Compliance Efficiency
Compliance Efficiency
“Compliance & Efficiency sounds like a contradiction, right? Most organizations are pulling either in the one or the other direction, depending on where the current pressure comes from. We show you how to stop this ping-ponging and integrate the compliance and efficiency spheres.“
Compliance Efficiency
“Compliance & Efficiency sounds like a contradiction, right? Most organizations are pulling either in the one or the other direction, depending on where the current pressure comes from. We show you how to stop this ping-ponging and integrate the compliance and efficiency spheres.“
What we deliver.
We support you by determining the state-of-the-art standards of compliance in your regulatory environment and efficiently tackle any identified compliance gaps. Our global network of compliance advisors covers all subject areas of quality and risk domains, ranging from product to systems quality, along the total product life cycle and across the entire quality and control system.
What we deliver.
We support you by determining the state-of-the-art standards of compliance in your regulatory environment and efficiently tackle any identified compliance gaps. Our global network of compliance advisors covers all subject areas of quality and risk domains, ranging from product to systems quality, along the total product life cycle and across the entire quality and control system.
Quality Oversight.
Always start here. Frequently we observe our customers struggling with micro-problems due to the lack of an over-arching Quality Management System derived from a process landscape (not from an orgchart!). Most important prerequisites: a practiced knowledge management and an entire staff trained on a regular basis to eg. fully understand the complex correlations between the different levers of your Quality Management System.
We know – a lot of work at the very beginning. But trust us: it is worth it, when completed in an efficient way.
Quality Oversight.
Always start here. Frequently we observe our customers struggling with micro-problems due to the lack of an over-arching Quality Management System derived from a process landscape (not from an orgchart!). Most important prerequisites: a practiced knowledge management and an entire staff trained on a regular basis to eg. fully understand the complex correlations between the different levers of your Quality Management System.
We know – a lot of work at the very beginning. But trust us: it is worth it, when completed in an efficient way.
Most common pitfall: your QM System is too complex and workarounds are more popular than following SOPs. Therefore, it is obligatory to select, prioritize and finally balance the most important QM influencing factors coming from
3 dimensions: 1. Customer Requirements (eg. via complaints handling) 2. Business Impact
3. Regulatory Standards. Only so you will be able to build a system that is based on holistic and transparent Out-of-Specification measurements.
Always keep in mind: Quality Management doesn’t mean to act on retrospective failures but to be able to anticipate upcoming events and steer your organization/process pro-actively in the right direction. Therefore, the entire organization must understand how to detect deviations from your regulatory requirements and most importantly: how to act accordingly.
Quality Management.
Quality Management.
Most common pitfall: your QM System is too complex and workarounds are more popular than following SOPs. Therefore, it is obligatory to select, prioritize and finally balance the most important QM influencing factors coming from
3 dimensions: 1. Customer Requirements (eg. via complaints handling) 2. Business Impact
3. Regulatory Standards. Only so you will be able to build a system that is based on holistic and transparent Out-of-Specification measurements.
Always keep in mind: Quality Management doesn’t mean to act on retrospective failures but to be able to anticipate upcoming events and steer your organization/process pro-actively in the right direction. Therefore, the entire organization must understand how to detect deviations from your regulatory requirements and most importantly: how to act accordingly.
Quality in Operations.
When your Quality Oversight and QM System are up and running, focusing on Operations Compliance (including Logistics and Equipment in the manufacturing industry) is the logical next step. This ranges from HSE and how to avoid process risks to how to comply with the specific operational regulatory requirements of your respective industry (eg. GxP or GDP in Life Science).
Together with you we conduct compliance gap assessments (eg. with mock audits) and help you to set up remediation programs if necessary. Don’t tell anybody but the goal is to get you in shape before your regulator got word of it!
Quality in Operations.
When your Quality Oversight and QM System are up and running, focusing on Operations Compliance (including Logistics and Equipment in the manufacturing industry) is the logical next step. This ranges from HSE and how to avoid process risks to how to comply with the specific operational regulatory requirements of your respective industry (eg. GxP or GDP in Life Science).
Together with you we conduct compliance gap assessments (eg. with mock audits) and help you to set up remediation programs if necessary. Don’t tell anybody but the goal is to get you in shape before your regulator got word of it!