Good Clinical Practice (GCP) regulation requires that the manufacturing of any Investigational Medical Product (IMP) or Medicinal Product (MP) follows Good Manufacturing Practice (GMP), regardless of where it is being performed. Our consultants can ensure that your products comply with GMP requirements (EudraLex Vol. 4, Annex 11) by qualifying your IT Infrastructure.
Based on our template for impact and risk assessment within the pharmaceutical, biotech, and medical device industries, we can help you minimize costs by finding the balance between simple solutions and risks while ensuring compliance.
We can support in building a standards-based setup where infrastructure standards are created to ease the daily support and maintenance of the infrastructure.
Pharma IT can provide template SOPs that provide the basis for the qualification of infrastructure. These SOPs should be aligned with producers for the validation of computerized systems.
Through our partner network, we can provide support in delivering hardware, as well as implementation and providing support and maintenance for a qualified infrastructure.
We can provide you with a tailored, reasonable, secure, risk mitigated, and compliant infrastructure. Our consultants provide services to companies of all sizes with laboratories and/or production lines, for the production and control of intermediates, and finished products related to Investigational Medical Products and Medical Products.
Good Clinical Practice (GCP) regulation requires that the manufacturing of any Investigational Medical Product (IMP) or Medicinal Product (MP) follows Good Manufacturing Practice (GMP), regardless of where it is performed. Our consultants can ensure that your products comply with GMP requirements (EudraLex Vol. 4, Annex 11) by qualifying your IT Infrastructure.
Based on our template for impact and risk assessment within the pharmaceutical, biotech, and medical device industries, we can help you minimize costs by finding the balance between simple solutions and risks while ensuring compliance.
We can support in building a standards-based setup where infrastructure standards are created to ease the daily support and maintenance of the infrastructure.
Pharma IT can provide template SOPs that provide the basis for the qualification of infrastructure. These SOPs should be aligned with producers for the validation of computerized systems.
Through our partner network, we can provide support in delivering hardware, as well as implementation and providing support and maintenance for a qualified infrastructure.
We can provide you with a tailored, reasonable, secure, risk mitigated, and compliant infrastructure. Our consultants provide services to companies of all sizes with laboratories and/or production lines, for the production and control of intermediates, and finished products related to Investigational Medical Products and Medical Products.