Life Sciences

Compliance with the FDA 21 CFR Part 11 and Health Portability and Accountability Act (HIPAA) has become a concern for many of our customers in the pharmaceutical, life sciences and biotech industries. MKS Integrity is key in aiding these companies with issues related to computer validation and regulatory compliance.

MKS Integrity offers life sciences organizations a robust software change and configuration solution married to highly flexible process and workflow capability (including requirements, test and software configuration management, unified change management, release and deployment support) built on a common platform architecture. MKS Integrity also supports very robust e-signature capabilities, allowing any change to a system to be validated and authenticated, providing a full audit trail. Workflows can be designed to model and automate any process your team may currently employ, making your group more efficient, and providing you with more repeatable, mature and auditable processes.

Our customer Puget Sound Blood Center must meet both 21 CFR Part 11 and HIPAA compliance objectives, and by using MKS Integrity is saving $30,000 to $40,000 annually through increased efficiency across its 40 person IT team.

MKS brings to you significant expertise in the healthcare, pharmaceutical, life sciences and biotech industries. We are the declared corporate standard for software change management at Abbott Labs, and our internal processes have been audited and validated by Abbott, Pfizer, and Johnson & Johnson. MKS Integrity is also GMP certified at Pfizer.