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.

TESTING ACROSS DEVICES

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

MOBILE

DESKTOP

WEB

VR DEVICES

WEARABLES

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Software Testing?

TESTING VERTICALS FROM A TO Z

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.

Technology

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

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Retail

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

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Healthcare

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

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Financials

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

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Biotech

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

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Insurance

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

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HOW WE DO IT

  • 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.

HOW IT WORKS

1

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

2

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

3

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

4

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

WHAT IT COSTS

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. Fill out a short form and our analyst will contact you.

TESTIMONIALS

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WHAT YOUR BENEFITS ARE?

  • 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.