Incorporating risk-based project execution for projects takes an integrated approach to systems engineering and quality. We use a 21CFR11 compliant approach to managing requirements, assessing risk, executing work and generating turn-over packages. Our clients are provided with a strong commissioning and qualification basis that supports validation plans.
Our software development associates have significant experience building solutions for life science companies. We have invested in systems to ensure specifications and tests are captured to ensure client goals are met and systems are fully able to be validated and maintained throughout the life cycle of the equipment. Clients that are not in life science, benefit from the rigorous and efficient processes honed through our years of experience and service to regulated industries.
Working closely with our clients, our data base system can organize all task information throughout the entire project. We use iterative methodologies and deliver thorough documentation and trace matrices at project completion. Designing with validation in mind is standard practice. Keeping systems in compliance through good change control practices is important as well, and we work with our clients to make this as painless as possible.
Our proprietary software package allows fully-controlled, online access for all parties involved from inception to turnover. It is fully customizable to include all document attachments, notes, emails, drawings, change orders as well as progress reporting. All users are given controlled access to only the portions that pertain to their need and can be completely locked out of all other sections.
Once your system is setup and functioning, it is fully repeatable for other, similar projects at your facility. In the end, you have a full Turn Over Package and history of the entire project.
We'd be happy to provide a demo for you.
Please call us for solutions that require:
- Microsoft .NET
- Active Server Pages
- Microsoft NAVISION
- Microsoft SharePoint Server
- Development for BioPharm Quality Applications
- Web 3.0/RDFa/Elmo/Sesame