rightQA.dk gives consulting and practical solutions for biotech, pharma and medical devices companies. With our wide experience from all aspects of quality as well as development, we guide our customers carefully with focus on practical solutions and efficiency.
audits, inspections, due diligences
and quality advice
audits, inspections, due diligences and quality advice
rightQA.dk perform both internal and external audits in:
• GMP: Active Pharmaceutical Ingredients and Excipients
• GMP: Finished Products
• GLP: Animal studies
• GCP: Clinical studies
• Medical Devices: ISO 13485
• Pharma company sales affiliates
• IT
• Participation in Due Diligences
We can also help you to prepare for authority inspections such as FDA
and EU:
• rightQA.dk can be “the host” during inspections.
• We can perform mock audits in advance of the real inspection.
• We have experience from more than 50 inspections in GMP, GDP, GLP, GCP, IT, Pharmacovigilance, and from authorities from all over the world.
Furthermore, rightQA.dk gives professional advice and second opinion about Quality cases and Risk evaluations. With experience from a post as Corporate Vice President for Global Quality in a mid-size pharma company with 5000 employees, a lot of high level experience and good judgement skills has been gained – experience that can help you and your company with advice, sparring and second opinion in a difficult quality situation.
rightQA.dk perform both internal and external audits in:
• GMP: Active Pharmaceutical Ingredients and Excipients
• GMP: Finished Products
• GLP: Animal studies
• GCP: Clinical studies
• Medical Devices: ISO 13485
• Pharma company sales affiliates
• IT
• Participation in Due Diligences
We also do authority inspections such as FDA and EU, and can help you with preparations for- and participations in inspections:
• rightQA.dk can be “the host” during inspections.
• We can perform mock audits in advance of the real inspection.
• We have experience from more than 50 inspections in GMP, GDP, GLP, GCP, IT, Pharmacovigilance, and from authorities from all over the world.
Furthermore, we give professional advice and/or second opinion about Quality cases and Risk evaluations:
• With experience from a post as Corporate Vice President for Global Quality in a mid-size pharma company with 5000 employees, a lot of high level experience and good judgement skills has been gained – experience that can help you and your company with advice, sparring and second opinion in a difficult quality situation.
quality agreements and documents
quality agreements and documents
rightQA.dk can help you to develop your quality agreements, as well as negotiate the quality agreements with your partners.
With practical experience as former Development Director and Quality Director from a small biotech start-up company, we can also offer solutions in the intersection between Quality, CMC and Regulatory. In these areas, we can help with documents and practical solutions, for example when you want to file a new product, or during development.
rightQA.dk can help you to develop your quality agreements, as well as negotiate the quality agreements with your partners.
With practical experience as former Development Director and Quality Director from a small biotech start-up company, we can also offer solutions in the intersection between Quality, CMC and Regulatory. In these areas, we can help with documents and practical solutions, for example when you want to file a new product, or during development.
quality systems and IT systems
quality systems and IT systems
Development and improvement of your Quality Metrics
With Quality Metrics you will get the right KPI´s and facts for compliance. This will give you overview of the high level compliance status in your company. It is the expectations of FDA that you have a range of Quality Metrics.
Quality Management Reviews and Product Reviews
Regular Quality Management Reviews and Products Reviews are legal requirements. We know this can be time consuming and it might be difficult to allocate time in a busy company for these reviews. rightQA.dk can help you to collect the data, develop the written material, and also participate in your Quality Management Reviews and Products Reviews.
Improve all types of quality systems to be more efficient
rightQA.dk can perform sanity checks of your quality systems and come up with proposals for improvement and more efficiency.
Coordination of validation and implementation of IT-systems
A huge task for many companies is validation and implementation of a new GXP critical IT-system. Therefore, we will gladly help to facilitate with high level guidance in validation. rightQA.dk can also work as liaison officer between the pharma company and the IT supplier, to ensure that the documentation is correct.
Furthermore, rightQA.dk can help with preparation of the user request specification for quality related IT-systems. We also collect the required information for single modules of an IT-system.
Development and improvement of your Quality Metrics
With Quality Metrics you will get the right KPI´s and facts for compliance. This will give you overview of the high level compliance status in your company. It is the expectations of FDA that you have a range of Quality Metrics.
Quality Management Reviews and Product Reviews
Regular Quality Management Reviews and Products Reviews are legal requirements. We know this can be time consuming and it might be difficult to allocate time in a busy company for these reviews. rigtQA.dk can help you to collect the data, develop the data, develop the written material, and also participate in your Quality Management Reviews and Products Reviews.
Improve all types of quality systems to be more efficient
rightQA.dk can perform sanity checks of your quality systems and come up with proposals for improvement and more efficiency.
Coordination of validation and implementation of IT-systems
A huge task for many companies is validation and implementation of a new GXP critical IT-system. Therefore, we will gladly help to facilitate with high level guidance in validation. rightQA.dk can also work as liaison officer between the pharma company and the IT supplier, to ensure that the documentation is correct.
Furthermore, rightQA.dk can help with preparation of the user request specification for quality related IT-systems. We also collect the required information for single modules of an IT-system.
quality organization development
and LEAN in quality
quality organization development and LEAN in quality
Development and efficiency in Quality Organizations
With a lot of experience from organization and reorganization of Quality Organizations, including cooperations with McKinsey, we can help you to create an effective Quality organization in your company.
Effective LEAN in Quality
There are a lot of LEAN tools, primarily developed for production
organizations, that have little effect in organizations like Quality. With the high level experience in the industry, rightQA.dk knows how to twist the tools to customize the LEAN tools for the Quality area.
Development and efficiency in Quality Organizations
With a lot of experience from organization and reorganization of Quality Organizations, including cooperations with McKinsey, we can help you to create an effective Quality organization in your company.
Effective LEAN in Quality
There are a lot of LEAN tools, primarily developed for production
Organizations, that have little effect in organizations like Quality. With the high level experience in the industry, rightQA.dk knows how to twist the tools to customize the LEAN tools for the Quality area.