Healthcare & Life Sciences

Ensure Software Quality, Speed, Reliability, and Traceability for Health & Life Sciences Systems

TTC understands the Health and Life Sciences Industry's need for speed to market, while meeting multiple regulatory compliance requirements including 21 CFR Part 11, GxP Compliance, IEC 62304 and ISO 13485. This necessitates a Digital Transformation and Modernization of the Quality Management System allowing for new technologies and big data analytics while still meeting compliance in a rigorous regulatory landscape. TTC applies a risk-based approach to testing that allows organizations to become more efficient, innovative, and able to ensure security of patient data and compliance. TTC is a software QA testing partner who has domain expertise; a deep understanding of Part 11, IEC, ISO; and the importance of HIPAA compliance, while reducing costs and time to market.

TTC brings hands-on experience within the Health and Life Sciences Industry including Healthcare, Med-Device, Pharma, BioTech, CROs, and Generics. We support clients in overcoming software quality problems related to the software development lifecycle, regulatory compliance, and legacy IT software. Our expertise in Quality Engineering and software testing solutions for the Health and Life Sciences industry improves software quality, customer satisfaction, and resource utilization. Our team has extensive experience with common systems like Salesforce Health Cloud, Oracle, Cerner, SAP, Veeva, Epic EHR, Meditech, IQViA, PerkinElmer, Workday, and many more.

Our Solutions

TTC Global’s Quality Engineering specialists have tested a variety of health industry software systems. Our comprehensive approach to software quality and specialized software testing gives our clients piece of mind that risks have been managed and reduced. Take advantage of TTC's quality assurance and energy industry software testing best practices.

Testing as a Service

TTC Global’s Testing as a Service (TaaS) provides organizations with significant opportunity to deploy testing into their environments without having to scale up headcount and its associated logistics. With TaaS, you can utilize TTC’s world-class testing capability on demand or as scheduled via a resourcing program that flexes around your individual organizational needs

Our outcome-based delivery model means we provide remotely managed, 24/7 automated testing with instant deployment. Centralized progress reporting can be provided to your own internal SharePoint site where you can access reports at any time, providing the flexibility for you to monitor and audit our progress independently.

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Quality Transformation

A packaged, flexible, and proven approach for consistent and efficient results. TTC utilizes a complete assessment toolkit including a questionnaire, scoring model, and templates that allows for assessment customization and selective improvement. This methodology has been developed based on extensive consulting experience, having been used to assess both large and small organizations across numerous geographies.

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Automated Software Testing

TTC offers top-of-the-line automation consulting services that allow organizations to not only maximize their resources but also ensure quality outcomes for end users. Our team of experts utilizes best-in-market tools, frameworks, and techniques to help our clients achieve digital transformation automation simplifies end-to-end functional testing by automating tests across all layers of modern enterprise architectures. There are many benefits to be gained by implementing test automation.

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Security Testing

Through comprehensive security assessments of systems, infrastructure, and applications, TTC provides organizations with a thorough understanding of security risks. Furthermore, we present our clients with recommendations on how to address the identified risks and all supporting evidence collected during the assessment. Our consultants conduct these reviews primarily via documentation review and workshops with our clients. Technical Risk Assessments can be combined with penetration tests and/or vulnerability assessments.

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Validation Support Package

Validation can often be a time consuming and costly effort when bringing in new software. TTC Global has developed a Validation Support Package to aid in the required validation of COTS software. This validation package follows the Installation Qualification, Operational Qualification, and Design Qualification of the software, while relying on vendor documentation. TTC assists in creating these documents, with the installation, design, and configuration documented to assist in validation. We meet with your quality and regulatory affairs groups to align documentation to meet current business practices and follow internal guidelines associated with new software. Contact our team to learn more.

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Tools Evaluation

We have extensive knowledge and worldwide experience in the application development and testing spaces. Our consultants evaluate application lifecycle management tools along with your business processes to see which align with your unique requirements. Choosing the right application allows you to have less modification to your current business processes with less change, increasing the performance of the team. Contact our team to learn more.

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Process Evaluation and Improvement

As a consultancy, TTC Global has worked with multiple clients improving processes focused on improved quality, reduced time for execution, and streamlined signatures. These services are focused on shifting from your existing QMS to a Modern QMS following CSA Principles and Digital Validation. Contact our team to learn more about our process evaluation and improvement services.

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QMS Modernization and Digital Validation

In most existing quality management systems today, there is a focus on physical for paper and wet signatures. Digital Validation allows for signatures at the individual requirement and user story level, shifting left the individual approval and rigor applied to each item. The QMS modernization allows for paper and wet signatures to be replaced with their digital equivalent. Contact us to learn how TTC Global can assist your team with this modernization process.

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Pharmaceutical Company Reduces Cost of Software Quality

Background

Background

TTC were engaged by a $40+ billion pharmaceuticals company to improve their approach to software quality with a focus on reducing the reliance on manual testing for their Salesforce solution.

Solution

Solution

Our team initiated a Quality Maturity Assessment to establish a roadmap for the transformation and implmented a number of key practices, incl. test automation and data integrity testing, to improve the quality of their systems.

Results

Results

The adoption of a modern software quality approach had significant benefits including a 95% reduction in test execution time, 90% of defects being found via automated testing and a 50% hard cost reduction.

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Learn more about TTC's software testing capabilities for Healthcare & Life Sciences