CRO & Clinical Systems Validation

Validation built for clinical operations and CROs — EDC, CTMS, eTMF, IRT/RTSM and ePRO — under 21 CFR Part 11 and GCP, so your sponsor audits and inspections hold up.


Systems

Clinical systems we validate

We validate the platforms your studies run on, with sponsor- and inspector-ready evidence.

EDC

Electronic data capture — build, configuration and edit-check validation, with audit-trail and Part 11 controls.

CTMS

Clinical trial management — study, site and milestone tracking validated for data integrity.

eTMF

Electronic trial master file — completeness, access control and inspection-readiness.

IRT / RTSM

Randomization and trial supply management — the high-risk logic that needs the most assurance.

ePRO / eCOA

Patient-reported outcomes — device, data-flow and Part 11 validation.

Integrations

Validated data flows between clinical systems and downstream analytics.

Deliverables

What you receive

  • Validation plan aligned to GCP & Part 11
  • User requirements & configuration specs
  • Risk assessment focused on subject safety & data integrity
  • Edit-check and randomization test evidence
  • Audit-trail and e-signature verification
  • Vendor/SaaS qualification leverage
  • Traceability matrix (requirements → tests)
  • Audit-ready validation summary report

Built for sponsor audits. Evidence structured the way clinical QA and inspectors expect to see it — traceable, risk-based and defensible.

How it works

From protocol to validated, inspection-ready systems

STEP 01

Scope

Map systems, integrations and study risk.

STEP 02

Assess

Gap-assess configuration against GCP & Part 11.

STEP 03

Validate

Risk-based testing of high-impact functions first.

STEP 04

Sustain

Change control across amendments and releases.

Why SQA Solution

Why teams choose us

Clinical-specific, not generic CSV

We know EDC edit checks and RTSM logic — not just generic validation templates.

Sponsor & CRO ready

Evidence that satisfies sponsor oversight and CRO quality alike.

Current with 2026 guidance

Part 11, Annex 11 draft and the FDA CSA final guidance (Feb 2026).

Senior practitioners

Named consultants who can defend the work in an audit.

Fixed-fee, transparent scope

A defined engagement with a defined price and timeline — no open-ended hourly billing. Scope scales to your systems and goals.

Get a scoped quote

Validate the systems your studies depend on

Tell us which clinical platforms are in scope. We’ll come back with a fixed-fee plan and timeline.

Request a Quote
Some of our clients
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Case Studies
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SQA Solution's Approach to 21 CFR Part 11 Compliance in a Global Healthcare Corporation

A global healthcare corporation faced significant challenges in complying with 21 CFR Part 11, especially section 11.10

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    Strategic SOP Development for Enhanced Infrastructure and Compliance for BioPharma

    Developing comprehensive SOPs in a biopharmaceutical context is fundamental for ensuring regulatory compliance, and maintaining high standards of quality and safety …

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      Comprehensive API Testing for a Leading Credit Manager in Commercial Real Estate Lending

      Before engaging our services, the client faced significant challenges in ensuring the reliability, security, and overall quality of their API functionalities …

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        SAP S/4 HANA GxP Compliance and Validation Project

        The objective is to align the SAP S/4 HANA system of a leading biopharma
        company with the stringent requirements of GxP regulations and
        21 CFR Part 11 …

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          SQA Solution Quality Systems and Compliance Consultant at a Biotechnology Company

          The consultant’s role is pivotal in ensuring the compliance of computerized systems with regulatory standards and internal policies.

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            Optimizing Software Quality and Performance for a Leading Multi-Channel Retailer

            The retailer required a robust software infrastructure to ensure seamless online shopping experiences and operational efficiency …

              What Our Clients Say

              SQA Solution and I have partnered on several roles within our Engineering group over the last year. She has been incredibly supportive of our growth strategy and has presented candidates that we’re highly experienced and qualified. I like to say that Katherine never wastes our time. She is a skilled recruiter and has a great balance in working with and for both the company and candidate.

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              Beth-Anne Sama
              Head of People at Jupiter Intelligence SHRM-SCP

              Alina with SQA Solution was a fantastic recruiter! Alina was very responsive to my emails and provided consistent updates throughout the interview and on-boarding process with Roche. I am grateful for Alina’s guidance and it is thanks to her that I am now a Project Coordinator for Roche Molecular Solutions. I would recommend anyone looking for a job to contact Alina!

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              Garrett Tom
              Project Manager II, PMO - Roche Molecular Solutions

              My favorite thing about Stan is that he is a great person, as well as a highly-skilled recruiter. So many other staffing agencies that I had contacted really made me feel like I was a handful of cooked spaghetti (a job seeker) to be thrown at the nearest wall (job req) they had around. I never got that impression from Stan.

              So of course he’s intelligent, and resourceful, and very savvy about the art of getting a candidate hired. He’s also creative, and enthusiastic, and he enjoys a good laugh. I respect his talents, and he’s likeable too. That’s an impressive combination!

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              Kimberly Dolim
              Research Scientist in Molecular Biology

              It is my pleasure to recommend Julia and SQA Solution as I’ve had the pleasure of partnering with her over the past on a variety of difference IT related contract/CTH opportunities. During her time with SQA Julia’s ability to juggle multiple job orders is refreshing and has made a dramatic difference in the productivity level of our partnership. She has the patience, organization and the ability to determine the job seekers needs as well as a client’s needs. She provided excellent customer service and also understood my background and gave me the opportunity to work with her. I wish her much success now and in the future

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              Lakhan Rajput
              Director/Co Founder at Skill Bird
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