IT systems in healthcare & Life Sciences organizations are required to meet stringent compliance regulations as laid by GxP, CSV, CFR part 11, HIPAA etc. And since companies that can demonstrate better patient outcomes will hold a distinct competitive strength, they must know how to comply with the HIPAA / other rules or better yet, find a partner that can navigate and help them achieve this compliance. Healthcare CIO organizations have significant experience in delivering on premise compliant systems. However, developing and deploying compliant systems in the cloud is still a challenge.


Customer challenges

There are concerns about:

  • Security (is my data vulnerable?)
  • Data privacy, data transfer (where is my data going to be located? Am I complying with the regional/local requirements of data privacy and transfer?)
  • Services architecture how do I provide my customers with a seamless view of my applications on the cloud and those on the legacy environment?
  • Cloud provider – Sponsor handshake/R&Rs how do I set up the support structure and controls to handle application management in the cloud?

Solution overview

CloudMoyo’s Compliant Cloud Framework helps organizations build capabilities to host, develop, integrate and migrate to the cloud environment by building the right processes, tools and services, and controls. In a guided process, CloudMoyo helps organizations:

  • Assess landscape & Select the right cloud environment
  • Choose from a set of available tools/capabilities to match their enterprise requirements, leveraging CloudMoyo’s reference architecture
  • Deploy processes, tools & services, and controls to meet the requirements of HIPAA, GxP, CSV, CFR part 11.

Benefits

CloudMoyo Compliant Cloud solutions can help organizations meet their regulatory standards while benefiting from the use of cloud applications. CloudMoyo system validation for part 11 is a detailed process and is important for quality and safety, and record integrity. The approach to part 11 requirements such as Validation, Audit Trail, Legacy Systems, Copies of Records, Records Retention has been implemented with few of the top 5 Pharmaceuticals client.

Once a company is assured that data is protected and that data safeguards are compliant to regulations, it can look to broaden the cloud’s impact in three distinct areas such as clinical trials, R&D, Consumer Engagement. By working with a healthcare-dedicated cloud partner, healthcare organizations can glean real answers from this data, now strongly secured and compliant, to drive discovery and innovation.