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eTMF Guide


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  • 1. Freyr Electronic Trial Master File: The Guide This paper gives you an insight on: >> Understanding the concept of eTMF >> Realizing requirement and readiness >> Steps involved in implementation >> Advantages of using eTMF over Paper-based TMF ©2013 Freyr Inc. All Rights Reserved.
  • 2. Overview Regulatory authorities worldwide have emphasized on the need to adopt eTMF Systems for greater flexibility, security and control over the control of large volumes of documents. In the present day there is an immense requirement for a safe, secure, productive and efficient system of document management in the Life Sciences industry. The management of numerous documents, literally in the thousands in paper-based formats is neither easily manageable nor provides the flexibility needed for effective collaboration and control. This present method is time-consuming and resource hungry and companies have begun to understand the need and importance of newer and more efficient system, which is the Electronic Trial Master File (eTMF) System. Why leave system? the paper based While the conventional system has served companies well in the past, it was more of a matter of acceptance and reliance rather than being a matter of approval. Technology in the past was not as accessible and affordable as it is today, and the present day offers highly effective technological solutions that can transform this work-flow into one that is more advanced, safer, more secure, affordable, productive and highly efficient. Some of the prominent challenges that companies face when they use the paper based systems are outlined below:  Inconsistency in standards: The standards like naming conventions for files and folders, document classification, etc. varied from company to company. This creates discrepancies in standards and poses difficulties in standardization and during submissions.  Managing huge data: Paper is physical. It requires space, storage, transportation, is delicate and degradable, difficult to back up, hard to collaborate on, poses difficulties in correction, uses more financial capital, and poses a threat to the ©2013 Freyr Inc. All Rights Reserved. environment. The increase in the number of companies and the clinical trials they work on has posed difficulties to both companies and Regulatory Authorities, with paper TMFs posing difficult challenges in documentation and management.  Time and Accuracy: It is difficult to search for information on paper. This difficulty is exponentially increased when dealing with multiple documents. Accuracy is another affected factor. Necessary revisions on documents need to be tracked and maintained in audit trails. In paper based system, it is difficult to track the same and accuracy is compromised most of the times.  Transparency: With paper-based systems it is difficult for document users to check document status and see document position in their respective work flow. Unless documented at each granular point, which is again a very difficult task in itself, and is not accessible to everyone simultaneously, this task, which is manual or semi manual in nature is very difficult to execute effectively. Business Rationale in Moving to the Electronic Document Management System Technology provides efficiency, productivity, security and stability. In addition, technology allows collaboration in standardized formats across multiple geographical locations instantaneously, once again, offering huge savings in costs and valuable resources. Users now expect flexibility and speed with easier means of control and access. And this is effectively delivered through technological solutions introduced into the work flow, mainly the Electronic Trial Master File (eTMF) Systems. While Paper based systems can serve as parallel backups to the electronic system, companies are trying to find alternative to the same as they understand the ease of using the electronic
  • 3. method. In the near future the DMS is definitely the primary source of storing and managing files and folders. Few of the business rationale for moving from paper-based system to DMS are outlined below: Reduction in time: Reduced time in document access and control, audits, file requests, collaboration, file searches and submissions.  Business Confidence: Electronic DMS systems provide the confidence that you have met the relevant compliance requirements and business standards  Improved Document Quality: Automated systems increase the document quality to a greater extent and result in minimization of the errors which would have resulted otherwise if there were manual processes  Enhanced Productivity and Transparency: Managing, sharing, and viewing documents  becomes extremely transparent and the entire process is easily controllable. All the more the entire process is way faster than the manual process. Advanced search and filtering features further add to productivity and efficiency. It also increases the organization's work flow responsiveness and readiness.  Reduced Costs: Automated process helps in reducing the auditing and reporting costs. Also it helps in the reduction of the labor and travel costs  Savings in Resources: The eTMF System increases the quality of internal and external collaboration by reducing time, money and resources spent on file control, organization, review, approval, publishing and archiving, storage, logistics and supplies. Freyr eTMF Value Proposition            Reduced document management and storage costs Improved business standards Quick response to queries Integration of the data into prevailing systems Immediate access to data Transparent process Increased productivity and accountability Reduce direct and indirect costs Speed up the time to market for new drugs Improve quality and compliance of documentation Strengthen communication ©2013 Freyr Inc. All Rights Reserved.
