Computer System Validation Services for the Life Sciences Industry

Man holding a virtual sphere that reads VALIDATION

Meeting All Regulatory Needs of Pharmaceuticals, Biotech, and Medical Devices by Delivering Flawless Computer System Validation Services

Computer system validation is a fundamental requirement for the pharmaceutical, biotech, and medical device industries.

We take to heart the life-saving work that pharmaceutical, biotech, and medical device 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 365™ offers continuous validation scheduled on a biannual basis.

AX for Pharma 365™ has designed the framework around best practices and compliance strategies for pharmaceutical, biotech, and medical device 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 365™ 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 365™, natively integrated with 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 365™ 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