Cloud Assurance for Life Sciences Compliance

SQA Solution’s Cloud Assurance Service provides the continuous compliance and validation your life sciences business needs to stay ahead of regulatory changes and industry standards. We combine cutting-edge automation, industry-specific expertise, and personalized service to offload your compliance burden and ensure you remain audit-ready.


Request a Quote

In today’s fast-paced world of life sciences, regulatory compliance is no longer optional – it’s a critical foundation for ensuring the safety, efficacy, and privacy of your products and data. With cloud systems becoming integral to innovation, it is paramount to ensure that your cloud applications and infrastructure remain in compliance with GxP, HIPAA, and SOC 2 regulations.

Why Choose SQA Solution Cloud Assurance?

Unlock Compliance Confidence

  • Always Compliant, Always Optimized: Stay continuously compliant with 21 CFR Part 11, EU Annex 11, HIPAA, and SOC 2 With our Cloud Assurance service, you’re always audit-ready.
  • Automation-Driven Compliance: Minimize manual oversight through automated testing, compliance monitoring, and continuous documentation generation.
  • Tailored for Life Sciences: Designed specifically for pharma, biotech, medical devices, and manufacturing. We understand your unique compliance needs.
  • Proven Track Record: Like leading providers in the industry, we provide industry-specific expertise, and have successfully worked with top pharma and biotech companies, ensuring that compliance is streamlined across complex cloud environments.

Key Features

  1. Continuous GxP Compliance & Validation
    SQA Solution’s platform ensures that your cloud systems remain in compliance with GxP, HIPAA, SOC 2, and more, without manual intervention. Every change is validated in real-time, ensuring your systems stay in a validated state around the clock.
  2. Full Compliance Scope
    • GxP (GLP, GCP, GMP) and 21 CFR Part 11
    • HIPAA and HITRUST for sensitive healthcare data
    • SOC 2 Type II for security and availability
    • ISO 27001, GDPR, and more
  3. Cloud Validation Automation
    Automate the validation process with regression test suites and automated compliance scans that run after every update to your cloud applications or infrastructure. We provide real-time compliance status updates and automatic remediation for non-compliance issues.
  4. Data Integrity & Security
    Our Policy-as-Code model continuously monitors and enforces security policies and controls to safeguard patient and business data.
  5. Seamless Integration
    Integrate with your existing cloud platforms, including AWS, Azure, GCP, and Veeva, to continuously ensure compliance without the hassle of re-validation after every change.

Service Models

Managed Service Subscription
SQA Solution offers a flexible, subscription-based model for Cloud Assurance. You can choose a plan that fits your organization’s needs:

  • Custom Packages: Tailor your service to fit specific regulatory needs.
  • Predictable Pricing: Our transparent pricing ensures you know what to expect without hidden fees.

Co-Managed Approach
For enterprises that want control over their cloud environments, our co-managed service provides you with the ability to retain oversight of your systems while we ensure continuous compliance.

Pricing

Cost-Effective Compliance
With SQA Solution’s Cloud Assurance, you receive high-quality compliance services that offer significant cost savings over traditional, manual compliance processes. We provide competitive and scalable pricing designed to meet the needs of companies both large and small.

  • Basic Package: Ideal for small biotech and startups.
  • Enterprise Package: Designed for global pharma and biotech companies requiring large-scale, multi-cloud compliance solutions.

Request a Quote
For detailed pricing, please contact us and schedule a consultation to discuss your specific needs.

Why SQA Solution?

  1. Deep Life Sciences Expertise
    Our team brings decades of experience in the life sciences sector, specifically in pharma, biotech, medical devices, and manufacturing. Our compliance experts understand the intricacies of regulatory requirements and know how to navigate complex compliance landscapes.
  2. Transparent, Hands-On Support
    Unlike other providers that rely on ticketing systems or long response times, SQA Solution offers direct, hands-on support. You’ll have access to our team 24/7 for audit support, troubleshooting, and compliance advice.
  3. Proven Automation
    Our platform uses state-of-the-art tools for automating compliance tests and continuous monitoring, ensuring that your cloud environment stays compliant without the burden of manual oversight.
  4. Audit-Ready, All the Time
    With our continuous validation, you can focus on innovation while we ensure that your systems remain ready for FDA audits, EMA inspections, and client audits at all times.

Get Started Today

Contact SQA Solution to schedule a demo or consultation.
Our experts will assess your current systems and create a customized plan to ensure compliance with GxP, HIPAA, SOC 2, and all applicable regulatory standards.

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 Testing Talent?
              Let's Discuss Your Project!