Tips And Best Practices For Compliance In The Cloud

Perficient - Digital Transformation

As with any regulated software or hardware, you still need documented procedures that address business use and quality assurance (QA), especially computer system validation (CSV) and change control. As a general guide, the cloud vendor will own the technical procedures (which you will qualify during cloud vendor selection and enforce in your SLAs), and you will own the application procedures, with quality assurance procedures overlapping.

Key Takeaways About Compliant IT Systems In The Cloud

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And, finally, ensure you have the appropriate application-level and quality assurance procedures in place to support the use of each system, once it has been validated and release for production use. Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technology

Why Fax Numbers still matter


For this reason, faxed documents are used in clinical trials and in other highly regulated activities in the pharmaceuticals industry and government bodies. Consequently, communications managers may want to consider including fax numbers in their overall quality control plan and strategy.