This posting is Part Two of a two part series discussing the implementation of Scan, Declare, Destroy processes in a legally defensible and compliant manner. Part one provided the background and introduction to a framework developed by the Document and Records Management Special Area Interest Community (SAIC) of the Drug Information Association (DIA). In Part Two the framework parameters are presented in slightly more detail and considerations for implementation are provided to facilitate the right discussions in your organization.
Legal and Information Governance and Compliance Opens the Doors
The review of glossaries and policies should start in Legal and Records Management or Information Governance and Compliance. Research by the DIA team determined that so long as the electronic record was used in “every day” or Business As Usual (BAU) business processes to make corporate decisions, the electronic version would stand on equal footing from a legal perspective, including but not limited to patent and IP protection and eDiscovery. Companies must be vigilant here and make sure consistent language is used from Records Management frameworks to legal hold policies and processes through to clinical processes.
Essentially, records management policies need to be consistently applied to third parties acting on behalf of, or carrying out activities in support of the organization so a review of clinical policies and how contracts are implemented is required. GxP Predicate Rule interpretation supports these parameters and therefore reinforces the importance of overall process and policy governance to open the door to building out compliant and legally defensible paper destruction processes.
Destruction of paper record versions may take place so long as there are no records management policies or retention schedule requirements prohibiting such a process and so long as the electronic version is deemed accurate and reliable. The records management policies must then also cover the management of these records and treatment of copies from cradle to grave through the records lifecycle. This lifecycle includes creation, use, preservation and archiving and final disposition and destruction.
Functional Electronic Content Management System (ECMS) or electronic Trial Master File System (eTMF) Will Be Needed
A company will need to store the images and will probably want to store an index and record metadata in a way that improves searching and retrieval, knowledge sharing and that supports externalization efforts. While smaller organizations may be able to use validated processes that support collaborative spaces, network file shares, eRooms and SharePoint sites to manage the scanned images and metadata, larger organizations will want to have a fully validated system in place to handle the content, metadata, audit trail information and so forth. Many companies are considering, have recently built or are in the planning stages of building an eTMF and planning for a future scan-declare-destroy process should happen during the development of such a system if possible.
You’ll Also Need to Consider Broader "Technology" Requirements
Minimum requirements and best practices exist for scanner settings, ECMS/ eTMF systems and the format(s) for document preservation and each company will want to be sure that their technology supports or exceeds these requirements. Most companies have technology in place that meet the technical requirements but the center of excellence may not be in the clinical group so you may need to look to finance or other groups that have typically carried out high volume scanning and production activities.
The Framework for Paper Destruction provides these key considerations and expands into other parameters including leveraging optical character recognition and ensuring strong change management programs exist to help an organization’s successful implementation. Each parameter in the framework is supported by key references in a manner that will support building that maturity and confidence in your stakeholder group.
Regulatory and Quality play key roles in the framework and must not be forgotten
The framework is not just about technology validation, policies and glossary updates so don’t forget that you are building processes around regulated activities and therefore must include your organization’s quality and regulatory compliance groups at all levels. Regulatory and quality must weigh in on the use, intent and verification of signatures, the validation of computer systems managing regulated electronic records and lastly authenticity and preservation requirements as described in greater detail by the Framework for the Destruction of Paper in these topics as well as Legal and Records Management. More specifically, each organization will need to determine level of quality to build into their processes and how they will define the terms “complete” and “accurate” in terms of electronic scans of paper records and declaring these scans the official business record.
The Framework for the Destruction of Paper is a great step towards Scan, Declare, Destroy and specifically does a great job of providing teams parameters to consider and key references in support of the guidance provided, particularly with respect to implementation as tackled in this second part of the two part series. The implementation of a Scan, Declare, Destroy starts with a mature Information Governance and Compliance foundation. Once the doors are opened though, the process is complicated; it includes a number of key stakeholders in an organization; it requires a knowledge and understanding of many pharmaceutical functional processes as well as a culture that understands that business process and requirements should drive technology selection. Don’t take this journey alone. Instead choose a partner that knows the process, the technology, records management fundamentals and the clinical landscape to walk with you. Take a first step by reviewing and providing feedback on the Framework for the Destruction of Paper and then see how that framework can become your new reality.
What do you think about the DIA DRM SAIC’s Framework for the Destruction of Paper?