Integrated Compliance Information

EPA enforcement statistics from the Integrated Compliance Information System are available through http //www.epa-echo.gov/echo/compliance report icis.html... 

ECHO provides communities with important enforcement and compliance information about regulated facilities. ECHO integrates information about facilities from separate media-specific data systems. Much of this data has not been accessible in an easily understandable and searchable format, and users can now view this data in a comprehensive and organized manner. ECHO allows users to sort and analyze data in many ways, according to their needs. Now the public can monitor environmental compliance in communities, corporations can monitor compliance across facilities they own, and investors can more easily factor environmental performance into their decisions. 

This book, relevant to FDA-regulated operations, provides practical information to enable compliance with computer systems validation requirements, while highlighting and efficiently integrating the Part 11 requirements into the computer validation program. The ideas presented in this book are based on many years of experience in the United States Department of Defense and FDA-regulated industries in various computer systems development, maintenance, and quality functions. 

Compliance assessments for computer systems are performed periodically, based on the applicable predicate regulatory and Part 11 requirements. These assessments must be performed in order to identify any functional gaps, and/ or procedural gaps, which may be present for each computer system implemented. The analysis will determine if operational, maintenance or security controls, specific to the system, provide a controlled environment ensuring the integrity of the electronic records and/or signatures as stated in the regulatory requirements. Additional information can be found in Chapter 19. 

Quality checks of submissions are critical to ensure that methods, processes, equipment, and facilities have been accurately reported and that the documents included in the submission represent the appropriate scope of information. In addition, the actual data presented in the submission must be checked for integrity and accuracy to the extent possible. The submission of inaccurate or fraudulent documents could result in the invocation of the fraud policy or the application integrity policy (AIP) that covers the failure to have and implement systems or procedures to ensure the quality and accuracy of submissions. It is therefore clear that ensuring the quality of submissions and authenticating all data is critical to maintaining the good compliance standing of the applicant. 

Narrowly focused, the tenets of 21 CFR 11 are indisputable that firms must establish and maintain the integrity of their electronic information. What has been lost is the clear indication of which electronic information the requirements apply to. In my opinion, data generated outside a computerized system, that are manipulated by that system and are ultimately available in hard copy should not be subject to this ruling. Validation of the computerized system should be more than sufficient to establish that the final documentation accurately reflects the input information. In that instance, the computerized system is little more than a tool whose functionality can be readily established, yet firms are endeavoring to assure 21 CFR 11 compliance for numerous systems in which the computer is little more than an adjunct to the cGMP activity and corresponding hard copy. Batch record preparation, SOP and test method archives, and many process equipment control systems are examples of systems in which requirements for 21 CFR 11 compliance appear excessive. A system that processes or communicates data or records and subsequently retains and stores hard copies should not be subject to the 21 CFR 11 requirements. Far too many systems are being unnecessarily held to the very restrictive portions of 21 CFR 11. Electronic record retention as defined in 21 CFR 11 has its place, but not necessarily in every computerized system used within the industry. 

Until quite recently, there was little integrated management of these multiple regulatory requirements because (1) the regulations themselves did not recognize the potential value of such integration, (2) sufficient information about multimedia releases was not available, and (3) relatively short compliance time frames did not allow time for more integrated analysis. 

Another facet, obviously, is to deal with the patient whose compliance has been substandard and take effective action to make as much improvement as possible in drug intake, and to switch, if necessary, to the agent whose therapeutic actions are least influenced by lapses in dosing. These are, of course, new issues that have previously not been considered in drug evaluation, for the simple reason that reliable measures of patient compliance have not previously been available. The potential roles of pharmacists, nurses and other health professionals remain to be defined as this new information and its implications become available and integrated into clinical thinking. 

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