Ensure your computerized systems are fully compliant.
Computerized System Compliance is a critical element of the pharma industry. Our expertise in the pharma industry will guarantee your peace of mind.
We’re here to ensure you get the green light with no obstacles in your way.
Operating in the pharmaceutical industry for two decades, we understand the regulatory requirements and customer constraints, this is at the core of our business, and we seek to share our expertise with you.
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Gain regulatory peace of mind with wide expertise that has all your regulatory requirements covered.
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Derisk your operations. Ensure zero business disruption due to quality issues with your computerized systems.
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Focus your time and effort. Increase your efficiency by using the best methodologies based on extensive pharma expertise.
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Reduced time to market. Implement the right quality standards from Day 1 to avoid complications, rework, and regulatory delays.
Achieve the highest level of quality and compliance.
Empowering pharmaceutical to implement compliant and quality computerized systems. After two decades as a QA and validation leader in the pharma industry, this is our bread and butter.
With our rare hands-on digital health and Software as a Medical Device (SaaMD) knowledge and expertise you are able to optimize your processes and procedures and achieve business-boosting synergy between disciplines, like software QA, V&V and automation.
Implement the latest technologies and methodologies, including automated validation, and computerized system assurance (CSA) to greatly increase efficiency and reduce costs.
Block breaches of sensitive data and other confidential information with security built into your SDLC.
Ensure what matters most, including Computerized System Validation (CSV), data integrity and 21CFR Part 11 Compliance and IT QA.
End-to-end IT Compliance Services for the Pharma Industry.
The Pharmaceutical Industry is highly regulated and complex. Our services are developed to simplify these processes and offer you peace of mind.
Our dedicated delivery center possesses multi-disciplinary quality engineering capabilities that cover all aspects of digital health for our clients around the world.
We specialize in ensuring that our clients’ technology is ready according to existing as well as new guidelines, including FDA’s Computer Software Assurance (CSA) guidelines, as well as other global regulations. We provide regulatory peace of mind not only for the present, but also for the future.
We provide manual and automated testing for your digital health or medical devices development.
We implement quality management systems for your digital health, medical devices, software as a medical device (SaaMD) and pharma operations.
Leverage our extensive experience with validation of computerized system in areas such as Enterprise systems (SAP, Oracle, VIVA, Pharmacovigilance, training & Learning Management), production floor systems, automation systems, lab informatics, stand-alone systems, and more.
We ensure your apps are well designed, responsive and intuitive to remove usage barriers and reduce the chance for human error.
We provide SDLC support as well as testing and validation services for your Enterprise Systems, such as SAP, eDMS, Pharmacovigilance, CTMS, LIMS, and more.
Ensure your systems meet Data Integrity Standards, and are fully validated and compliant e.g. HPLC, and more.
Mission Critical Systems such as MES and SCADA must never fail. We ensure they don’t.
A success story
Qualitest Helps St. Andrew’s Healthcare Create Roadmap to Quality Engineering
01—Challenge
The Client wanted to improve its rating on their customer-facing mobile app to help attract new members. After selecting a new solution, the client decided to convert in 4 months, as opposed to the standard 12-month timeline. Speed to market was essential, but thorough testing was required to ensure there were no critical defects in the new system upon release.
02—Solution
Qualitest obtained, organized and researched existing documents and applications to develop test scenarios for desktop, mobile, and data migration needs. We utilized a combination of Agile and Waterfall to move fast, yet efficiently. We managed test cases/execution as changes occurred throughout the project, up until release, to the tune of 4,274 test cases (both desktop and mobile) and delivered the app to market with no critical defects while aligning to the aggressive timeline.
03—Result
The Client was able to achieve their aggressive deployment date, avoiding expense variances associated with project delays. Qualitest provided a complete QA test execution framework by developing a full test suite, UAT test suite, and regression suites that can be reused by the Client moving forward. The Client was able to offer an improved customer experience with a more efficient, user-friendly digital platform.
Diagnosis: Systems at risk. Rx: Qualitest.
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