Life Sciences & Pharma
Overview
The pharmaceutical and life sciences industry is experiencing a revolution in both business and technology. FDA regulations require certain applications, such as Clinical Trials and Laboratory Information Management Systems (LIMS), to undergo Computer System Validation. Our best practices focus on following FDA guidelines, such as 21 CFR Part 11, Part 820, and Part 58, for validation, electronic records, and signatures. Companies in this industry face new compliance challenges as the industry changes. Agile software testing methodologies are needed to address specific requirements. Logix Guru helps clients reduce costs, increase efficiency, and bring products to market faster. We offer Jump Start kits for immediate needs, as well as a wide range of services. Our IT professionals have extensive experience and use industry best practices for testing IQ/OQ/PQ protocols. All test scripts and results are fully documented to ensure compliance with industry standards.
Testing Experience
Technology testing in a pharmaceutical setting is crucial to ensure the safety and effectiveness of products before they hit the market. There are several key areas that must be tested, including:
Functional Automation: This type of testing is used to verify that the software functions correctly and meets the requirements set out by the client. This ensures that the software is working as intended and that any bugs or errors have been identified and fixed.
Performance:Performance testing is used to evaluate how the software performs under different loads and conditions. This helps identify any bottlenecks or issues that may arise when the software is used in real-world scenarios.
Integration: Integration testing is used to ensure that different systems and software work together seamlessly. This is important in a pharmaceutical setting, where multiple systems and software may be used to manage different aspects of the product development process.
Functional Automation: This type of testing is used to verify that the software functions correctly and meets the requirements set out by the client. This ensures that the software is working as intended and that any bugs or errors have been identified and fixed.
Performance:Performance testing is used to evaluate how the software performs under different loads and conditions. This helps identify any bottlenecks or issues that may arise when the software is used in real-world scenarios.
Integration: Integration testing is used to ensure that different systems and software work together seamlessly. This is important in a pharmaceutical setting, where multiple systems and software may be used to manage different aspects of the product development process.
Security: Security testing is used to ensure that the software is protected from unauthorized access, hacking, and other security threats. This is particularly important in a pharmaceutical setting, where sensitive information is often stored and shared.
Accessibility: Accessibility testing is used to ensure that the software is usable by people with disabilities. This is important to ensure that everyone can use the software, regardless of their abilities.
Compatibility: Compatibility testing is used to ensure that the software works with different operating systems, browsers, and devices. This helps ensure that the software can be used by a wide range of users.
Data migration: Data migration testing is used to ensure that data can be transferred from one system to another without any loss or errors. This is important in a pharmaceutical setting, where data is often shared and analyzed across multiple systems.
Overall, technology testing plays an important role in the pharmaceutical industry, and we, at Logix Guru, help companies ensure that their products are safe, effective, and compliant with industry standards.
Accessibility: Accessibility testing is used to ensure that the software is usable by people with disabilities. This is important to ensure that everyone can use the software, regardless of their abilities.
Compatibility: Compatibility testing is used to ensure that the software works with different operating systems, browsers, and devices. This helps ensure that the software can be used by a wide range of users.
Data migration: Data migration testing is used to ensure that data can be transferred from one system to another without any loss or errors. This is important in a pharmaceutical setting, where data is often shared and analyzed across multiple systems.
Overall, technology testing plays an important role in the pharmaceutical industry, and we, at Logix Guru, help companies ensure that their products are safe, effective, and compliant with industry standards.
Application Experience
Logix Guru can help you with building applications for various requirements in the pharmaceutical and life sciences industry.
Drug Development Laboratory Information Management Systems (LIMS): Logix Guru can help you with building a LIMS system that can manage and track the entire drug development process from sample collection to testing and analysis. This system can help streamline the process, increase efficiency, and ensure compliance with regulatory requirements.
Research Content Management Software: Logix Guru can help you with building a research content management software that can help you organize, store, and share research data and documents. This software can also help you manage workflow, track changes, and ensure data security.
Clinical Trials LIMS Logix Guru can help you with building a LIMS system specifically designed for clinical trials. This system can help you manage patient data, track trial progress, and ensure compliance with regulatory requirements.
Drug Development Laboratory Information Management Systems (LIMS): Logix Guru can help you with building a LIMS system that can manage and track the entire drug development process from sample collection to testing and analysis. This system can help streamline the process, increase efficiency, and ensure compliance with regulatory requirements.
Research Content Management Software: Logix Guru can help you with building a research content management software that can help you organize, store, and share research data and documents. This software can also help you manage workflow, track changes, and ensure data security.
