eQMS Validation

Validation for electronic quality management systems — Veeva Vault QMS, MasterControl and others — configured to your processes and validated to Part 11, Annex 11 and CSA expectations.


Scope

What we validate

Your eQMS is where quality lives — we validate the configuration, workflows and integrations that run it.

Document & change control

Controlled documents, change control and revision workflows validated end to end.

CAPA & deviations

The investigation and corrective-action workflows inspectors scrutinize.

Training records

Validated training-record management tied to controlled documents.

Part 11 controls

E-signatures, audit trails and access controls verified.

Integrations

Validated data flows to and from connected systems.

Periodic review

Keeping the validated state in control through upgrades and releases.

Deliverables

What you receive

  • Configuration-specific validation plan
  • User requirements & configuration specs
  • Risk-based test protocols
  • Audit-trail and e-signature verification
  • Vendor evidence leveraged under CSA
  • Traceability matrix
  • Release and upgrade change control
  • Audit-ready validation summary report

Risk-based, vendor-leveraged. Under CSA we lean on qualified vendor evidence and focus testing on your configuration and high-risk workflows — faster, and defensible.

How it works

A validated eQMS that stays validated

STEP 01

Scope

Map configuration, workflows and integrations.

STEP 02

Assess

Leverage vendor evidence; target the gaps.

STEP 03

Validate

Risk-based testing of critical workflows.

STEP 04

Sustain

Periodic review and upgrade change control.

Why SQA Solution

Why teams choose us

Platform-aware

We know how Veeva and MasterControl actually behave — not a generic checklist.

CSA-efficient

Vendor-leveraged assurance that avoids redundant testing.

Current with 2026 guidance

Part 11, Annex 11 draft and FDA CSA final guidance.

Senior practitioners

Defensible work from named consultants.

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 your eQMS the efficient, defensible way

Tell us your platform and configuration. We’ll scope a fixed-fee validation.

Request a Quote
Some of our clients
client client client client client client client
Case Studies
image
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

    image
    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 …

      image
      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 …

        image
        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 …

          image
          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.

            image
            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.

              user photo
              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!

              user photo
              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!

              user photo
              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

              user photo
              Lakhan Rajput
              Director/Co Founder at Skill Bird
              Seeking Top-Tier Talent?
              Let's Discuss Your Project!