted. Document rules can be configured to match your business and compliance practices – and then enforced automatically, without the risks associated with human error or judgement. Dozens of departments and people are affected by every document. Collecting input and disseminating final documents – correctly and efficiently – is difficult to manage via email or folder-based sharing systems. And, the risk is too high that someone will reach for an outdated version during an inspection. Companies need a single repository for documents, clearly identified as “final” or by their current status. Collaboration Each document impacts a large number of people and processes, so a lot of stakeholders need to provide input before a document becomes final. Managing reviews can be a nightmare via email or a folder-based sharing system. Digital document management systems house all of the changes and comments submitted by stakeholders, so their input is documented and shared with the entire team. And multiple reviewers can work on a document at the same time, eliminating version-control issues and endless cycles of review. Most digital solutions also include search features or ways to link files, so it’s simple to find related documents (like training plans) that are affected by changes in process. With digital document management solutions, a file’s status is clear, as are the next steps. Everyone stays on the same page and understands their role in the process. Automatic Advantages What’s more, the benefits of digital document management can be automated. Once you set up a workflow, a digital document management system can automate the next steps. Stakeholders will automatically be triggered when they need to act, when a document is nearing expiration or there’s a change to a standard operating procedure. Some document management systems integrate with quality management activities such as corrective and preventive actions. When document workflows are standardized and automated, you don’t have to fear discrepancies in documentation across the organization. You’ll have one less thing to worry about. 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
WEBINAR Using Batch Historian Technology to Accelerate Data-Driven Manufacturing Optimization Join our webinar to explore how Batch Historian technology can streamline data capture and reporting, enabling faster, informed decision-making. Register Now! Learn more
WEBINAR Revolutionizing Life Science Recalls Explore how the latest innovations in data fabric technology can revolutionize product recall management, ensuring future-ready, agile and effective recall processes. Learn more
EVENT 7th Annual European Medical Device & Diagnostic Quality Assurance and Regulatory Affairs Conference Unlock tomorrow's standards today: Innovate, collaborate, and lead at the Quality Assurance and Regulatory Affairs Conference! The 7th Annual European Medical Device and Diagnostic Supplier Quality Management Conference aims to bring together the industry’s top-performing Supplier Quality Management (SQM) & QA QC professionals under one roof. Distinguished speakers will discuss cutting-edge strategies and procedures for meeting regulatory SQM & QMS requirements, implementing risk-based approaches, minimizing the risk of quality failures, and linking QA QC processes throughout the product life cycle. This two-day in-person conference will provide attendees with live content and highly interactive sessions supported by real-life business examples, case studies, Q&A sessions, panel debates, and interactive workshops. You’ll be able to network with your peers, including leading technology innovators and service providers, while exchanging ideas with the experts in a collaborative setting. We are Bronze Sponsors of the 2024 Medical Device QA & SQM Conference in Belgium. Learn more
WEBINAR Discover How Gedeon Richter Transformed Their Quality Management Hear how leading European Pharmaceutical and Biotech company Gedeon Richter successfully implemented a digital quality management system to support their business goals and patient-centric mission. Learn more
WEBINAR AI-Driven Innovation: Redefining Quality Management in Life Sciences Take a deep dive into the confluence of AI and life sciences, exploring how artificial intelligence is poised to revolutionize the realm of quality management in the sector. 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
EBOOK 5 Things to Know About EUDAMED EUDAMED (European database for medical devices) is a centralized database that aims to enhance the transparency and traceability of medical devices in the EU. Learn more
WEBINAR EUDAMED 2024 and Beyond: Preparing for the Future of Medical Device Oversight Watch our on-demand webinar and gain valuable insights into the transformative impact of EUDAMED on the Medical Device industry. Learn more
WHITE PAPER Future-Proofing a Pharma Manufacturing Legacy through Digital Quality Transformation As industries adopt technological advances and rapidly move into the fourth industrial revolution, it is essential to assess the impact of these isolated data pockets on the workforce, customers and the safety of patients. Learn more
WHITE PAPER Bridging the Gap: Integrating Quality and Document Management When quality and document management systems are integrated, life sciences companies can maximize the value of each platform and create a “total quality” environment. Learn more
WHITE PAPER Harnessing Quality Management Innovation in Life Sciences Discover the Power of Quality, Data, and Patient-Centricity in Life Sciences through Exclusive Whitepapers with CIO.com and Salesforce Learn more
WEBINAR Transforming Quality Operations in the Digital Age Learn how Orion is using TrackWise Digital® to transform quality operations and enhance traceability among suppliers to continuously improve quality and patient safety. Learn more