Computer System Validation Services for the Life Sciences Industry

Man holding a a tablet with a check indicating VALIDATION

Flawless Pharma, Biotech, and Medical Device Computer System Validation Services

Computer system validation (CSV) is a fundamental process required to meet regulatory requirements. This process, and the regulations that it supports, must be a top priority for pharmaceutical, biotech and medical device industries, regardless of size, location, specialization, or any other factor.

We take to heart the life-saving work that pharmaceutical, biotech, and medical device companies contribute to the world, and we recognize how complex and important CSV is in the life sciences. All of this motivates us to be confident that our methodology for computer system validation in life sciences meets the highest industry standards. By leveraging Computer Software Assurance (CSA), AX for Pharma is engaging in a more pragmatic approach to CSV, based on critically assessing all relevant risks, and confirming that testing, documentation, and evidence collection align with the risks that have been identified, thereby ensuring that patient and product safety are in place, as well as the data integrity required to maintain the system’s ability to be considered fit for its intended use.

Additionally, AX for Pharma 365™ offers continuous validation for pharma, biotech and medical device manufacturers scheduled three times a year.

AX for Pharma 365™ has designed a 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, project cost, and level of compliance required.

AX for Pharma 365™ also provides a ready-made set of validation documents and templates. It makes regulatory compliance in the pharma, biotech, and medical device industries that much easier to achieve and maintain.


  • GxP compliant ERP systems and processes.
  • Compliance with FDA, EMA regulatory requirements and guidelines (21 CFR part 11, Annex 11, GDPR, GMP).
  • To ensure supporting computer systems are fit for their intended use, AX for Pharma follows a risk-based testing approach while adhering to the GAMP 5 framework.
  • Lowered costs while sustaining reductions for the effort for computer system validation.
  • Security for internal and external audits.

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 regulatory compliance.  Quality assurance and safe products in the life sciences industry start with validated computer systems.

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 compliance to the applicable regulatory requirements.