Computer System Validation Solutions

Our SQA Solution Computer System Validation team can work with your company in testing and validation, regulatory compliance, and audits. We service leading pharmaceutical, biotech, and medical device companies.

Our SQA Solution Computer System Validation team can work with your company in testing and validation, regulatory compliance, and audits. We service leading pharmaceutical, biotech, and medical device companies.

We customize our Computer System Validation services to handle your needs. We can deliver a project, augment your staff, manage services onsite, or manage them through our onshore or offshore capacities.

Our Computer System Validation Team provides value by bringing a strategic balance of industry experience, technical skills, and best practices to the engagement. We succeed by integrating our expert services with your company culture and procedures.

SQA Solution understands the necessity for validating regulated systems in a cost-effective manner, doing so correctly, and complying with specified rules and regulations. In the life science industry, software and systems that perform GxP related functions need to be verified. Computerized systems can include the following: control systems, automated manufacturing equipment, laboratory data capture systems, automated laboratory equipment, computers running the laboratory, manufacturing execution systems, manufacturing or clinical database systems, and any interfaces to other GxP systems. If one or more of these systems runs your operations, SQA Solution offers a complete range of services for your computer validation needs.

Testing and Validation Services

If your company is regulated by the FDA or other agencies, we offer a complete range of testing and validation services within the life sciences arena. This encompasses computer systems validation (CSV), testing of non-regulated and regulated equipment, systems, facilities qualification, and regulatory compliance. Our testing and validation includes GxP, PDMA, 21 CFR Part 11, Sarbanes-Oxley (SOX), and so on. Our expert team has all the necessary training in FDA regulations, other industry regulations, and best practices, such as risk-based methodologies.

Furthermore, we support your quality, compliance, and operational goals on engagements with the following activities: requirements definition and traceability, risk assessment and risk mitigation, validation planning, internal and external vendor audits, SOP development, test script and test plan development and execution, validation summarization, deployment, and continuing validation maintenance.

Depending on your needs, we can take on a leadership role and manage the entire validation project following our quality program with scheduled deliverables and staffed with our consultants. Alternatively, we can provide consultants to join your team at your site who will adhere to your own quality program.

SQA Solution’s Validation Services

Our computerized systems and software validation services include the following:

  • Building Management Systems (BMS)
  • Process Control Systems (PCS)
  • Laboratory Instrument Software
  • Laboratory Information Management System (LIMS)
  • Enterprise Resource Planning (ERP)
  • Electronic Document Management Systems (EDMS)
  • Corrective and Preventive Action Systems (CAPA)

Value-Added Validation

Validating Computerized Systems makes sure that an automated system is suitable for its designed use. Too many validation endeavors lead to tons of documentation without satisfying the goal of validation. SQA Solution’s validation methodology makes sure that customized and configured portions of the application are diligently validated. The end result will be a well-functioning program that is sure to please any inspector.

TrackWise Validation

SQA Solution specializes in efficient, cost-effective TrackWise validation.

21 CFR Part 11

21 CFR Part 11 is complicated and non-negotiable. At SQA Solution, we have the knowledge and expertise to help your organization in its effort to develop a well-established plan. We will help you to implement and validate this plan and bring your company into compliance.

Regulatory Compliance Services

SQA Solution has years of experience providing regulatory compliance services. These include performing audits, qualifications, validation, and managing documentation.

Our previous CSV engagements have included:

  • Quality Assurance review and analysis of project documentation deliverables.
  • Regulatory Compliance and Risk Assessments, including for GLP, GCP, GMP, SOX, 21 CFR Part 11, and PDMA.
  • Independent internal and external vendor audits, both GxP and IT.
  • Development of Standardized Regulatory Practices and Processes.


From mobile to web and beyond, SQA Solution has you covered.




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SQA Solution serves companies from a variety of industries from Retail to Media to Travel and more. Learn more about how we can help companies in your industry by selecting one below.


Healthcare, Dental, Life or Auto Insurance. Insurance exchanges and aggregators

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Software Validation, HIPAA Compliance, 21 CFR Part 11, 13. , GMP, GLP Trainings, CAPA Validation, Software Development, Security and Compliance

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Specialists in the Retail industry with the following knowledge: CMS, Big Data Hadoop, Distributed Systems, Cloud Infrastructure, SEO, SEM

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We deliver qualified engineering and IT candidates to small or large companies in technology sector

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Financial Institutions, FinTech, Accounting Firms, Stock Exchanges, Government Organizations, Forecasting Software

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Pharmaceuticals, Medical Devices, BioTechnologies, DNA Analysis and Sequencing, Software Validation

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  • Your app needs to work where your users live, work and play and that’s exactly where our testers are.
  • SQA Solution puts your app through rigorous testing using professional testers on real devices across locations and use cases that match your actual users.
  • Your custom testing team and QA Project Manager are the winning combination to reduce overhead and maximize app quality.



