Posts Tagged ‘cloud’

In my previous post in this series, we discussed how to qualify cloud vendors. Once that process is complete, the second step to maintaining compliance is to document your specific regulatory requirements in a contract with the cloud vendor, usually in the form of service-level agreements (SLAs). In this blog post, I include a range […]

Amazon Connect Streams API (Streams) allows developers to create custom agent experiences for Amazon Connect. The code for Streams is hosted in Github and open for community contributions in the form of pull requests. This is the third installment of my running series covering changes to the Streams API. Prior installments can be found here: […]

About EPM Automate EPM Automate Utility enables Service Administrators to automate many repeatable tasks,  including the following: Import and export metadata, data, artifact and application snapshots, templates, and Data Management mappings Upload files into environments, list files, and delete files from the service Download snapshots, reports, and metadata and data files from the service Run business rules on data, and […]

We recently completed a 21 CFR Part 11 gap analysis engagement for a client that was largely using SaaS applications, but had no cloud vendor qualification process in place. They had just been allowing each business unit to select the applications that met its user requirements, accept whatever validation documentation the cloud vendor supplied (if […]

The key to success is putting people first. When companies apply a people-first approach, it pays — literally. Putting that into action can be another story. With only good intentions and no clear strategy, people interested in evolving their business are faced with a painful and often overwhelming task. By starting with the people closest to your […]

Any time you take advantage of a cloud service – infrastructure, platform, or software – for a regulated purpose, you are ultimately responsible for its regulatory compliance, not the cloud vendor. This is critical for you to remember. So, how can you ensure regulatory compliance of a software system you did not build, you do […]

On March 30, 2018, Amazon announced the general availability of Amazon Connect federated single sign-on using SAML 2.0, stating, “You can enable federated access and controls via any SAML 2.0 compliant identity provider, such as Microsoft Active Directory Services, Okta, Ping Identity, and Shibboleth. Once this is done, agents and managers can sign in to […]

Our healthcare team has been working with the University of Colorado over the past couple of years to overcome critical data challenges in healthcare… and the results are exciting. In this blog post, I’ll share how the academic medical center was able to improve security, reduce maintenance, and increase efficiency in support of the university’s […]

As we continue our series on maintaining regulatory-compliant cloud systems, let’s touch on a few key terms. Below are explanations of the primary cloud-hosted offerings available in the market. Infrastructure-as-a-Service (IaaS) When you purchase a software system and opt to have a vendor host it for you instead of installing it on servers you own, […]

Salesforce’s “Summer ’18 Admin Preview Live” highlighted features guaranteed to deliver greater efficiencies to actionable information, cleaner reports, and insights into end-user skill sets. Among the highlights, here are… 5 Features from “Summer ’18 Admin Preview Live” Every Salesforce Admin Should Leverage Last Run Date on Reports Lists In Lightning Experience (LEX), the “Report Last […]

We’ve made it to the pivotal juncture for enterprise cloud adoption. Thought leaders and research firms have predicted 2018 to be a significant year for businesses shifting to cloud-based platforms. Some of the stats: “In 2018, we’ll cross the significant 50% adoption milestone, and cloud applications, platforms, and services will continue to radically change the […]

If your company makes drugs, medical devices, or biologics (vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins), it is regulated. If your company is regulated, then every IT system you use to design, develop, conduct trials, manufacture, package, label, store, distribute, install, or service your products is also […]