LIMS, MES & Manufacturing Systems Validation

Validation for the systems that run your labs and production floor — LIMS, MES, SCADA, chromatography data systems and instrument software — risk-based, Part 11-compliant and inspection-ready.


Systems

What we validate

From sample login to batch release, we validate the GxP systems your operations depend on.

LIMS

Laboratory information management — sample, result and specification workflows validated for integrity.

MES

Manufacturing execution — electronic batch records and production workflows.

CDS

Chromatography data systems — the classic data-integrity hotspot, validated and controlled.

SCADA / control

Supervisory control and data acquisition for regulated processes.

Instrument software

Qualified instrument systems and their data handling.

Integrations

Validated flows between lab, manufacturing and quality systems.

Deliverables

What you receive

  • System-specific validation plan
  • User & functional requirements
  • Risk-based IQ/OQ/PQ protocols
  • Data-integrity (ALCOA++) evidence
  • Audit-trail and access-control verification
  • Vendor qualification leverage
  • Traceability matrix
  • Audit-ready validation summary report

Where data integrity is won or lost. Lab and manufacturing systems are the most-cited DI areas — we validate them with that scrutiny in mind.

How it works

Validated operations, end to end

STEP 01

Scope

Inventory systems, instruments and integrations.

STEP 02

Assess

Risk-classify and leverage vendor evidence.

STEP 03

Validate

IQ/OQ/PQ focused on high-risk functions.

STEP 04

Sustain

Requalification and change control.

Why SQA Solution

Why teams choose us

Operations fluency

We understand CDS, LIMS and MES behavior — not just validation theory.

Data-integrity first

The areas inspectors cite most are where we focus.

CSA-efficient

Risk-based testing, vendor-leveraged where justified.

Senior, defensible

Named consultants behind every deliverable.

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 lab and manufacturing systems

Tell us which systems are in scope. We’ll scope a fixed-fee validation plan.

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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