Today’s science-based companies are very aware of the importance of Quality in conducting a successful business and sustaining competitive advantage. Therefore, many enterprises have a Quality Strategy in place.
Although a Total Quality Strategy is required and executable, the actual implementation might be challenging. Quality has to ensure both Regulatory Compliance and Operational Excellence through high quality processes, documents, materials and products underpinned by meaningful metrics. At the same time processes need to be streamlined and cost efficient to reduce compliance costs and cost of poor quality.
Some procedural challenges that make the actual implementation difficult include:
Quality procedures and processes must be developed and followed consistently.
Enforcing the execution of procedures can be very demanding, especially as it can lead to time-consuming, non-value-add check box activities.
The Quality process needs to ensure that the right input materials of the right quality are used for the right purpose; different purposes may require different specifications of the material used.
All documents need to be managed and maintained throughout their lifecycle in accordance with regulations mandating version control, review, approval, distribution and lifecycle management.
The required data from the different documents and sources need to be quickly aggregated in order to measure and analyze Quality-relevant metrics.
Quality is not just one, or even a series of projects. To have the expected deep impact on an organization, Total Quality requires a behavioural change that is enabled by adequate tools and systems– it must become part of the organizational culture.
When enabled with the right tools and implemented correctly, Total Quality will not only ensure compliance. It will enhance product and process quality and at the same time increase productivity.
The BIOVIA One Quality solution supporting an advanced Total Quality strategy includes capabilities for Quality Process Management, Quality Control and Testing, Materials Quality Management, Quality Document Management and Quality and Process Data Analytics.
The BIOVIA One Quality solution allows customers to:
Have a comprehensive approach for Total Quality that ensures Compliance and Quality Excellence in all Quality relevant areas throughout the entire product lifecycle
Reduce compliance costs and costs of poor quality with a solution that allows for pre-emptive action
Standardize and automate quality processes, increase efficiency and accuracy of business processes and activities and proactively improve business performance
Remove bottlenecks and compliance risks from laboratory-related processes in Development, Manufacturing and Quality through integration, automation and harmonization
Accurately manage materials and samples from receipt to disposal, address EH&S lab safety requirements and reduce regulatory and quality risks, hazards and costs
Ensure enterprise-wide consistency of all quality documentation as well as compliant lifecycle management
Reduce errors, minimize non-value-add manual tasks and improve efficiency by replacing disconnected and/or paper- and spreadsheet-based systems with a solution that integrates key components of the corporate Quality strategy
Improve product and process quality throughout the entire product lifecycle with improved consistency and reliability through enhanced process understanding and knowledge sharing
BIOVIA One Quality increases efficiency, reduces costs and improves quality and compliance by addressing all relevant aspects of an organization’s corporate Quality strategy. When properly implemented, the solution can reduce time-to-market, increase sustainability, protect brand reputation, and enhance competitive advantage.