Qualification of Infrastructure

Ensuring GMP compliance through tailored, secure, and risk mitigated solutions

Qualification of Infrastructure

Ensuring GMP compliance through tailored, secure, and risk mitigated solutions

Our consultants are GMP experts and ready to assist you with the Qualification of Infrastructure

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.

Person Ensuring GMP Compliance

We can provide end-to-end support of your IT Infrastructure



Design

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.



Build

We can support in building a standards-based setup where infrastructure standards are created to ease the daily support and maintenance of the infrastructure.



Qualify

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.



Execute

Through our partner network, we can provide support in delivering hardware, as well as implementation and providing support and maintenance for a qualified infrastructure.

Pharma IT services are tailored to meet your needs

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.

Our consultants are GMP experts and ready to assist you with the Qualification of Infrastructure

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.

We can provide
end-to-end support of your
IT Infrastructure



Design

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.



Build

We can support in building a standards-based setup where infrastructure standards are created to ease the daily support and maintenance of the infrastructure.



Qualify

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.



Execute

Through our partner network, we can provide support in delivering hardware, as well as implementation and providing support and maintenance for a qualified infrastructure.

Pharma IT services are tailored to meet your needs

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.

Want to know more about how we can assist you with IT Infrastructure Qualification?

Pharma IT can provide a tailored solution to help you remain compliant

Want to know more about how we can assist you with IT Infrastructure Qualification?

Pharma IT can provide a tailored solution to help you remain compliant