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Electronic Signatures/Electronic Records Applied Control Engineering offers multiple services with respect to 21 CFR Part 11 (Electronic Records, Electronic Signatures, Final Rule). These services range from initial project design to full turnkey solutions. As many of the legacy systems currently in use are not compliant with 21 CFR Part 11, ACE's first offering is a gap analysis. In a gap analysis, we will examine the systems in question and determine if there is compliance with Part 11. ACE will deliver a report detailing our findings and indicating which portions of the system are in need of remediation. Remediation is the second offering from ACE. Based upon the results of a gap analysis, ACE will provide remediation services to bring a non-compliant system into compliance. These services may be DCS configuration, HMI configuration, operating system configuration, or database configuration. In addition, ACE will provide assistance in the drafting of SOPs and the training of system administrators and end users. For those systems not yet implemented, ACE can provide specification development to ensure that new systems are compliant. With our understanding of the requirements, ACE is able to assist the user in developing a URS or writing a FRS that satisfies the requirements of Part 11. In addition to developing specification documents, ACE can implement turnkey projects ensuring that the design and implementation of the system are Part 11 compliant. ACE realizes that 21 CFR Part 11 is an integral part of any GMP system and actively works to keep our employees current with developments. This includes participating in committees, attending seminars, reading literature, and talking with our vendors. |