The FDA and other global regulatory agencies began accepting electronic files for at least parts of submissions for testing and marketing drugs in the early 1990's. This has culminated in the creation of the Common Technical Document (eCTD) standard which now is required in the US and most countries around the world. Paper records were traditionally stored in a central protected environment managed by a defined set of managers. Electronic records reside within a multitude of locations. Some managed by a central authority, but most are under the control of individuals. These individuals possess a wide scope of computer based devices which can be used to author, store, copy and transmit relevant information; i.e. phones, laptops, tablets, USB storage devices. In addition, this information can be stored and shared within a wide variety of locations on the web. Some better protected than others.
The process of verifying the authenticity of a record has changed substantially. Paper records were authenticated via inked signatures of the author and witness. This practice has been dwindling being replaced by encrypted e-signatures. Many organizations have a large collection of paper records with retention times of 50 years or more. There is a dilemma of how to best preserve and utilize these records.
All repositories of information, whether paper or electronic are best managed by first establishing a Records and Information policy that includes all information types and their locations within an organization and perhaps other organizations. It has become increasingly evident that electronic information cannot be effectively managed using the traditional protocols and procedures. Some organizations had hundreds (even thousands) of retention schedules for their paper records. This does not work well for distributed electronic records. The trend has been to create larger retention buckets to characterize records that have some similarity of at least the same retention time. However, many of the protocols for paper can be applied to e-records. For example having some kind of map that shows where all categories of information reside in an enterprise is invaluable.
There is a dilemma to be faced when the majority of records are electronic, but a substantial number remain as aging paper records. Should all or some paper records be converted to an electronic format or it it better to leave them in their current form? The cost of complete conversation and subsequent integration could be very expensive, especially is the paper records are rarely referenced. A better approach is to convert on an as needed basis. This can be integration into an eCTD or if the documents are being referenced more frequently.
Why Should You Attend? The Electronic Common Technical Document (eCTD) has been the standard, accepted electronic format for NDA, ANDA, IND, BLA, DMF and BMF submissions to the FDA since 2008. The introduction of legacy paper records into an eCTD is accomplished via scanning onto a text readable format. However, there are vast stores of pre-clinical, clinical and drug safety paper records that are archived by many companies for drugs that failed to reach the marketing stage for a variety of reasons. This archived data could support submissions for other new or emerging indications for the drug or support efficacy or safety for related drugs.
Areas Covered in the Session:
Records policy and procedures
Records data map
Incorporating paper records into a eCTD
Converting paper documents into a useful electronic format
Scanning costs and resources
Indexing and organizing scanned records and integrating them
Long term record storage and retrieval
Dr Charlie Sodano,
Records & Information Management Consultant ,
Hands-on Records and Information management specialist with a proven record of success for providing creative solutions with bottom line results. Subject Matter Expert (SME) in the pharmaceutical and consumer food products industries. He has worked with the legal community in eDiscovery cases applying computer assisted review technology utilizing his SME background to screen and filter information deposed for litigation.
Principal at eOrganizedworld consultants where he has served several long term engagements with Elan Pharmaceuticals (2007 - 2012) and Nektar Therapeutics (2008 - 2015) serving as corporate records and information manager.
Key accomplishments were establishment of a global record retention schedule, centralization of all electronic records and reduction of redundancies vastly improving the information utilization efficiency of all functional departments; Legal, Finance, R&D, Regulatory, Pharmacovigilance, Production and IT.
While at Berlex Biosciences and Bayer HealthCare Pharmaceuticals (1997 - 2007) as manager of information services launched a global Electronic Notebook system for R&D that was rolled out globally. In addition, managed all global R&D records and information resources.
At RJR Nabisco (1985 - 1997) conducted basic food research, optimized production process at diverse production facilities via the application of analytical measurement process control and managed a program to find and implement new technologies and products into the portfolio of the company’s businesses. One such implementation resulted in cost savings of more than $2 million.