Clinical Trials LIMS Logix Guru can help you with building a LIMS system specifically designed for clinical trials. This system can help you manage patient data, track trial progress, and ensure compliance with regulatory requirements.
Advanced Laboratory Testing Application: Logix Guru can help you with building a sophisticated laboratory testing application that can handle complex testing procedures, data analysis, and reporting.
Clinical Data Warehousing Solutions: Logix Guru can help you with building a data warehousing solution that can collect, store, and analyze large amounts of patient data from clinical trials. This system can help you gain insights and make better-informed decisions.
Electronic Data Capture System: Logix Guru can help you with building an electronic data capture system that can help you collect and manage patient data electronically. This system can help you increase data accuracy, reduce errors, and improve the overall efficiency of the clinical trial process.
Overall, Logix Guru has a wide range of experience and expertise in building applications for the pharmaceutical and life sciences industry. They can help you with their Jump Start kits that address immediate requirements, as well as a wide range of services. They also ensure that the systems meet industry standards and are compliant with FDA guidelines.
Clinical Data Warehousing Solutions: Logix Guru can help you with building a data warehousing solution that can collect, store, and analyze large amounts of patient data from clinical trials. This system can help you gain insights and make better-informed decisions.
Electronic Data Capture System: Logix Guru can help you with building an electronic data capture system that can help you collect and manage patient data electronically. This system can help you increase data accuracy, reduce errors, and improve the overall efficiency of the clinical trial process.
Overall, Logix Guru has a wide range of experience and expertise in building applications for the pharmaceutical and life sciences industry. They can help you with their Jump Start kits that address immediate requirements, as well as a wide range of services. They also ensure that the systems meet industry standards and are compliant with FDA guidelines.
Regulatory Standards Experience
Logix Guru has extensive experience in maintaining specific regulatory standards for the pharmaceutical and life sciences industry. They understand the importance of compliance with regulations and have a team of experts who are well-versed in the industry’s best practices.
21 CFR Part 11 Testing: Logix Guru has experience in testing software to ensure compliance with 21 CFR Part 11, which regulates the use of electronic records and signatures in the pharmaceutical industry. They use industry best practices to ensure that electronic records are accurate, reliable, and tamper-evident.
Quality Audits: Logix Guru conducts regular quality audits to ensure that their services and processes meet industry standards. They have a team of experts who are well-versed in auditing procedures and can help ensure compliance with regulatory requirements.
21 CFR Part 11 Testing: Logix Guru has experience in testing software to ensure compliance with 21 CFR Part 11, which regulates the use of electronic records and signatures in the pharmaceutical industry. They use industry best practices to ensure that electronic records are accurate, reliable, and tamper-evident.
Quality Audits: Logix Guru conducts regular quality audits to ensure that their services and processes meet industry standards. They have a team of experts who are well-versed in auditing procedures and can help ensure compliance with regulatory requirements.
Documentations: Logix Guru understands the importance of accurate and comprehensive documentation in the pharmaceutical industry. They ensure that all their test scripts, results, and reports are fully documented to meet regulatory requirements.
GxP’s Standards Testing: Logix Guru has experience in testing software to ensure compliance with GxP (Good Practices) standards. These standards are regulations for the pharmaceutical industry and cover areas such as quality control, manufacturing, and testing.
IQ/PQ/OQ: Logix Guru has experience in testing software to ensure compliance with IQ/PQ/OQ protocols. IQ (Installation Qualification) testing ensures that the software is installed correctly. PQ (Performance Qualification) testing ensures that the software performs as intended under normal and abnormal conditions. OQ (Operational Qualification) testing ensures that the software operates correctly in the intended environment.
Overall, Logix Guru has a wide-ranging experience in and knowledge of specific regulatory standards for the pharmaceutical and life sciences industry. They use industry best practices and FDA guidelines to ensure that their services and processes are compliant and meet regulatory requirements.
GxP’s Standards Testing: Logix Guru has experience in testing software to ensure compliance with GxP (Good Practices) standards. These standards are regulations for the pharmaceutical industry and cover areas such as quality control, manufacturing, and testing.
IQ/PQ/OQ: Logix Guru has experience in testing software to ensure compliance with IQ/PQ/OQ protocols. IQ (Installation Qualification) testing ensures that the software is installed correctly. PQ (Performance Qualification) testing ensures that the software performs as intended under normal and abnormal conditions. OQ (Operational Qualification) testing ensures that the software operates correctly in the intended environment.
Overall, Logix Guru has a wide-ranging experience in and knowledge of specific regulatory standards for the pharmaceutical and life sciences industry. They use industry best practices and FDA guidelines to ensure that their services and processes are compliant and meet regulatory requirements.
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