Sponsoring & Speaking at 2018 MWSQA Annual Conference
By jamiemorris,
This post was recently updated on June 14, 2018
We are thrilled to announce another speaking opportunity for Deb Bartel this summer. She will be speaking at the Midwest Regional Chapter Society of Quality Assurance Annual Conference during July 24-25th.
Additionally, we will have a booth where Deb and Jamie Morris will be on hand to meet attendees and learn about their software quality assurance and computer system validation needs.
Deb will be giving a presentation called “Cloud and SaaS in GxP – Getting It Right from the Start”. She previously gave this presentation at the 2018 National SQA Annual Meeting and we’re thrilled to be sharing this topic to a new crowd.
Cloud and SaaS in GxP – Getting It Right from the Start
Date: Tuesday, July 24, 2018
Time: 1:00 PM – 1:45 PM
Cloud computing models and SaaS (software as a service) applications are increasingly being used by regulated companies, such as those producing pharmaceuticals, biological products, and medical devices, as well as organizations conducting clinical trials and GLP studies. However, this is still new territory when it comes to compliance, inspections, and software validation.
For organizations considering the move to a new computing model, the following areas are crucial to address before making the transition:
Cloud computing model selection: Implementation of Cloud computing models can provide many benefits, but also introduce some new, significant risks. Regulations such as 21 CFR 11 and Annex 11 can impact the model you choose and the subsequent actions needed to retain compliance.
Vendor Selection: Transitioning to a Cloud computing model will result in shifting responsibilities from internal IT and Quality Assurance professionals to the vendor’s staff. It’s important to ask the right questions during risk-based audits or in supplier qualification questionnaires to ensure regulatory compliance, system reliability, and business stability.
Vendor Agreements: And finally, a formal agreement, e.g., Service Level Agreement (SLA), is needed. Contracts containing the right terms, KPIs, and responsibilities can be powerful tools for mitigating the quality, regulatory, and operational risks introduced by out-sourced computing models.
Key Takeaways
- Cloud and SaaS benefits, risks, and trends
- Regulatory requirements to consider when selecting a Cloud computing model
- Audit and supplier questionnaire topics for Cloud and SaaS vendors
- Service Level Agreements (SLAs) terms for compliance and risk mitigation
