Quality management for Life Science

Standard software that conforms to GAMP 5 for FDA and GxP compliance.

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DHC Ventures

DHC VISION for young companies and research projects on their way to becoming a start-up.

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CAPA, Deviations, and Complaint Software

Securing GxP compliance with DHC VISION closed loop processes

DHC VISION software for CAPA, deviations, and complaint management reduces the number of quality issues; it cuts down on the frequency of product recalls; and it minimizes related costs significantly. So-called “non-conformities” refer to deviations, deficiencies, complaints, material defects, “out of specification” (OOS) and “Out of tolerance” issues; they include problem reports from inspections as well as audit findings. “Non-conformities” trigger detailed analyses and diagnoses. They lead to measures taken in order to eliminate causes. Measures, then, need thorough evaluation of their effectiveness. Reliable CAPA management directly combines corrective actions with preventive actions.

DHC VISION relates „non-conformities” to corrective and preventive actions in order to remove causes of any kind of deviation. The software supports the complete problem-solving process – from reporting non-conformities to the formal closure of the reported problem. Visual, role-based support is provided for tasks, worklists, and recommendations for actions.

DHC VISION contributes significantly to the efficiency of operative and quality-related processes. Electronic signatures and detailed audit trails secure compliance with 21 CFR Part 11. DHC VISION integrates with operative systems to a company-wide, standardized management of quality issues, taking into account sector-specific industry standards and regulations.

DHC VISION CAPA, deviations and complaint management is a perfect match for processes in the pharmaceutical industry, in biotechnology, the medical devices, chemical, cosmetics, and food industries as well as other highly regulated industry sectors. It complies with all specific legal and regulatory requirements in this area and safeguards compliance with GMP regulations. In particular, it avoids defects according to 21 CFR § 211.192, i.e. insufficient investigation of the causes for such defects and remediation to deficiencies detected.

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