Your partners for Project Management, Software Validation, and Software Development services.
Contact Us for your next fixed bid, hourly, 1099, or W-2 project!
Project Management
Our principals are PMI (Project management Institute) trained. With successful outcomes in new product validation, documentation for FDA submission, FDA warning letter gap analysis, spreadsheet validation remediation, software risk assessment and validation, More …
Software Validation
We have successfully completed software validations in diverse areas. Such as medical device products, pharmaceutical manufacturing execution systems, medical device inspection, software tools, and CSV (computerized systems validation). We will create procedures, templates and documents to meet your quality and regulatory requirements. 21 CFR 820.30, 21 CFR 820.70, 21 CFR 11. FDA GPSV, IEC 62304, IEC 60601, ISO 9001, ISO 13485. More …
Software Development
We create new programs to your specifications: gather requirements, design, conduct reviews, code, document, validate, install, and train.
Also maintain your existing software. Modify, update, troubleshoot, document. Add features, upgrade to new operating environment, re – validate legacy software for new standards or for bug fixes, More …