DEVIATION MANAGEMENT

• Interactive data analytics scenarios for diagnosing the state of affairs in deviation management
  • Overviews of deviations related to, e.g., ingredients, batches, manufacturers/suppliers
  • Presentation of relevant aspects, e.g., the severity level, over time and comparisons over time periods
  • Drill-down options to product level
  • Visualization of number of affected products, batches, ingredients, suppliers, etc.
• Provision of a so-called datamart; pool for data import and data use in existing BI systems
• Role-specific dashboard for management with clear representations of meaningful or decision-relevant real-time information
  • Number of deviations and breakdown by priority and status
  • Visualization of the remaining time of deviations and the remaining time of measures with 45-day forecast showing the status as well as overdue items
  • Number of immediate actions, number of corrective actions, number of preventive actions
  • Breakdown to the respective status, incl. number of deviations, “open”, “in implementation” and “for effectiveness review”.
  • Drill down to the deviation level with status information on measures, documents, responsibilities and display of the trigger, workflow status, priority and due date
  • Navigation to the level of individual tasks with status information (triggering object, affected object, task type, responsibilities)
  • Clear display of all tasks (according to selected selection parameter) with task attributes or properties, risk, evaluation, workflow status and completion date
  • Deep Access to existing activities or workflow tasks
  • Direct access to the specific measure or deviations with a view of all multi-perspective core information such as sub-measures, additional information, the triggering objects, affected objects or the graphical measure life cycle with PLAN/ACTUAL comparison

• Controlled deviation management with fully traceable, systematized processes
• Use of electrical signatures and audit trails for compliance with 21 CFR Part 11 and Annex 11
• GxP-compliant implementation including standard validation templates and methodology
• Ensures compliance to regulatory requirements from laws or standards
• Easy configuration (DHC VISION complies with GAMP® software category 4)
• Reminders and escalation mechanisms
• Automated e-mailing with sufficient interval to upcoming deadlines or due dates
• Audit-proof storage of information and data
• Flexible authorization concept to ensure the highest security standards
• Web-based for easy and worldwide access – also via mobile devices
• Comprehensive master data management for processes, organizational units, IT systems, products, machines, projects, buildings, etc. or for setting up error or cause catalogs

• Intelligent client concept for mapping international group structures
• Realization of a group-wide, harmonized deviation management
• Clear management of wide-ranging deviation activities and global or site-specific error, cause and action catalogs
• Intuitive translation of deviation documentation and reports, including formal approval of the language variant via separate translation profiles
• Language packages for international use; standard scope of delivery: DE and EN
• Tools for translating the software interface into all Unicode-capable languages
• Easy switching between languages

In very general terms, a deviation is understood as the non-fulfillment of a desired regularity or a standard condition. The term is used in domains such as cost control or statistics; in quality management, it usually refers to the difference between an agreed target, a planned value, or target state on the one hand, and the actual value or actual state on the other. In regulated industries, deviations are often quality anomalies or defects, out of specifications, non-conformities, or process deviations. In the broadest sense, such phenomena are deviations from the defined target state, e.g., deviations in the recipe, the filling quantity, or technical process parameters in production. In the life sciences, such deviations generally trigger further investigations. It is important to discriminate deviations from “changes”: Deviations are unplanned; changes, by contrast, are planned.

To give an example: Even a change of a few millimeters in the folding direction of the package insert in a drug box triggers a deviation process. The stance of regulatory authorities such as the FDA or EMA toward the detection of deviations is: Once deviations are identified, they must not be covered up or downplayed; rather, detailed investigations are required – and they have to be documented.

When analyzing deviations, it is important to first separate what is “conspicuous” or “extraordinary” from what is “less important”. Then, it is possible to focus on appropriate actions to eliminate the causes of such conspicuities. Prompt action can prevent greater damage, for example, if individual batches have to be blocked for delivery. There is a fluid transition from detecting irregularities to remediate actions, i.e., from the deviation to the CAPA process.

Deviations, e.g., in everyday pharmaceutical work, are mass phenomena; they quickly reach unmanageable dimensions. The deviation process must meet high standards; shortcuts or improvised approaches to solutions are not allowed. At the same time, many people are involved in the deviation process. The deviation process, thus, is complex. This is due also to the close interlocking with other processes such as corrective actions; additional complexity is added through the dependencies on “long-term measures” in place. Therefore, paper-based methods cannot cope with the flood of information and the complexity of the tasks.

Software for deviation management supports thorough documentation in line with regulatory requirements; it automates relevant workflows, from the first to the last step.

Every deviation, as well as every complaint, is initially a risk and thus a potential damage. Classifying a deviation in terms of criticality provides an initial assessment and, thus, an indication of the damage it may cause. Quality site reports cover deviation analyses in all conceivable cross-relationships to products, raw materials, processes, and suppliers.

Here, too, management reports follow the top-down approach of the information pyramid. Here, the first thing of interest is an overall view of the current deviation situation, and this is always target group-specific in the data aggregation. How many deviations are currently in which processing status? What trend is discernible? Is there an increase or decrease in deviations and the associated number of deviations? Do the number of still open deviations predominate or are the majority of deviations already in the effectiveness review? Which deviations are overdue for processing? Are accumulations of deviations detectable at certain company locations?

As always with such metrics and reports, it’s all about complete traceability and regulatory compliance.