Organization
| LSOPS01: How do you identify applicable regulatory frameworks for your workload? |
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Life sciences workloads must comply with various regulatory frameworks (FDA, EMA, HIPAA, GDPR) depending on application type, data sensitivity, and operational geography. Failure to identify applicable frameworks creates operational risk through regulatory incidents and potential service disruptions.
| LSOPS02: How do you implement regulatory oversight throughout your project lifecycle across the identified frameworks? |
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Regulatory oversight requires structured governance to maintain regulatory adherence as projects evolve and team members change. This includes establishing leadership roles, defining oversight processes, and consistently applying regulatory requirements across each project phase.
| LSOPS03: How do you verify that services from external vendors have been approved by your teams to meet regulatory requirements? |
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Regulatory requirements extend to vendor solutions, requiring a proactive approach to verify regulatory adherence when selecting vendors. When choosing solutions, select only those verified as capable of meeting regulatory requirements by the vendor. Avoid trying to make non-compliant services fit regulatory requirements.
| LSOPS04: How do you establish formal quality oversight of IT? |
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Life sciences regulations emphasize quality management as a key requirement. Establishing IT quality oversight provides the best way to meet IT regulatory requirements while maintaining a separation of responsibilities from pharmaceutical quality systems.
Best practices
LSOPS01-BP01 Regularly identify and classify applicable regulatory frameworks
LSOPS03-BP01 Perform supplier and vendor assessment of each vendor
LSOPS03-BP02 Limit available services to improve regulatory adherence
LSOPS03-BP03 Establish clear definitions of responsibilities between you, vendors, and users
LSOPS04-BP03 Incorporate formal risk management into your IT processes
