When it comes to GxP compliance, speed and precision are non-negotiable.

100%

Compliance with GxP, HIPAA, and privacy regulations

4 weeks

Successful migration completed on time

0%

Downtime during transition

8

AWS services validated and continuously monitored

The Challenge

meshMD faced several urgent challenges:

  • Tight Deadline: Only four weeks to qualify their new AWS infrastructure to meet GxP compliance.
  • Critical Systems Migration: Needed to transition GxP-regulated assets from multiple data centers without disrupting operations.
  • Strict Regulations: As a provider to major pharmaceutical companies, meshMD’s AWS environment had to comply with GxP, HIPAA, and privacy standards.
  • Compliance Risk: Failure to validate in time could jeopardize their ability to serve regulated customers and remain audit-ready.

The Solution

xLM implemented its framework tailored for AWS, ensuring rapid qualification and ongoing compliance.

Key actions included:

  • Partnered closely with meshMD to define intended use for all IaaS and PaaS services.
  • Delivered a fully GxP-compliant qualification package within just four weeks.
  • Established continuous validation processes to manage ongoing AWS compliance.

The Result

The collaboration with xLM delivered measurable success for meshMD:

  • On-Time Migration: Seamless transition to AWS with zero disruption.
  • Full Compliance: Achieved validation for GxP, HIPAA, and privacy requirements.
  • Scalable SaaS Delivery: With compliance assured, meshMD continues to deliver secure SaaS solutions to leading pharmaceutical clients in Canada.
  • Trusted Expertise: meshMD could focus on operations while relying on xLM’s regulatory validation expertise.

Services Provided

  • AWS Cloud Qualification
  • Software Validation
  • Validation Planning
  • Regulatory Compliance