Life Sciences Cloud Qualification

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Enabling Companies to Stay Audit-Ready with Lean GxP Cloud Validation

The Pharmaceutical and Life Sciences Industry is rapidly transitioning to cloud-based software solutions to increase operational efficiency, realize significant cost-saving benefits and reduce the burden of managing resource-intensive IT  infrastructure.

With this global trend, companies are expected to complete a rigorous vendor qualification and execute computer systems validation to account for GxP compliance and stay audit-ready.

How We Can Help

Cloud Vendor Selection

With our vast experience in technology consulting, we help bio-pharmaceutical companies in selecting the right GxP cloud solution vendor based on their business scope and budget.

Vendor Qualification Audit

Our team of Quality Auditors can conduct a rigorous vendor audit with the required credentials assessment on your behalf and deliver a comprehensive audit report for decision making.

GxP Cloud Qualification

With our vast experience in technology consulting, we help bio-pharmaceutical companies in selecting the right GxP cloud solution vendor based on their business scope and budget.

Continuous Compliance Assurance

Our team of Quality Auditors can conduct a rigorous vendor audit with the required credentials assessment on your behalf and deliver a comprehensive audit report for decision making.

Accelerate GxP compliance readiness for your cloud infrastructure

Compliance with various regulatory standards and compliance requirements is mandatory for all types of Life Sciences/ Biopharmaceutical companies. Controls and adherence to standards related to data security, integrity, and privacy are required to qualify the infrastructure for GxP compliance.

Techsol’s Cloud GxP Compliance Assurance and Qualification services help customers design, implementation, monitoring, ongoing management, and reporting according to Life sciences industry standards, regulations and address validation requirements. The Food and Drug Administration (FDA), European Union Annex 11 and other global equivalent agency regulations require complete and accurate production documentation, quality testing data management, and records to support audit needs as well as accurate process instructions, revision control, and change control processes.

Our Specialized Service Capabilities

  • Requirements assessment and definition. Qualification and selection of IaaS cloud vendor
  • Execution of cloud Qualification and produce all validation deliverables, reports as per GAMP v5 requirements along with implementation of a standard set of processes to support regulatory needs such as access management, physical data center controls, and clear definition of roles and responsibilities etc.
  • Documentation and reporting including: System design document, network diagrams, qualifications (IQ/OQ/PQ) for hardware, operating system, database, and applications
  • Security services:
    • Penetration Testing Service
    • File Integrity Monitoring Services
    • Database Security Risk Assessments
    • Database Security Services
    • Vulnerability Assessment Services
    • Managed Identity Services
  • Set-up of change management process and controls
  • Disaster recovery testing and platform audits

Our Services are designed to help customers efficiently achieve and maintain compliance with the required security and regulation standards in cloud deployments. We have many years of experience with ensuring regulatory compliance of cloud environments.

Whether you have to comply with regulatory requirements, or aim to meet or exceed Life sciences industry regulations and standards, Techsol has the skills, tools, and offerings to help you achieve the demanded security, integrity, and privacy levels and gain a competitive advantage.

Why Choose Us

Techsol has several years of experience helping customers efficiently achieve and maintain compliance with the required security and regulation standards with various Infra as a Service (IaaS) providers:

  • Oracle Cloud Infrastructure (OCI)
  • Amazon Web Services (AWS)
  • Salesforce cloud (SFDC)
  • Other IaaS, Co-Location and On-premise cloud infrastructure providers

Customers benefit from our services through:

  • Enablement of efficient and sustainable compliance with various required standards for cloud environments
  • Security and identity management according to required standards for managed environments
  • Seamless service management with periodic status reviews, comprehensive reporting, and proactive guidance
  • Reduced time and cost associated with achieving and maintaining compliance regulations in the cloud environments

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