Domain Expertise & Competence
By virtue of the enormous experience of its experts in Life and Laboratory Sciences, NuLEAP assures you complete competence.
Collectively, the NuLEAP Team has hundreds of man years of experience designing, developing, deploying and supporting enterprise scale Informatics systems for the Life Sciences and related markets. We routinely design, develop and support software for use in regulated environments and provide complete software development life cycle documentation and validation services for development projects.
Product & Applications Development:
- NuLEAP’s “product oriented” approach takes advantage of our strong product development, deployment, validation and systems integration experience. We apply this methodology to even the smallest development projects, ensuring high quality, scalability, timely delivery and excellent support.
- All development work follows a rigorous software development life cycle model including Requirements Documents, Design Documents, Functional Specifications Test Plans and additional supporting documentation. NuLEAP delivers all software development projects with a Certificate of Structural Validation.
Systems and Business Process Integration:
- The NuLEAP team has direct experience with software integration projects including SDMS, LIMS, ELN and Content Management Systems among others.
- We have assisted customers with business process mapping, flowcharting their laboratory business processes to identify operational and data flow bottlenecks. The results of process mapping engagements include technology and workflow recommendations to streamline workflow and data flow throughout the Informatics Value Chain. Our Systems Integration team works closely with customers towards implementing the recommendations into systems and processes that positively impact the way our customers do business.
Regulated Markets Experience:
- 21 CFR Part 11, GxP Compliance
- Validation: Structural, IQ, OQ, PQ