How xLM Facilitated meshMD's Transition to AWS with GxP Compliance

meshMD, a prominent SaaS provider for pharmaceutical companies in Canada, faced a significant challenge when one of their data center providers announced its impending shutdown. They needed to migrate their GxP-regulated assets to AWS while adhering to stringent industry regulations. With a tight four-week deadline, they sought xLM's expertise for a seamless validation and qualification solution.

The Challenge: Navigating a Tight Compliance Deadline

Although meshMD had structured their transition plan, they required an expert partner to validate and qualify their AWS environment within an exceptionally tight timeframe. The complexity of the migration extended beyond mere data transfer; it involved ensuring ongoing compliance within a highly regulated industry. With no room for error, they needed a reliable validation partner to execute the task effectively.

xLM’s Continuous GxP-Compliant Qualification Solution

At xLM, we promptly engaged with meshMD’s technical team to clarify the intended use of AWS’s IaaS and PaaS services. Our experts crafted a robust qualification plan and delivered a comprehensive continuous qualification package that fulfilled all GxP, HIPAA, and privacy compliance requirements—well within the four-week deadline.

AWS Services Validated by xLM for meshMD

As part of the qualification process, xLM validated and continues to manage the following AWS services for meshMD:

  • S3 – Secure and compliant storage for regulated data
  • Security – Ensuring AWS security configurations align with GxP and HIPAA standards
  • EC2 – Qualification of virtual compute environments
  • VPC – Validation of virtual private cloud infrastructure
  • Elastic IP – Ensuring secure, static IP configurations
  • CloudWatch – Monitoring and logging for compliance and system integrity
  • KMS – Managing encryption keys for data security
  • RDS – Qualification of relational database services for regulated data

Ongoing Compliance with xLM’s Continuous Qualification

Meeting the initial qualification deadline was just the beginning. xLM has taken the initiative in managing the qualification of meshMD’s AWS services, providing ongoing validation to ensure that compliance is consistently maintained. Through our continuous qualification strategy, meshMD can confidently serve its pharmaceutical clients without regulatory concerns.

Key Challenges & Solutions

The Challenges:

  • Complex Data Migration: meshMD needed to transition data from various brick-and-mortar providers to AWS.
  • Strict Compliance Requirements: Their AWS infrastructure had to satisfy stringent GxP, HIPAA, and privacy regulations.
  • Limited Timeframe: The entire qualification process had to be completed within just four weeks.

The xLM Solution:

  • Collaborative Approach: xLM partnered closely with meshMD to define AWS service usage.
  • Efficient Qualification Process: Our team developed a structured qualification plan and executed a fully compliant continuous qualification package.
  • Ongoing Compliance Management: xLM continues to oversee AWS qualifications for meshMD, ensuring sustained regulatory adherence.

With xLM’s expertise and continuous qualification framework, meshMD successfully transitioned to AWS while upholding the highest compliance standards. Our partnership guarantees they remain audit-ready and compliant in a rapidly evolving regulatory landscape.