Regulated industries are required to achieve and maintain compliance status because of applicable regulatory rules and standards. In the digital world, this is no longer just a compliance requirement. It is now an essential part of doing business in the new all-digital, remote work environment. This requires Re-imagining all processes to be able to manage quality, compliance, third-party remote audits in the new remote work environments.
CQRM XD’s QMS Module Xybion Digital Platform XDP with embedded quality and compliance, compliance automation, and risk and quality management. Seamlessly connect your organization with external partners, vendors, and regulators in highly regulated work environments including the FDA.
QMS Module helps global organizations automate, manage, and control compliance and quality process flow including audit, Corrective and Preventive Actions (CAPA), deficiency, non-conformance, customer complaints, training and competency management, incident management, risk, internal control, and more. Embedded Enterprise Content Management and intelligent Business Process Management engine makes CQRM XD’s Quality Module the standard GRCQ X.0 platform for today’s all-remote, all-digital world.
CQRM XD’s Compliance Risk Predictor helps Life Sciences companies conduct quantitative assessments of business risks. The patented solution improves a company’s ability to understand current compliance status, know business risks and prioritize actions making teams more productive and reduces costs.
Compliance Builder is a real-time monitoring solution designed to enable 21 CFR Part 11 compliance, providing data integrity across IT systems such as file systems, database systems, laboratory or manufacturing instruments. By generating an audit trail and enabling electronic signatures, ComplianceBuilder allows you to securely track changes across all IT subsystems including file systems, databases, laboratory, or manufacturing process equipment. It can be configured to monitor any file-based system for changes, including additions, deletions, and file modifications.
Credana is a functionally rich, vertical accreditation solution where partners, external assessors, regulators, customers, and various bodies can all participate effectively. The seamless processing of information and tasks throughout the multi-year lifecycle includes but is not limited to:
The comprehensive accreditation business management solution has allowed greater workforce efficiency, reductions in long-term IT maintenance/costs and provides greater transparency and requisite analytics to gauge performance.
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.