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QUALITY OVERSIGHT AND TRAINING KEEPS TRIALS ON TRACK.

From QMS to validation, audits, and training, we deliver the systems and skills your trial needs for inspection ready compliance and efficient execution.

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EXPECT QA RESULTS

At Biorasi, quality is more than a deliverable — it’s a shared commitment.

From comprehensive solutions to standalone programs, our QA team integrates seamlessly with your operations, acting as an extension of your team from day one.

Biorasi safeguards ICH GCP compliance, study participant protection, and data integrity using proportionality and risk to meet your stakeholders’ goals.

Whether you need a complete quality management system, expert validation oversight, or targeted training, we help you navigate milestones with confidence and clarity.

Our approach is risk-based and proactive, strengthening competencies across your team and keeping studies inspection ready. We measure success by the outcomes we achieve together.

Quality

 

QA WHERE IT MATTERS MOST

  • ICH GCP–required activities without the burden of building or staffing an in-house department
  • Integrated Approach – Cross-functional alignment with clinical, data, and regulatory teams
  • Flexible support that adapts to your specific study needs
  • Access to experienced QA leaders who understand the operational realities of your trial

 

BIORASI QA SOLUTIONS

QUALITY MANAGEMENT
SYSTEM (OMS)

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  • Develop and maintain procedure portfolios (Policies, SOPs, WIs, templates) aligned to ICH GCP, ISO 9001, and ISO 13485
  • Authoring, review, and revision support; creation of document template types
  • QMS setup and implementation; project management services

VALIDATION (CSV, SAMD)

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  • CSV and SaMD (C1 & C2), SDLC support, computer system validation, and change control
  • Sponsor-focused procedures and templates; Biorasi provides oversight, compliance review, and execution support while you retain approval authority

DECENTRALIZED CLINICAL
TECHNOLOGIES (DCT)

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  • Compliance and issue management
  • Review of product releases and patches for risk; support in coordinating with DCT vendors

AUDITS

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  • Vendor and internal audits; initial and current vendor qualification; audits of sponsor functions
  • Clear, actionable audit reports; scopes defined collaboratively with your priorities in mind

VENDOR QUALIFICATION

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  • Qualification / requalification of vendors and GCP system providers
  • Vendor Management Program development:
    • questionnaires
    • documentation of qualification
    • audits per agreed procedures

TRAINING (LEARNING &
DEVELOPMENT)

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  • Building and delivering training such as: GCP, Security Essentials, Privacy; CAPA & Root Cause Analysis; SOP comprehension (incl. exams); Lean Six Sigma & Risk Management
  • We offer a variety of formats ranging from handouts, presentations, and interactive web-based courses tailored for your team’s learning style and timelines
Quality Performance

 

ARE THESE ON YOUR MIND?

  • How strong is your current QA / Validation / L&D team?
  • Which parts of your QMS need reinforcement?
  • When was your eTMF last validated?
  • Are your policies and templates serving you well?
  • Is your custom-built software fully validated?
  • Are you ready for your next audit or inspection?

 

OUR TEAM COMMITMENT

ONE TEAM – ONE PARTNERSHIP

Our QA, Validation, and L&D specialists work shoulder-to-shoulder with your teams, embedding quality into daily operations rather than bolting it on at the end.

COLLABORATIVE OVERSIGHT

From SOP development to vendor audits, each offering is designed for your organization — practical, compliant, and aligned to your company’s needs for seamless implementation into your operations. Real-time tracking and open communication keep everyone informed and moving forward.

THE BIORASI ADVANTAGE

Reliability

Reliability

Proven processes and joint accountability for quality and compliance

 

Flexibility

Flexibility

Services tailored to your operational model
and changing needs

Accessibility

Accessibility

Direct access to senior QA leadership and transparent reporting dashboards

 

FROM OUR PARTNERS