Document Management: Communication with Regulators January 18, 2023 Document management technology can be used by manufacturers in regulated industries, such as Life Sciences, to aid their communication with regulators in several ways. Compliance: The use of document management technology can help manufacturers in regulated industries meet regulatory compliance by automating the document management process, making it easy to create, review, approve and store documents. This can help to reduce the risk of errors in the manufacturing process and ensure that all necessary documents are readily available for review by regulators. Electronic submission: Many regulators, such as the FDA, now accept electronic submission of documents. Document management technology can help manufacturers prepare and submit these documents electronically, making it easier to submit the documents in a timely manner. Auditing and tracking: Document management technology can also help manufacturers to track and audit the changes made to a document. This can be useful during a regulatory review as it allows manufacturers to demonstrate that documents have been reviewed and approved by the appropriate personnel and that any changes made have been properly documented. Secure storage: In regulated industries like pharmaceuticals and medical devices, manufacturers need to ensure that sensitive information is stored securely. Document management technology can help manufacturers to store documents securely, protecting sensitive information from unauthorized access. Reporting: Document management technology can also help manufacturers to generate reports that can be shared with regulators. Reports can include information on the approval status of documents, changes made to documents and compliance with regulations. Overall, document management technology can help manufacturers in regulated industries manage and control their documents more effectively, making it easier to comply with regulations and demonstrate compliance to regulators during inspections and audits. 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.
EBOOK Life Sciences Industry Insider: Product Quality Ever wonder how TrackWise can help IT leaders in Life Sciences drive greater operational efficiency? Learn More. Learn more
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EVENT 2024 ISPE Pharma 4.0™ and Annex 1 Conference We're at ISPE Italy! Visit our booth to discover how we can help you accelerate your digital transformation journey. Learn more
EVENT BMWS Bio Manufacturing World Summit 2024 Join us at the Biomanufacturing World Summit to discover how our advanced life sciences manufacturing solutions can help enhance operational efficiency. Learn more