Expertise
Corporate Quality System Development
Integrating, standardising and centralising multiply independant Quality Management Systems or operational processes is highly complex and requires a balance of project management, technical expertise and people change management. Our consultants are experts at facilitating organisational change and providing guidance through the process of developing and integrating global regulated systems.
Electronic Quality System Implementation
Our consultants can provide expertise, project management, validation and facilitation services to implement GxP compliant software solutions such as PLM (Product Lifecycle Managment), MES (Manufacturing Execution Systems), LIMS (Laboratory Informatics Managment Systems), ERP (Enterprise Resources Planning), RMS (Requirement Management Systems, CRM (Customer Managment Systems, DCS (Document Management Systems.
Process Excellence & Six Sigma
Process Improvement and innovation requires a strict methodical expert guided approach such as DMAIC (DEFINE - MEASURE - ANALYSE- IMPROVE - CONTROL) or DMADV (DEFINE - MEASURE - ANALYSE- DESIGN - VALIDATE). Our Black Belt certified Six Sigma practitioners can provide this leadership and facilitation to resolve process, system or product improvements or innovations.
Quality Scorecards, KPIs and Dashboards
Data driven decision making is critical in order to operate an efficient and effective regulated organisation. Distilling this information into meaningful validated outputs can be challenging and complex. Our team is very experienced in creating global visual automated outputs that are meaningful and add substantial value and reduce the burden of manually assessing this data.
Independent Auditing & Due Diligence
Regulations and standards continue to dramatically evolve and challenge even the most organised regulated businesses. Compliance is a critical element of Corporate risk profiling and regular planned and unplanned audits and inspections are a necessary activity to provide corporate oversight and product, process and people quality assurance. We can deploy global Independent certified auditors across the globe to assess against a variety of regulations and standards such as ISO9001, ISO13485, FDA 21 CFR Part 820 and part 11 and against the new MDR (Medical Device Regulations).