Responding to increasing demand for compliant IT infrastructure solutions in highly regulated industries, Symmetry, a leading enterprise application management and cloud hosting solutions provider, today announced it has achieved Title 21 CFR Part 11 compliance for its SAP HANA® cloud infrastructure and associated SAP operations.
21 CFR Part 11 establishes United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures in FDA regulated industries.
“The 21 CFR Part 11 regulation was created to maintain the reliability and integrity of electronic records so they are equivalent to paper record submissions,” said David Evans, Founder of Evans Consulting. “It requires regulated companies to implement controls in order to maintain FDA compliance including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data. Symmetry’s ability to manage complex SAP HANA environments, and provide 21 CFR Part 11 compliance is an important development – particularly for rapidly growing pharmaceutical, life sciences, and biotech companies.”
Symmetry’s expanding compliance capabilities are built upon an innovative Quality Management (QM) Program comprised of numerous compliance policies, standard operating procedures, and forms that fully adhere to regulations. This includes documented procedures, staff training records, system risk assessments, and change control/validation programs that are led by an experienced quality team.
Unlike other hosting and cloud infrastructure providers who pay lip service to compliance by doing the bare minimum or by cobbling together the basics to support client audit requests, Symmetry’s QM program brings together training, document control, data storage, security and auditing in a comprehensive governance framework that enables Symmetry to demonstrate compliance in real-time for companies in highly regulated industries, such as Pharmaceutical, Life Sciences, Biotechnology and Healthcare.
Together with Symmetry’s Cyber Security practice—which combines secure infrastructure with Security Information and Event Management (SIEM), a 24x7x365 Security Operations Center, and a wide array of threat analysis, incident response, remediation and forensics—Symmetry is one of the few Cloud Hosting and Application Management companies that can truly engineer comprehensive solutions engineered to meet the exact performance, security and compliance solutions for today’s enterprise.
“Comprehensive, continuous compliance is now a requirement across all verticals and all industries, and it is mandatory to ensure sustained security while enhancing customer value,” said Pete Stevenson, Chairman and CEO of Symmetry. “For clients to trust their mission critical applications with a service provider, it’s vital to be capable of documenting what you do on the front end and then validating exactly what you actually did on the back end. That’s the approach behind Symmetry’s Quality Management program and regulated companies should expect nothing less.”