On-Site quality assistance

At AETHER, we understand that engineering organizations need robust quality systems that support innovation while ensuring regulatory compliance. Our specialized quality consultants deliver end-to-end solutions tailored to your unique challenges.

"Quality means doing it right when no one is looking." - Henri Ford

Quality Assurance, Validation & Control Services

Process Validation & Lifecycle Quality Assurance

  • Process Validation – Define and execute validation protocols for manufacturing processes.
  • Process Validation Analysis – Review test results, perform statistical analysis, and document findings in validation reports.
  • Process Validation Follow-up – Ensure processes remain in a validated state, perform periodic requalification, and implement improvements based on deviations or change control.
  • Validation Documentation – Document validation activities in compliance with regulatory and quality requirements.
  • QA Project Lifecycle – Provide technical guidance on quality requirements throughout project lifecycles.

Quality Control

  • Define QC Methods – Define and maintain product specifications with standard quality testing methods.
  • QC Tests – Perform analytical and physical testing on incoming materials, intermediates, and finished products: Dimensional & Visual, Functional, NDT (Non-Destructive), Chemical/Analytical, Electrical, Software, Environmental/Stress.
  • QC Equipment Calibration – Maintain calibrated quality control equipment to ensure measurement accuracy.
  • QC Laboratories – Use accredited external laboratories for specialized or regulated QC tests.
  • QC Reports – Prepare clear QC reports detailing methods, results, deviations, and conclusions.
  • Product QC Before Release – Ensure product conformity to quality specifications before release.
Write your awesome label here.
Write your awesome label here.

Customer, Stakeholder & Training Management

  • Customer Complaints – Manage customer complaints and coordinate resolution.
  • QA Stakeholders Interface – Act as the quality interface for internal and external stakeholders, supporting project managers.
  • Subcontractor Qualification – Support qualification and performance monitoring of subcontractors.
  • Quality System Training – Deliver training on ISO/GMP and quality best practices.
  • Operational Quality Training Creation – Develop and deliver training materials on operational quality practices.
“"Quality means doing it right when no one is looking."
Henry Ford

Compliance & Audit Management

  • Unannounced Inspection Readiness – Maintain readiness for unannounced inspections by implementing procedures, records, and controls that demonstrate compliance at any moment.
  • Quality Audits – Plan and conduct internal and external customer, project, and product quality assurance audits to verify conformance to standards and client requirements.
  • Regulatory Monitoring – Continuously monitor regulatory changes, assess operational impact, and coordinate necessary adaptations.
  • Standards Conformity – Ensure conformity with ISO, GMP, CE, or other sector-specific standards by aligning processes and documentation.
  • Regulatory Liaison – Act as liaison with regulatory bodies and certification authorities to manage inspections, certifications, and approvals.
  • Standards to Procedures – Translate standard requirements into practical, actionable procedures for the organization.

CAPA Deficiencies Are a Top FDA Observation in MedTech

During FDA inspections, CAPA system deficiencies are among the most frequent Form 483 observations in the medical technology sector. The most common gaps include:
  • Missing or incomplete documented CAPA procedures
  • Superficial root cause investigations
  • No effective verification of action effectiveness

The 1-10-100 Quality Rule Applied to CAPA

In life sciences quality management, it’s established that $1 spent on prevention equals $10 for product control and $100 for correcting a product failure. A well-designed CAPA system—especially preventive actions—delivers far higher ROI than corrective fixes after an incident.

Corrective & Preventive Action (CAPA) Systems

  • QA Deviation Detection – Inspect products and processes to detect deviations from standards and document audit findings.
  • QC Deviation Investigation – Investigate out-of-specification results from QC tests and coordinate resolution.
  • CAPA Implementation – Implement CAPA and risk management systems to address non-conformities and prevent recurrence.
  • CAPA Investigation – Investigate quality issues, identify root causes, and implement corrective/preventive actions.
  • CAPA Tracking – Track and verify the effectiveness of corrective measures over time.

Continuous Improvement & Quality Leadership

  • Culture of Continuous Quality Improvement – Promote and embed a culture of quality continuous improvement across the organization.
  • QA Lessons Learned – Facilitate lessons learned and best practice sharing across teams.
  • QMS Improvement – Drive QMS optimization for efficiency and compliance.
  • Quality Data Analysis – Analyze quality data to detect trends and improvement opportunities.
  • Operational Quality Guidance – Provide ongoing guidance to ensure awareness and compliance with operational quality.
  • Quality Improvement – Lead initiatives to enhance product quality and process efficiency.
  • QA Metrics – Track KPIs and quality metrics to drive performance.
  • QA Plans – Develop, document, and implement QA policies, procedures, and Quality Assurance Plans (QAP).
Created with