Many industries have successfully implemented processes whereby paper business records are scanned, the electronic version declared the official record, and then the original paper version destroyed. This posting is part one of a two part series that describes how a large group of pharmaceutical industry professionals developed a framework that may be applied to individual organizations as a first step in implementing this type of process in a legally defensible and compliant way. Don’t call in your destruction vendor until you understand the various parameters that need consideration and define how your organization will mitigate the key risks.
Examples of Scan – Declare – Destroy processes are generally found in high volume workflows where the scanning solution provides significant process efficiencies in the automated capture, indexing and storage of metadata that is then leveraged for improved search and retrieval processes. The regulated pharmaceutical industry has for a long time been looking to implement similar processes, particularly in the area of clinical records management where adopting such a process is seen as the holy grail for managing clinical studies that need to be shared across business units, global sites and Clinical or Contract Research Organizations (CROs).
With the adoption of a Trial Master File Reference Model published through the Drug Information Association (DIA) Document and Records Management Special Interest Area Community (SIAC), the industry took a first step toward harmonizing the classification and indexing of trial master file records. Now the industry has taken yet another step in the publishing, again through the DIA Document and Records Management SIAC, the Framework for the Destruction of Paper. Is Scan – Declare – Destroy the new reality?; here are the key items you need to know before you call in the shredders.
The framework is still a draft and in need of broad industry and regulatory feedback and endorsement
The published framework is still a work in progress that was compiled by over 40 industry professionals from 25 pharmaceutical organizations, CROs and consulting firms. While the contributions were from such a large network of professionals, it still needs to be fully vetted by the organizations and more importantly by the various regulatory agencies that audit drug trials across the globe. The framework does not stipulate a specific technology, required quality policy or specific records management procedures; rather it presents key considerations called parameters across multiple topics in a manner that stimulates discussion and provides a strong platform on which to build a sound process for paper destruction. This is a chance for all of us in the industry to become involved and make scan – declare - destroy the new reality.
The scope of the framework is limited to North America (NA), the European Union and Japan
It is also important to note that the scope of the DIA SIAC team’s effort was purposefully limited to NA, Europe and Japan. While most of the largest pharmaceutical companies operate out of, support research and conduct clinical trials in these regions, the framework will likely need to be expanded to include many of the countries and regions where clinical studies are being performed or where drugs are now being marketed. Old Soviet block countries, South America and other Asian countries may all need to be considered in future versions of the framework as the regulatory and records management requirements may be considerably different in these countries from those of this initial release.
Implementation may require significant organizational changes
Scan – Declare – Destroy sounds quite simple but in reality the change requires a number of key stakeholders within an organization be involved, including Legal, Quality, Records Management, IS and of course Clinical, to assess the current state of their governance framework, e.g. policies and procedures, and to agree what changes can be made to begin opening the doors to this new set of processes. Many of these changes will require a review of corporate glossaries and terminology, records management policies and retention schedules, legal hold requirements and the like.
Getting these stakeholders to participate is often challenging in its own right and many of my clients continue to struggle with getting these individuals together because it requires stakeholders that have knowledge and understanding of a diverse set of processes. Once this group is compiled, it must mature its thinking and become educated in the key topic areas the framework addresses.
Part One of this series demonstrates a number of key points that should keep your shredders at bay. First, you can’t “just do it”. In a landscape of eDiscovery and litigation fears, regulatory audits and findings and the new challenges of social media and electronic devices, Corporate Information Governance and Compliance groups must be consulted to ensure that enterprise records management policies and procedures have been positioned appropriately to support these efforts.
Second, it’s a global economy and the rules aren’t always the same in one region to another, let alone from one country to another. Tackling Scan-Declare-Destroy is going to take key leaders in your organization to not only support, but to contribute to the requirements that will make the framework a success in your organization. Lastly Part One illustrates that, in order to get this level of engagement, your organization may need to grow in a records management, quality, technology and/or legal maturity perspective. Investing time in learning this framework from Pharmaceutical professionals is a good first step.
Part Two will then show you how to open the doors to Scan – Declare – Destroy in your organization using the framework developed by the Document and Records Management SAIC of the DIA. It will help you understand the framework and its parameters in a way that will help your organization avoid many of the common pitfalls and clear a path for a legally defensible and compliant implementation.