LMBlue Technologies
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Pharma/Biotech
Corporate Services
Contact Us
LMBlue Technologies
Home
Pharma/Biotech
Corporate Services
Contact Us
More
  • Home
  • Pharma/Biotech
  • Corporate Services
  • Contact Us
  • Home
  • Pharma/Biotech
  • Corporate Services
  • Contact Us

Pharma/Biotech Services

Quality Compliance Services

  • Quality Management System (QMS), assessment, development and optimization
  • QMS gap analysis for compliance against global regulations and standards (US FDA, ICH, EU, WHO, NMPA, Health Canada, ISO 9001, ISO 17025)
  • GxP Training for all levels of staff
  • Deviation/OOS management, investigations and Corrective and Preventative Actions (CAPA)
  • Risk assessment and management
  • Vendor selection and maintenance including planning and execution of quality audits (ability to travel within and outside US)

Information Technology Services

  • IT system architecture and security strategy assessment and planning
  • Compliance-readiness risk assessments, gap analysis and remediation planning 
  • Cloud-based system development and maintenance 
  • Cloud & data migration services
  • Digital technology integration
  • 21CFR Part 11 compliance-readiness preparation
  • Backup and disaster recovery
  • Sarbanes Oxley (SOX) compliance assessment and audit preparation
  • Payment Card Industry Data Security Standard (PCI DSS) compliance services
  • 2nd Opinions and Verification Services

Custom Validation Services

 Let us build a custom validation package for your LIMS-based software system that can benefit you and your clients. We specialize in partnering with LIMS-based software developers to create comprehensive validation packages tailored to their systems. Our expertise ensures that both your software and your clients’ implementations meet regulatory requirements with precision and efficiency.


We offer a unique tiered-incentive package to collaborate with you and your clients, enabling seamless integration and validation processes while maximizing your full potential. Our team is dedicated to helping you enhance compliance, improve operational efficiency, and build trust with your clients by delivering high-quality validation solutions.

Get in Touch

Interested in learning more about our services? Contact us today to schedule a consultation with one of our experts.

Contact Us

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