Audit Management Software
Planning, conducting and analyzing audits and measures – a sustainable supplement to quality management
The audit management software DHC VISION supports all phases of the audit management process – from designing audit criteria and audit programs (schemas) to preparing, conducting, documenting, evaluating and monitoring audits and, finally, to defining and tracking follow-up activities as well as corrective and preventive actions. All steps within the audit process are automated via the system’s workflow engine.
Regardless of industry sector and company size, the audit management add-on component to the DHC VISION process and quality management solution suits a broad range of areas of application on a single, integrated management environment. This holds for quality management as well as for other sets of standards in areas such as environmental or hygiene management as well as security and protection management (occupational health and safety, factory security, fire protection, information security). DHC VISION provides functionalities for all kinds of norms and regulations; it supports internal as well as external audits and processes; and it facilitates a systematic management and steering approach. The audit management software covers a broad variety of audit types, i.e. process, product, and system audits as well as customer and supplier audits, control audits, repeat audits, Third Party and GxP audits.
In addition to pre-defined, norm-compliant question catalogues, customized catalogues are available to facilitate audits. DHC VISION is highly flexible when it comes to defining catalogues and checklists, their level hierarchy and evaluation schemes. This is how the software is able to accomodate company- or department-specific audit scenarios. The DHC VISION content framework hosts catalogues for different norms and standards. The audit management software also supports audits without question catalogues or checklists, e.g. audits based on qualitative interviews.
Audit plans clearly visualize all relevant audit information as well as the status and schedule of individual audits. An overview of all activities and related dates within the audit processes are shown to the day. Information on deviations between target and actual figures facilitate audit planning in the future.
Comprehensive reports, analyses for a given date, ad hoc and progress reports are available to plan and monitor audits, findings, and follow-up measures. Dashboards with standard apps provide real-time data to all relevant aspects and processing states. This is how the audit management solution ensures complete traceability and continuous monitoring of all activities in addition to benchmarking studies for different scenarios.
Digital audit management in highly regulated industry sectors (FDA, GxP, ISO)
In FDA and ISO regulated industry sectors, companies are required to comply with quality specifications, requirements, and regulations in a verifiable way. Relevant standards and regulations are, e.g., 21 CFR 820, 21 CFR 211, 21 CFR 606, 21 CFR Part 11 or ISO 13485. They are legal or official requirements covering professional as well as technical aspects. DHC VISION audit 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. On a technological level, it complies with 21 CFR Part 11, among others. DHC’s “Validation Accelerators” and validation services ensure a lean software validation process.