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SQA SolutionHandbook: IT Validation, Quality, and Compliance for Clinical-Stage Pharma

SQA Solution Handbook: IT Validation, Quality, and Compliance for Clinical-Stage Pharma

A comprehensive guide to navigating GxP regulations, CSA, and global compliance strategies for modern clinical-stage life sciences companies.


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Are you responsible for IT compliance, validation, or quality oversight in a clinical-stage pharma or biotech environment?

This handbook is designed to support professionals like you — those working across QA, IT, Clinical Ops, and Regulatory — to implement risk-based, audit-ready validation programs.

It covers everything from foundational GxP expectations to implementing FDA’s Computer Software Assurance (CSA) methodology, integrating GAMP 5 best practices, managing vendors, overseeing change control, and building inspection-ready systems.

Whether you’re developing digital infrastructure or managing compliance for clinical manufacturing, this guide offers a practical and strategic framework.

Looking to Strengthen Your IT Validation and Compliance Strategy?

Download our in-depth handbook to master GxP regulations, apply CSA principles, and build audit-ready IT systems across your organization.

Download the Handbook (PDF)
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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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