Fill out a short form with project details, e.g., brief description of requirements, testing needs and/or specific instructions


Our QA Project Manager will get in touch with you over the phone or by email to clarify the details: the number of FTEs or QA specialists, deadlines, test plan etc


We prepare a Teaming Agreement. Access to an extensive resources pool allows to quickly build a testing team of any size for any client


Your software is put through rigorous testing and quality checking on real devices. All test scenarios are tailored to suit any requirements and will match your end users behavior
We provide you with a detailed bug report. Following internal SQA methodologies, only the worlds best industry practices, testing techniques, and testing tools are used, ensuring accurate testing results


Pricing starts as low as $25 per testing hour

Pricing starts as low as $25 per testing hour

Getting started with SQA Solution is more affordable than you may think.
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SQA Solution has been helping Vertical Response in finding the right talent in the last couple of years. As a hiring manager I admire the folks at SQA Solution for their abilities to effectively pre-screen candidates so myself and other hiring managers are not wasting time interviewing candidates that do not have essential skills for the job. Both recruiters and account managers are always available for discussions, transparent and honest. They set an example of what Staffing company should be like...
Alex Teymur (Sr. QA Manager)

PROS What I like about SQA Solution that is their support. They will never discourage you in any way. I was able to come back to repeat the course after 2 years because I was busy with a baby. Last time the teacher was Prashant and Lesya. I can't say anything bad about them. Practically there is the same fast pace with JF now. I would say even much faster and much more info now. I even fell easily behind this time. But JF is very knowledgeable and responsive, he understands that every person is different. Now they are finally record their sessions which is a HUGE plus. The only complain I would say that he needs to make more breaks (like 5 minutes) and separate home tasks from class exercises. Also they renewed their website where described their curriculum in more details. Check it out sqasolution.comCONS Please do not expect miracles.
Olga (Previous Student)

SQA Solution On Demand Testing model allowed our start up to save a dramatic cost on having to hire additional resources that we may not have needed after our major release was over. The awesomeness is that you can use these guys for 6 or 60 hours a week, they are always there for you. Professional management and smart engineers!!
Armen Gasanyan (CTO Delivery Guys)

I started out with SQA Solution in August to learn Selenium WebDriver using Java. In a short period of time, instructor was able to teach me Java, Selenium WebDriver, Junit and provided many tips on how to build a test automation framework with all the bells and whistles, including wait logic and more. He also prepared me for the interview for an Automated QA Engineer position. The classes are very organized and tailored to your needs. So if you don't know anything, or maybe know something and are looking to improve your skills in test automation, then he will setup the class structure according to your needs. The great thing about the class is has small groups just a one-on-one session and you get to ask all the questions and you have his full attention, which is great!!! They explains everything in detail and you get to work on a project with them. I strongly recommend their courses for anyone looking to learn automation testing from scratch or improve their skills. It is also very affordable compared to other test automation courses in the area.Excellent teaching skills. covered all parts of the course in a concise manner. very nicely presented PPT slides for quick refresher guide In class demos are the highlights of the classes. People should enroll to get trained on all the latest testing techniques
Scott (Previous Student)

It was the best 6 weeks I have spent in my spare time! Even though I have a computer science background, it was hard for me to start looking things online and brushing my skills on my own. We have started learning with baby steps from downloading/configuring Eclipse and writing a "Hello World!" Project in Java language. Instructors are super patient, intelligent professionals and well versatile in their domain. In 6 weeks, we have not only covered Java OOP language, but also JUnit, TestNg, Maven, gitHub, UNIX, CSS, Xpath, Selenium IDE, RC, Web Driver tools. Classes are only limited to 8 people and there is an option to join the course in person or online. Weekly 20 hours in 6 weeks period, you get to know great people and learn more by helping each other. I have gained great knowledge and would recommend everybody who is planning improve automation test engineer skills.


  • Save time by mitigating all negative effects before they reach your customers.
  • Get product faster-to-market by opting for strategic QA planning, expert QA consulting and top-notch testing services.
  • Save resources and reduce overhead with a dedicated SQA team and QA Project Manager.
  • Be competitive by releasing products on time, with assured quality, reliability, performance, and security.
  • Work directly with a personal QA project manager, who will lead your project through all stages.
  • Proactive and quick services – get the first results within just 24 hours after signing the contract.
  • Receive subsequent 24/7 top-notch support and QA consulting services.