Operations

Does your business structure help or hurt your DevOps move? “Organizational DevOps” is the enterprise level action for a DevOps strategy and tactics. There is a natural struggle when moving towards DevOps, but therein is the value. First some context … Process or Project  Operations management is the attempt to run things better – in the current […]

DevOps was first introduced in 2008 as an extension of proper development, but shortly thereafter, “OpsDev” was on many of our minds. I believe the earliest mention of OpsDev was 2012 [Randy Clark in UK Business Computing World, “DevOps or OpsDev?”]. Please forgive me if you made an earlier mention! Why the Name Debate? There […]

As we’ve learned in the previous posts in this series, having a thoughtful, thorough cloud vendor qualification process and intelligent SLAs in your cloud vendor contracts will help you maximize the value of the cloud while maintaining regulatory compliance. In addition, here are some tips and best practices to help you knock it out of […]

Establishing the best supply chain possible is paramount to teams and leaders responsible for meeting the product and service needs of their internal and external customers. Fortunately, the supply chain world is constantly evolving and challenging leaders to reevaluate their place within the ecosystem. As innovations in process and technology are introduced, the speed of […]

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 […]

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 […]

Last week Amazon announced the release of a new node for Amazon Connect: Get Metrics. It is available from the Set menu in regular contact flows, customer queue, hold and even whisper flows and allows us to dynamically query queue data. While the Check Queue Status node (available under the Branch menu in some contact […]

While my earlier blog posts were focused on Agile Risk Management, I am taking some time off from this to familiarize myself with a new subject – Time Management. “Time is the scarcest resource and unless it is managed, nothing else can be managed” – Peter Drucker One fascinating way that I have found to help […]

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 […]

In today’s post, the sixth in the series on the TransCelerate Shared Investigator Platform (SIP), we offer guidance and best practices for early adopters of the SIP. For more background information on TransCelreate or the SIP, or for guidance directed toward companies that have not joined TransCelerate or adopted the SIP, see the previous posts. […]

We often hear the phrase “Seek first to understand and then to be understood” or are told to actively listen. While these are important, often time it’s simply not tactical enough. Too often what we hear is skewed by the filters that we (and our audiences) apply. So how do we ensure what we say […]

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, […]