MarkLogic Corporation has retained Lazarus Alliance again to complete its FDA 21 CFR Part 11 audit and attestation.
SCOTTSDALE, Ariz., July 7, 2020 (Newswire.com) - Lazarus Alliance, a top-rated cybersecurity, governance, risk, and compliance (GRC) firm, today announces its support of MarkLogic Corporation, developers of the MarkLogic multi-model NoSQL database. Lazarus Alliance will aid MarkLogic with their FDA 21 CFR Part 11 compliance attestation.
Issued by the FDA in 1997, the 21 CFR Part 11 final rule was designed to permit the widest possible use of electronic technology by mandating security standards for electronic records and signatures. The rule requires that data stored in electronic records be as secure as it would in a paper record. For electronic signatures, the rule requires that both operators and supervisors be able to electronically identify themselves in a manner equivalent to handwritten signatures. Biometrics, such as fingerprint or retinal scan devices, are allowed under the rule. All signatures, both handwritten and electronic, must be linked to their respective records.
“We are pleased to be retained by MarkLogic and look forward to working with them,” said Michael Peters, CEO of Lazarus Alliance. “The MarkLogic database platform is used by many life sciences companies and other organizations that are regulated by the FDA. This attestation ensures that MarkLogic’s clients can themselves achieve FDA 21 CFR Part 11 compliance when developing specific solutions on MarkLogic’s platform.”
To help MarkLogic through the FDA 21 CFR Part 11 attestation process, Lazarus Alliance is using Continuum GRC’s proprietary IT Audit Machine (ITAM), a cloud-based governance, risk, and compliance automation solution. ITAM contains a centralized repository of all IT compliance requirements, with associated controls and automated information flows for audits, assessments, and testing.
“ITAM automates GRC processes, significantly reducing the time and complexity of compliance audits and making it easier for companies to maintain compliance year-round,” said Michael Peters, CEO of Lazarus Alliance.
Source: Lazarus Alliance