Go to Top

compliance enhancement

compliance enhancement

compliance clinics

What it is – Compliance clinics provide scheduled 45 minute slots for SMEs across the site to discuss compliance concerns or project decisions/strategies.  Used either pre-inspection or periodically to support ongoing compliance improvement, these sessions provide access to experienced consultants to discuss a specific project or deviation, practice a storyboard, or ask for advice relating to their department. Rapid discussions, quick turnaround, invigorating engagements!

Who uses it – SMEs and Quality Personnel, Project Managers

inspection readiness

What it is – Our Inspection readiness programme begins with identification of site inspection risks and priority readiness activities.  Once the key concerns are identified our consultants will work with your SMEs to help remediate and position these risks, providing coaching and support for storyboard development.  We provide Inspection Readiness Training and perform mock inspections (with hats on/hats off approach) to ensure all aspects of inspection management are fully prepared and always inspection ready.

Who uses it – Quality Manager, Quality Director, Corporate Compliance

simulated inspections

What it is –  We offer simulated inspections at full scale or at a reduced scale focussing on specific areas of concern. Following simulated inspections, we issue a deficiency report (full or abridged) outlining the details and recommended actions for all observations.  In addition, we can provide a Performance Report evaluating the the “Soft skills” of the company, which can dramatically influence the relationship between the company and the regulatory authority.

Who uses it –  Quality Manager, Quality Director, Corporate Compliance

expert statements

What it is – An expert statement is a formally documented regulatory compliance position signed by an experienced former Regulator. It is constructed using methodical research and structured analysis of all applicable regulations and guidelines relating to the topic under review. It provides an independent, educated, and experienced interpretation of the regulatory compliance position as it pertains to that topic.

Who uses it – Quality Manager, Quality Director

system health check

What it is – The system health check provides a comprehensive evaluation of a Quality Management System design and implementation.  It provides a deep dive assessment of the system lifecycle including system design, training and implementation, lean regulatory compliance, data integrity, trending,  analysis and metric performance, change management, remediation and continuous improvement.

Who uses it – System Owner, Departmental Manager, Quality Manager, Corporate Compliance

deviation system support

What it is – This support provides a range of service options which are designed to ensure a comprehensive and holistic deviation system. It can be used in totality or by selecting elements appropriate to your needs.  The backbone of the QMS, the efficient and effective use of the deviation system can have significant benefits to the overall company performance.

Elements include:

  • A system health check to diagnose and evaluate the full system remediation needs
  • A review of deviation completion to provide a fresh perspective to eliminate blind spots and bias in investigations and reporting
  • Training of Lead Investigators
  • Training of QA Reviewers
  • Risk Based Performance Qualification to Certify Lead Investigator and QA Reviewers
  • Targeted support for trend investigations
  • Deviation clinic support to address backlogs and repeat deviations
  • Data analysis and improvement action identification
  • Advice with story boarding and the presentation of issues to regulators.

Who uses it – System Owner, Departmental Manager, Quality Manager

lean regulatory compliance

What it is – Systems, processes and practices developed by persons with a specific interpretation of the GMPs based on their experiences. Our consultants are in the fortunate position to have seen multiple facilities with different interpretations of the same guidelines, with many of these interpretations being significantly more efficient that common practices.

If you believe that some of your practices or process flows may have been “over interpreted”, let us use our experience to examine them and identity more lean but compliant options.