Benefits to Regulatory Specialists in Regulatory Agencies and Regulatory Affairs Departments:

 

From its beginning, a top priority of CENSA has been to develop detailed specifications and strategies for policies and procedures for electronic records management and archives management, and to do so in such a way that we achieve widespread acceptance from domestic and international regulatory agencies and industries for these specifications and strategies.  This work has been paving the way for usage of electronic records by most organizations in all areas of business, not just R&D.  In fact, where they are receptive, specifications from CENSA - and a related standards organization, The Global Electronic Records Association (GERA) - are being given to regulatory agencies to review and use internally. Government regulatory and administrative agencies face their own major internal challenges to become more efficient and use fully electronic records instead of paper.  It is a major challenge for any large organization to make this paradigm shift from paper to electronic systems. We have assisted several government regulatory and administrative agencies with their specifications and regulation development work.  

Electronic recordkeeping technologies will simplify the processes required for organizations to meet legal and regulatory requirements, and help make regulatory audits less painful.  Easier management of records and documentation will help companies gain a competitive edge through their enhanced ability to meet regulatory requirements and achieve operational excellence, e.g., through ISO9000 and other certifications.

Collective "Statements of Best Practices" and Standard Operating Procedures (SOPs) for electronic R&D recordkeeping advances and documents your "state-of-the-art" by providing useful strategies, policies, procedures, and benchmarks for electronic recordkeeping.  CENSA's materials and supporting technologies will help your organization to institute these practices more easily.  Where appropriate, CENSA works to get its standards adopted by formal standards organizations, such as AIIM, ARMA, ANSI or ISO, or to embrace and apply their standards where it makes sense.

The US Patent Office and Trademark Office (PTO), the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), the US National Archives and Records Administration (NARA) and other government regulatory and administrative agencies have already provided content, feedback and direction on CENSA's and GERA's deliverables.  These and many other government agencies have responded favorably upon reviewing the detailed deliverables that have results from our work.  Early and ongoing review of deliverables by regulatory agencies helps to ensure that CENSA member organizations develop acceptable strategies, policies, and procedures.