Sponsoring and Speaking at the 2018 SQA Annual Meeting
By jamiemorris,
This post was recently updated on March 22, 2018
We are excited to be a sponsor at the 2018 SQA Annual Meeting in Anaheim, CA next month. If you are attending this conference, stop by our booth. Our team would love to meet you and answer any of your software quality assurance or computer system validation questions.
Visit with Deb Bartel and Joe Cunningham in Booth #402.
And we are even more proud of Deb, who will be giving TWO presentations during the conference. Read more about each topic below:
Topic 1: Electronic Data Integrity – Take Action Now
Session W
Date: Wednesday, April 11, 2018
Time: 1:30 PM – 3:00 PM
Room: Platinum 3&4
Part 11, Annex 11, and similar regulations have been in place for years to ensure electronic data integrity. However, the FDA, EMA, MHRA, WHO, and PIC/S have a seen the need to publish additional documents in the last few years to address widespread data integrity issues.
By now many IT and Quality Assurance professionals at GMP, GCP, and GLP compliant organizations are familiar with the acronym ALCOA and know that the ALCOA principles are the keys to data integrity. They might even be participating in Data Integrity compliance assessments, much like the Part 11 compliance assessments of a few decades ago. But, what actions will be the outcome? And, can these actions start now?
The answer is ‘yes’. Unlike the Part 11 compliance initiatives of the 1990s, many actions required to address data integrity vulnerabilities can be addressed without expensive computer system replacement programs.
This presentation will describe actions that organizations can take now to prevent or remediate electronic data integrity gaps in the following 10 critical areas: security and user access, audit trails, back-ups, record storage, record copies, validation, issue investigation, out-sourced services, out-sourced systems, and training.
And, since much can be learned from FDA Warning Letters about what not to do, we will look at examples of sometimes common and sometimes surprising data-integrity compromising practices that have been cited in the last 2 years.
Key Takeaways
- Awareness of the top 10 areas to include in your data integrity program
- Actions to take now to prevent future data integrity issues
- Warning Letter examples of what not to do
Topic 2: Cloud and SaaS in GxP – Getting It Right from the Start
Session BB
Date: Wednesday, April 11, 2018
Time: 3:30 PM – 5:00 PM
Room: Platinum 3&4
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
Deb Bartel is a Partner at Praxis Life Sciences where she is responsible for our Computer System Validation (CSV) and Software Quality Assurance (SQA) practice. Since joining Praxis in 2007, she has provided guidance to clients in the pharmaceutical, biotech, medical device, research, healthcare, and software industries. Her expertise is in building practical, effective approaches to meeting quality and compliance challenges by utilizing LEAN, continuous improvement, and risk-based processes. She has nearly thirty years of experience leading quality assurance, validation, and technology initiatives. Deb has BS-Information Systems and MBA degrees from the University of Wisconsin.