  • 4. REAL TIME SCENARIOS PROBLEM: Transfer of Legacy Documents after in-licensing a certain Phase-2 drug Scenario 1 CONTEXT: Consider a certain Phase-2 drug in testing that was inlicensed in a different clinical indication. The transfer of documents revealed a large number of legacy documents prior to licensing. This client preferred the eTMF solution on account of Cost Reduction, cloud hosting option, easy installation and immediate deployment. SOLUTION: The eTMF Solution provided allowed customization to support management of the aforementioned legacy documents as well as existing clinical trial files. They hosting model appealing and our interface user-friendly and simple in design. The Metadata configuration options added further advantage in allocation of files, and further functionality provided by Advanced Search capabilities and filtering options improved process efficiency and productivity. The System allowed them to manage documents ranging from Clinical Study Documents, SOPs, Legacy Reports, Manufacturing Documents and Work Instructions. Training was provided to the client. VALUE: Savings in time and effort with regards to locating Legacy Documents, seamless and fluid collaboration capabilities within the core internal team, decreased time and resources. All related documentation was collected, collated and uploaded into the System and made available online, allowing easy access, updates and monitoring. Furthermore, training was conducted to acquaint end users with the system, significantly reducing starting time. Email notifications allowed further control to core team members for monitoring the work flow. ©2013 Freyr Inc. All Rights Reserved.
  • 5. PROBLEM: FDA 21 CFR Part 11 Compliance, Customizations, SharePoint compatibility Scenario 2 CONTEXT: Customizations are often difficult to maintain and require high investments. Our solution is compatible with all major existing Microsoft-compatible formats, providing a cost-effective solution to the client with minimal maintenance costs. The system provides an intuitive environment for managing documents and ensuring compliance in Regulatory Submissions. Seamless collaboration capabilities are optimized for a smooth work flow enabling all core team members to work while maintaining a unified view of the workflow including the status of all involved documents like Clinical Study Documents, SOPs, Legacy Reports, Manufacturing Documents, Legal Documents, Process/Product Specifications and Work Instructions. A key part of regulatory compliance is the adherence to Title 21 of the Code of Federal Regulations - Part 11, which contains required information for the management of SOPs and other documents. Impressed with our product's functionality, features and easy to use interface, affordability, reliability, and regulatory compliance were the biggest drivers in making the decision of selecting our product. SOLUTION: Our Solution is specifically designed for the full management of Standard Operating Procedures (SOPs) and other critical documents, offering a fully compliant FDA 21 CFR Part 11 document management solution, compatible with Microsoft SharePoint. Our solution offers an ideally affordable, secure and easy to use solution for regulatory document management needs. VALUE: Our solution offers the following benefits and value to clients FDA 21 CFR Part 11 Compliance • FDA-Audit Proven • Microsoft SharePoint Compatibility • High Returns on Investments and affordability • Implementation and deployment within a week • Effective training in 40 working hours • 100% Success in Submission Quality and Quantity• On-site or Cloud-based Hosted Models • Easy to Use ©2013 Freyr Inc. All Rights Reserved.
  • 6. PROBLEM: Conversion from paper to electronic format Scenario 3 CONTEXT: Consider a company dealing in products with a focus on high quality and affordable costing, and a mission to cater to clients worldwide. Such a company would appreciate economies of scale and reductions in costs wherever possible. Such a company must ensure success in Regulatory Submissions to effectively release its products into the world market, and this is done through effective document management systems in place. Such systems allow compliance and adherence to standards set by Regulatory Agencies, reduce time involved in documentation, review and submission cycles and support faster approval times. SOLUTION: The following steps were taken to implement the eTMF System: 1) Prerequisite installation checks where End Users and the IT Team on client end were engaged in telecommunications, software and hardware details were collected and collated for the planned installation. 2) In this case the client opted for the Cloud-based model, so no on-site installation was necessary. 3) Comprehensive Training was provided to the End Users and IT Team at Client End. VALUE: Currently, the client is managing all their DMF and ANDA / eCTD submissions to the US FDA using our Electronic Trial Master File (eTMF) Solution which has given the following advantage: Effective compliance in submissions without delays and hindrances, higher quality of submissions, savings in valuable resources and time, easier compilation and documentation, as well as easier reviews and audits. Conclusion All the stakeholders in the life sciences domain need to have both online and offline access and control over the process and the eTMF documents to speed up the entire process and all the more adhere it to the standards for review, compliance and audit, and quality control. Additionally, as we see that things are changing with extreme pace companies need to keep pace with as well and thus need to adopt easier and faster methods for their processes, one of which is the adoption of the eTMF. Many organizations have started to migrate to electronic document management solutions and have seen immense benefits, ROI, and productivity ratios. Freyr provides this service via its eTMF solution. This system is equipped to handle all the issues and challenges which existed in the paper based system. To schedule a free consultation please write to ©2013 Freyr Inc. All Rights Reserved.
  • 7. Contact: Kalyan Palle Business Alliances Manager Nilofar Nigar Marketing Manager ©2013 Freyr Inc. All Rights Reserved.