HealthCarePoint follows an array of compliance guidelines including the document 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records “Draft Guidance For Industry” prepared under the aegis of the Office of Enforcement by the FDA Part 11 Compliance Committee. The committee is composed of representatives from each center within the Food and Drug Administration, the Office Counsel and the Office of Regulatory Affairs.
SUMMARY: A secure, reliable environment that maintains hosting, physical security, logical security via a SUNGUARD-SSAE-16-SOCI certified hosting facility. Renewable disaster recovery plans and redundant back up processes are in place. Additional redundant processes and infrastructures can be added on a case by case basis. Agile software methodology processes is used when creating new software and technology improvements. Whenever required, each separate HealthCarePoint’s networking vehicle can adapt independently to an array of electronic signature requirements as per a series of continuously virtually and locally audited and proprietary Standard Operating Procedures (SOPs). Using proper channels and proper procedures, SOPs can be demonstrated to VIP industry auditors which require such virtual and on-site proof of vendor audits. HealthCarePoint’s proprietary networking software is and will continue to be created in-house to minimize the risk of infiltration which is tested via third party tools and testing technologies. HealthCarePoint’s Primary Engines and Networking Systems are not created using open-source technologies.