Computer Validation Facilitates FDA and HIPAA Regulatory Compliance for Healthcare Industries

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.

"When we saw MKS Integrity we realized it met the majority of our requirements for a ‘dream’ change control system. I have personally saved five hours a week since moving from a manual to an automated approval process for change requests translating to an approximate savings of $13,000 per year. The administrative burden associated with filing paper documents and manually creating reports for various user groups has been drastically reduced, and project lifecycles have shortened. Puget Sound Blood Center has benefited from an annual cost savings of $30,000 to $40,000 and quickly achieved a positive ROI on its investment in MKS."

– Peggy Dunn, Director of Information Technology at
Puget Sound Blood Center

Click here to read the Puget Sound Case Study

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.

Choose MKS to facilitate 21 CFR Part 11 and HIPAA regulatory compliance in healthcare and life science industries