Project Management

GxP Ninja principals are PMI (Project Management Institute) trained and can lead projects in any number of flexible work arrangements. GxP Ninja principals are also ASQ (American Society for Quality) trained and can manage Quality people and processes. We may be integrated with contributions from your interdisciplinary team. We may identify third party contracted resources and operate with minimal disruption to your on-going activities. We may use our internal resources to deliver a turn key result. Always, transparency and communication are key.

Software Validation

We create procedures, templates and documents to meet GMP (Good Manufacturing Practices), QSR (Quality System Regulation), and industry best practices. Including project schedule, product risk assessment, process risk assessment, system requirements, traceability matrix, test cases, test plan, test report, and training. With successful outcomes in Medical Device, Manufacturing Software, Pharmaceutical Manufacturing, Enterprise Software, Desktop Software, and more. Case Study: MES. Case Study: IT.

System Testing

Up to and including highest risk Class III medical devices (eg life-support or life-sustaining devices).

Software system testing for medical device products. Deliverables include: test planning, work breakdown structure, gantt chart, brainstorming, system test protocol, system requirements traceability matrix, test case design (normal use case functional tests, error condition tests, boundary condition tests, bug fix tests, regression tests), burn down charts, test execution, bug investigation and reporting, test report documentation. Case Study: IQ OQ.

Software Development

Completed projects include most of the popular Web, computer programming, and industrial automation languages (assembly language for microprocessor, C, C++, CSS, G code RS 274, HTML, Java, Javascript, Jython, PLC ladder logic, PHP, Python, SQL, Visual Basic, …). As well as variants that are developed for specific application domains, such as spreadsheet custom macro, and label printer control. Additional domains include Web Based Software, Manufacturing Software, Desktop Software, and others. Case Study: Ecommerce.

Enterprise Software

Services include testing, validation, and documentation of Enterprise software such as SAP. Including COTS (commercial off the shelf software) portions as well as custom developed software integrations. Case Study: IT

Web Based Software

Web based software validation. Deliverables include: requirements gathering, system requirements, software requirements,  test protocol generation (MS Word), test case design (normal use case functional tests, alternate use case, boundary condition tests, error conditions), test execution (SQL test data creation, 21 CFR 11 electronic records or electronic signatures verification), bug investigation and reporting, and test report documentation. Case Study: MES. Case Study: IT.

Web based software testing. Activities include: automated performance testing (the Grinder open source tool, Jython),  automated functional testing (Selenium open source tool, Python), manual test case design (MS Word), test execution, bug reporting, and test report creation.Case Study: MES. Case Study: IT.

Web based software development. Examples include: customizations (HTML, CSS, PHP, WooCommerce) for CMS (content management systems) based Web sites like WordPress, Joomla, and Moodle. Case Study: Ecommerce.

Medical Device

Medical device software validation. We offer capabilities on both the technical side of software validation (development and testing), and the regulatory side (documentation, approvals). As well as project management of the overall effort. Deliverables may include system requirements, software requirements, risk assessment, system architecture, software design description, code, code review, test protocol, test case design, test execution, bug investigation and reporting, test report, system integration, Installation Qualification (IQ), Operational Qualification (OQ), and user training. Case Study: IQ OQ. Case Study: MES.

Medical device software testing. Our experience includes software testing of medical devices themselves, as well as the supporting software used in their development, testing, and manufacture. Categories of testing may include black box functional testing, white box unit testing, performance testing, and others.Case Study: IQ OQ. Case Study: MES.

Medical device software development. We have diverse experience in software development projects for medical devices. Including systems for information technology, medical device, medical device inspection, and manufacturing. Applications such as: medical device data entry and reporting (complaints database, patient surgical outcomes database), controller of lens bench optical bench for medical device inspection, user interface and control of printer (Zebra) for medical device label printing, control (G code RS 274) of manufacturing equipment (lathe, mill) for medical device manufacturing, programmable logic controller (PLC ladder logic) for machine tool interface to robotic manufacturing cell, and more.

Manufacturing Software

Manufacturing software validation. System requirements, software requirements, risk assessment, test protocol generation (MS Word), test case design, test execution, bug investigation and reporting, test report documentation (MS Word), system integration, and user training.Case Study: IQ OQ. Case Study: MES.

Manufacturing software testing. Examples include: code review (C language), functional testing (normal use case functional tests, error condition tests, boundary condition tests, 21 CFR 11 electronic signatures tests, 20 mA current loop input simulation, programmable logic controller (PLC) digital output verification), test case design, Installation Qualification (IQ), Operational Qualification (OQ) (Minitab), test execution, bug reporting (TestTrack), and test report (MS Word, Agile, Documentum,Ignite).Case Study: IQ OQ. Case Study: MES.

Manufacturing software development. Examples include: medical device optical inspection instrument controller (assembly language, C language, optical inspection bench (Visual Basic), compurterized numerical control (CNC) program generator (C++), computerized numerical controller for lathe (G code RS 274, and GE Fanuc custom macro), controller to machine tool integration (GE Fanuc PLC ladder logic).

Desktop Software

Desktop software validation. Deliverables include: requirements gathering, system requirements, software requirements, test protocol generation (MS Word), test execution, bug investigation and reporting, and test report documentation (Agile, Documentum, Ignite).

Desktop software testing. Activities include: unit testing (C++), functional testing, test case design (normal use case functional tests, error condition tests, boundary condition tests), test execution, bug reporting, and test report.

Desktop software development. Examples include: user interface to medical device complaints Oracle database (Visual Basic, SQL), patient surgical outcomes database (Visual Basic, Access database, help system, hardware security protection, RoboDoc documentation), machine tool program generator (C++, CNC language).