Our Clients

Deliver quality software and be compliant. SQA applies a risk-based approach to balancing software quality with FDA systems validation and compliance.

Abbott

Alkermes

Applied Biosystems

Ariad

SQA consultants developed SOPs focused on Ariad’s IT Applications, Operations and Validation processes. As an integral part of the quality team, these consultants were highly involved with IT stakeholders to ensure compliance and uphold rigorous validation practices.

Focus

  • SOP Development
  • IT Applications
  • IT Operations
  • IT Validation

Bard

SQA performed a comprehensive evaluation of Bard’s QA organization. This included an examination of testing practices and organizational maturity, along with recommendations for future process improvement. Once implemented, these recommendations resulted in improved testing practices, defect-free product releases and continuous improvement opportunities in line with their organizational goals.

Focus

  • Lifecycle Optimization
  • Test Evaluation
  • Gap Analysis
  • Process Improvement
  • Risk Management
  • Skill Assessment

Bayer

Biogen

As a trusted validation partner, SQA developed test scripts, traceability matrices, validation documentation, standard operating procedures and training guides for Biogen’s ELN implementation.

Focus

  • Electronic Lab Notebook
  • NuGenesis
  • SciQuest
  • Workday

Boston Scientific

Boston Scientific leveraged SQA’s expertise to execute testing on a newly developed medical device. SQA ensured all testing complied with FDA standards.

Focus

  • Medical Device
  • Embedded Software
  • 3D Imaging
  • FDA Compliance

Cure Forward

SQA helped this start-up execute regression testing on custom patient portals built for the oncology community.

Focus

  • Device Testing
  • Defect Tracking
  • Web Portals
  • UAT

Daiichi Sankyo

DrugDev

SQA alleviated bandwidth challenges for this rapidly growing organization by writing & executing manual test scripts according to existing SOPs to maintain GxP standards.

Focus

  • SOPs
  • GxP
  • Clinical Trial Management

ERT

SQA designed, implemented and integrated a performance management discipline based on ITIL principles and enhanced testing capabilities. Additionally, SQA supported ERT’s functional automation team to develop a framework and create automated test scripts for medical device equipment.

Focus

  • SDLC
  • Python
  • Medical Device Testing
  • Selenium

IDEXX

SQA worked with Idexx to develop a 21 CFR Part 11 Compliance project plan. The team built a customized road map and supported the ongoing plan while implementing a laboratory information management system (LIMS).

Focus

  • UAT Test Execution
  • FDA Validation
  • LIMS

Ivenix

SQA optimized Ivenix’s product development processes, supporting the organization’s commitment to continuous software quality improvement.

Focus

  • Product Design Reviews
  • Process Improvement
  • Risk Management
  • FDA Compliance

m2s

SQA validated the quality and accuracy of data in twelve blinded data sets to ensure they met the specifications required by the Society for Vascular Surgery.

Focus

  • Validation Plan
  • Functional Systems Test
  • Data Quality Audit

Medtronic

NxStage

Parexel

Pfizer

Preventure

SQA supplied Preventure with software testing professionals to support the development of their flagship product. SQA hand-picked these resources to meet the organization’s culture and technical needs, allowing Preventure to respond to tight software delivery deadlines.

Focus

  • Web Applications
  • Mobile Device Testing
  • Salesforce

Roche Diagnostic

SQA collaborated with Roche Diagnostic, maker of the world’s first integrated hematology instrument, to support functional testing initiatives with a specific focus on defined quality management methodologies and metrics.

Focus

  • Integration Testing
  • Quality Systems Testing
  • FDA

Sunrise Labs

Joining this project mid-flight, SQA redefined business requirements, executed application testing and implemented automation practices to ensure quality products were delivered into the hands of customers in a competitive timeframe.

Focus

  • Medical Device (CRO)
  • Python
  • Embedded Software
  • Requirements Mgmt.

Vertex Pharmaceuticals

Waters

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