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ZenQMS is committed to achieving the highest data privacy and security standards for its clients and making qualification easier
ARDMORE, PA, UNITED STATES, November 21, 2022 /EINPresswire.com/ — ZenQMS, a leading provider of electronic quality management systems (“eQMS”) for Life Sciences companies around the world, announced it has received its SOC 2 Type II certification audit report with no exceptions.
SOC 2 Type II assessments require vendors that handle sensitive data to undergo an independent cybersecurity audit by an approved third-party auditor. This auditor certifies the vendor has sufficiently met relevant American Institute of Certified Public Accountants (“AICPA”) Trust Service Criteria in one or more of five trust principles: Security, Availability, Processing Integrity, Confidentiality, and Privacy.
ZenQMS has further distinguished itself as the premium cloud-based service provider by meeting the requirements of all five principles.
“Successfully completing this SOC 2 Type II audit certification is yet another milestone in our compliance roadmap and continuous improvement activities,” said Panos Boudouvas, CEO. “As a company, we have a responsibility to walk in our customers’ shoes from a compliance perspective, and we continue to set the highest bar in the eQMS industry, going beyond a basic GxP compliance profile with certifications that include ISO9001, ISO27001, GDPR, and HIPPA. We want our clients to see that our commitment to quality standards meets or exceeds their own..”
“We’re thrilled to have completed this important step,” said ZenQMS VP of Quality Assurance, Karin Ashkenazi. “It is a testament to the time and effort we’ve put into building a safe, reliable and secure application that clients can trust. The reality today is that SOC 2 Type II, along with ISO 27001 and certifications for GDPR and HIPPA are the standards all eQMS providers in Life Sciences must meet. It’s not up for debate. The data, documents, and electronic documents are too critical to be trusted to anything less.”
Per the AICPA, the auditing procedure used to build SOC 2 evaluation reports is administered at two levels:
1) SOC 2 Type I reports describe a service organization’s control systems and whether they meet appropriate trust principles at a specific moment in time.
2) SOC 2 Type II reports require more rigorous testing and documentation, as the operational effectiveness of the system is addressed over a 6-12 month period.
As an eQMS provider for organizations in strictly-regulated environments, ZenQMS understands these expectations well. Mr. Boudouvas clarified, “You have to earn a client’s trust every day. During our discussions, we not only demonstrate how ZenQMS meets or exceeds GxP requirements per GAMP 5 and 21 CFR Part 11 guidelines, but we also show empathy for how difficult it is for them to satisfy the most rigorous compliance frameworks. To be frank, eQMS companies that don’t maintain a broad and technically-challenging set of standards just make it harder for clients to deploy applications. Qualification and validation of a SaaS platform is the vendor’s responsibility– and so is making it easy for a new client to accept and build on that for its own qualification.”
Ms. Ashkenazi added, “I’m biased of course, but as the one responsible for hosting over 100 GxP audits a year and meeting a wide array of compliance standards, I know it would be impossible to do so without an eQMS. This is especially true for my small team. We love the ZenQMS application, and so do the auditors who find answers to their questions at their fingertips.” Learn more from Karin on Soc 2 as well as the evolving shifts from the FDA and GAMP organization on computer software validation at this upcoming Quality Leaders Forum event.
Headquartered in suburban Philadelphia, ZenQMS is a 100% cloud-native application helping Life Sciences companies that want an easy-to-use, affordable way to maintain compliance with GxP and ISO requirements. ZenQMS offers a unique approach to client engagement and pricing, including turnkey implementation and customer-friendly annual fee that includes access to the whole platform and scales as clients grow. The software stresses simplicity and versatile configuration options to meet a client’s unique needs, and comes with in-house support at no additional cost. Clients don't need an IT team or large QA team to purchase, implement, or manage ZenQMS.
Learn more or book a meeting at www.zenqms.com or email [email protected]
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