Computer Compliance & Cloud Impact – The Auditable Validation Part I

Duration: 90 Minutes
This webinar will speak about the compliance of SaaS applications and Cloud technology services used in GXP, Part 11/Annex 11, HIPAA, and Safe Harbor regulated industries.
Cloud Computing
Instructor: Dr. Teri Stokes
Product ID: 500879

SaaS applications and Cloud services have recently become major players in the IT marketplace serving life science regulated industries. What started out as convenient support for sales forces has now been moving towards parts of the business that are significantly regulated, i.e., Good Practices in Clinical (GCP), Laboratory (GLP), and Manufacturing (GMP) or GXP areas.

Cloud based software as a Service (SaaS) applications provide enticing marketing messages that emphasize "care free" startup and expanded use without extra staffing and internal infrastructure costs. What is not so well explained is the loss of direct control of one's data storage location and loss of direct control of changes to the software itself and changes to the infrastructure platform delivering the SaaS application to your users. The training of cloud support staff in relevant regulations and guidance is another missing element.

What is not so well explained is the loss of direct control of one’s data storage location and loss of direct control of changes to the software itself and changes to the infrastructure platform delivering the SaaS application to your users. The training of cloud support staff in relevant regulations and guidance is another missing element.


Why Should you Attend:
Industry and IT professionals both new and experienced in computer validation are facing new compliance challenges around the implementation of SaaS and other Cloud technology services for regulated data and GXP operations. It is important for them to examine their compliance practices and see where there is an impact with SaaS and Cloud services that calls for a change in approach or documentation to validation, audit practices and data center contracting procedures.

  • Starts with an industry standard auditable validation package model suitable for use by end users, infrastructure providers, and software developers
  • Examines the compliance impact of software as a service (SaaS) applications on industry standard validation of end user performance qualification (PQ) practices
  • Examines the compliance impact of Cloud based IT services on industry standard installation qualification (IQ) validation documentation package
  • Looks at audit concerns and practices for compliance with SaaS product and Cloud service vendors
  • Discusses adaptations to standard packages for OQ/IQ/PQ due to SaaS/Cloud impact
  • Presents the multidimensional regulatory impact on SaaS Apps used for GXP purposes.
Objectives of the Presentation:
This webinar should equip attendees to address the following questions in their own professional environment:
  • What is the compliance difference between a SaaS product and a non-SaaS product?
  • How does an industry standard End User performance qualification (PQ) package change with SaaS/Cloud products?
  • What are the audit concerns for assessing SaaS/non-SaaS vendors?
  • What is the impact of SaaS/Cloud on an industry standard Installation Qualification (IQ) validation package?
  • What are the audit concerns for assessing Cloud/non-Cloud data center vendors?
  • What is the SaaS/Cloud impact for developers of Apps used for GXP purposes and their Operational Qualification (OQ) package?
Who can Benefit:
  • Industries regulated by GXP (GCP,GLP,GMP), Part 11/Annex 11, HIPAA, and Safe Harbor
  • Pharmaceutical, Biotech, Medical Device industries, Clinical CROs & SaaS/Cloud vendors
  • Quality Assurance, QA Director, Regulatory Compliance Manager, Auditor, IT Director, IT/IS Manager, Software & Data Center vendors to these industries, Validation team, CRO QA, software developer, Project manager, System Owner
This webinar comprises 2 training sessions: Computer Compliance & Cloud Impact Part I - The Auditable Validation, We had completed this webinar on 30 June 2015, Recorded Version is available and Computer Compliance & Cloud Impact Part II - Auditable Formal Testing on July 15 2015.

"Computer Compliance & Cloud Impact Part II - Auditable Formal Testing" Click here to see Part 2


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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. Stokes worked as a Medical Technologist in hospitals, researches, and central laboratories. Her transition to computers came from troubleshooting systems reporting laboratory results. She joined Digital Equipment Corporation (DEC) for a 16 year career focused on pharmaceutical computer solutions. Based in Basel, Switzerland 1990-1995, she developed DEC's computer validation consulting practice for customers across Europe and in Japan with a focus on reality-based compliance to global good practice (GCP, GLP, GMP) regulations.

Dr. Stokes established her independent global consultancy in 1996 to coach validation teams, audit internal and external system suppliers, and train people on a common sense approach to system compliance. Dr.Stokes has satisfied clients in North America, Europe, Asia and Africa. She has written three books and published many journal articles.
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