Contact Us

North America

AX for Pharma North America LLC.
100 S. Ashley Drive, Suite 600
Tampa, FL 33602
United States

Europe

AX for Pharma Europe
Centro Direzionale Milano Due
Palazzo Bernini, 701-704
20090 Segrate (Milan)
Italy

Validation Services

Validation Services

Meeting All Regulatory Needs of Pharmaceuticals and Life Sciences by Delivering Flawless Computer System Validation Services

Compliance Strategies
Compliance Strategies
Continuous Validations
Continuous Validations
Validation Documents
Validation Documents

Computer system validation is a fundamental requirement for the pharmaceutical and life sciences industries.

We take to heart the life-saving work that pharmaceutical and life science companies contribute to the world, and it motivates us to be confident that our computer system validation methodology meets the highest industry standards. Additionally, AX for Pharma offers continuous validation scheduled on a biannual basis.

AX for Pharma has designed the framework around best practices and compliance strategies for pharmaceutical and life sciences companies of all sizes. Our team scales compliance policies to match any business model by harmonizing risk evaluation, cost project, and level of compliance required.

AX for Pharma provides a ready-made set of validation documents.

By working with us, our clients attain:

  • GxP compliant ERP systems and processes.
  • Compliance with FDA, EMA regulatory requirements and guidelines (21 CFR part 11, Annex 11, GAMP, GDPR, GMP).
  • Lowered costs while sustaining reductions for the effort for computer system validation.
  • Security for internal and external audits.
  • Validation strategy to implement GAMP 5’s risk-based approach.

AX for Pharma, powered by Microsoft Dynamics 365 ERP, is a state-of-the-art business system that conforms to the set of defined system requirements for computer system validation. Our health and life sciences software ensures accuracy, reliability, and the necessary proven consistency of performance. The AX for Pharma solution includes the critical ability to detect invalid or altered records which is a paramount requirement for computer system validation.

Have questions? Contact us for more information.

Contact Us

North America

AX for Pharma North America LLC.
100 S. Ashley Drive, Suite 600
Tampa, FL 33602
United States

Europe

AX for Pharma Europe
Centro Direzionale Milano Due
Palazzo Bernini, 701-704
20090 Segrate (Milan)
Italy