FDA released its final guidance on “Data Integrity and Compliance with Drug cGMP” in December 2018. The main purpose of this guidance was to clarify the role of data integrity in current good manufacturing practice (cGMP). This guidance provides the Agency’s current thinking on the creation and handling of data in accordance with cGMP requirements.
Read MoreFDA released its final guidance on “Data Integrity and Compliance with Drug cGMP” in December 2018. The main purpose of this guidance was to clarify the role of data integrity in current good manufacturing practice (cGMP). This guidance provides the Agency’s current thinking on the creation and handling of data in accordance with cGMP requirements. There is a lack of clarity on how to adopt this guidance in validating Cloud Apps and Infrastructure. If you are using a cloud app to manage any GxP function, understanding the current thinking within the FDA is of paramount importance for ensuring regulatory compliance.
Read MoreVeeva is a powerful cloud platform that can span the entire drug life-cycle (from R&D to Commercial). It is a multi-tenant platform that is constantly evolving - at least three to four new releases a year. Veeva provides a good vendor validation package that you as a customer can leverage. There is only one caveat - the end-user company is still responsible for Veeva validation and cannot pass the buck to the vendor. In other words, you are responsible for the GxP validation of your instance.
Read MoreFDA’s CDRH is planning on releasing a guidance on Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software in 2020 (applicable to non-product CSV only). Currently, it is on their “A” list. There has been a lot of industry chatter about this particular guidance related to computer validation. Everyone is eager to know about FDA’s current position on computer validation. So much has changed in the last two decades and we still don’t know what FDA’s current thinking is when it comes to the “cloud”. FDA has surely managed to keep us behind a “dark cloud”!
Read MoreMany life-science companies are asking the question “Can I move my GxP workloads into the public cloud?” Answering “yes” to this question leads to another question: “What toolset do I need to qualify the various IaaS/PaaS services that are constantly changing?”.
Read MoreThe main objective of this post to answer the following questions. I know a picture is worth a thousand words and so I will do this with illustrations.
Can "Validation" and "DevOps" be used in the same sentence (like vCD - Validated Continuous Delivery)?
Is DevOps a viable model for validated apps in GxP Environments?
How can one ensure the "validation fidelity" in a DevOps environment?
What are the key steps involved in continuously validating a ServiceNow App?
One has to bear in mind that the underlying IaaS and PaaS infrastructure is constantly changing. In fact, the Cloud App itself is continuously changing. In the new cloud world, it does not make any value-sense to pin to an "ancient" version. Thus this Continuous Validation Framework is designed to mitigate these risks and ensure that your ServiceNow app is maintained in a validated state.
Read More
