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SQA SolutionOn Demand TestingComputer System Validation (CSV)

Computer System Validation (CSV)

At SQA Solution, our Computer System Validation team specializes in offering premier testing, validation, and regulatory compliance services. We proudly serve leading pharmaceutical, biotech, and medical device companies, ensuring adherence to FDA and global regulatory standards.


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SQA Solution: The Gold Standard in Validation Services

In the dynamic world of regulatory compliance, SQA Solution stands out as a beacon of excellence. Rooted in the heart of innovation, we bring unmatched expertise, particularly in the pharmaceutical, biotechnology, and medical device sectors.

Our Validation Services

Our holistic approach extends beyond mere validation. We offer a spectrum of services, including program validation, development, project management, and specialized training programs, ensuring you’re always audit-ready and compliant with international standards.

Explore a spectrum of services tailored to meet your specific needs:

  • Regulatory Compliance: We navigate the intricacies of FDA regulations, GxP compliance, and international standards like 21 CFR Part 11, EU Annex 11, and GAMP 5. From system audits and IT vendor audits to data privacy and cybersecurity services, we ensure that your organization adheres to regulatory standards.
  • Data Integrity and Security: Upholding the integrity and security of your data is paramount to us. We employ rigorous data integrity assessments and advanced security measures.
  • Risk Reduction: Our risk-based approach, aligned with GAMP5 and other international guidelines, empowers us to effectively identify and mitigate potential risks.
  • Enhanced Software Performance: Through performance testing and validation, we enhance the stability, functionality, and responsiveness of your software.
  • Digital Innovation Services: Harness the power of emerging technologies like robotics, AI, and machine learning for innovative business solutions and seamless cloud migration, ensuring your business stays at the forefront of technological advancements.
  • Audits: Our comprehensive audits, including IT vendor audits and software validation & data integrity audits, prepare your organization for compliance and excellence
  • Software & Systems: From Excel Spreadsheet Validation to ERP, QMS, LIMS, Veeva, SAP, and other GXP software, we’ve got you covered.
  • Clinical Systems: Our expertise spans EDC systems like Medidata Rave and Oracle’s InForm, eTMF systems such as Veeva Vault, and CTMS systems including Veeva Vault CTMS.
  • Regulatory Compliance: Stay compliant with our Regulatory Information Management (RIM) solutions, including the renowned Vault RIM Suite from Veeva Systems.
  • End-to-End Validation Services: Our end-to-end validation services encompass everything from commissioning and qualification of laboratory equipment to comprehensive computer systems validation, ensuring every aspect of your operations meets the highest standards of regulatory compliance.
  • Adherence to Quality: Our unwavering adherence to industry standards like ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR underscores our commitment to delivering unmatched quality and compliance in all our services.
  • Collaborative Partnership: As your trusted partner, we collaborate closely with your team throughout the validation process. Our experts listen to your specific requirements, understand your systems, and deliver tailor-made validation solutions that align with your organization’s needs.

Benefits of Our Validation Services

  • cGMP Compliance: Our services ensure that your systems adhere to current Good Manufacturing Practices, ensuring product quality and safety.
  • Regulatory Compliance: Stay ahead of regulatory changes and ensure your systems are always compliant.
  • Data Integrity: Ensure that your data remains accurate, consistent, and reliable throughout its lifecycle.
  • Risk Mitigation: Identify potential risks early and implement measures to mitigate them.

Industries Served

  • Pharmaceuticals: Ensure drug safety and efficacy with our comprehensive validation services.
  • Biotechnology: Stay compliant with biotech regulations and ensure product quality.
  • Medical Devices: Ensure your medical devices meet all regulatory standards and are safe for use.

Efficiency Meets Excellence

Our solutions are meticulously crafted, leveraging cutting-edge technology to streamline the validation process, ensuring faster and cost-effective validations that adhere to global compliance standards.

Maximizing Your Operational Performance

At SQA Solution, we believe in the power of synergy. Our comprehensive suite of validation services is designed to enhance and optimize your operational performance, driving efficiency, profitability, and sustainable growth.

Global Expertise, Tailored Solutions

With a robust global presence and strategic partnerships, we deliver bespoke solutions that resonate with the diverse needs of businesses worldwide, from startups to global conglomerates.

FAQs

  1. What is Computer System Validation (CSV)?
    CSV ensures that computer systems operate correctly and produce results that are consistent with their intended use.
  2. Why is regulatory compliance important in validation services?
    Regulatory compliance ensures that products meet safety and quality standards, protecting both businesses and consumers.
  3. How does SQA Solution ensure data integrity in validation services?
    We employ rigorous data integrity assessments and advanced security measures to ensure data remains accurate and reliable.
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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      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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      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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      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.

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      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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