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 MoreIn this 45 minute webinar, you will learn:
The features a QMS software must offer to support your organization in achieving 21 CFR Part 11 compliance
How cloud-based QMS software can reduce costs and rapidly accelerate your time to implement
How AODocs can be leveraged to help you become, and remain, compliant with 21 CFR Part 11
How Continuous Validation powered by xLM can remove the burden of Computer Software Validation requirements and enable the move to the cloud
xLM is the only ServiceNow Partner that can deliver end to end GxP Validation via an automated platform. XLM provides managed validation service that is Built for Cloud and Cost Efficient. This partnership with ServiceNow can eliminate the burden of manual validation….
Read Moreoday, companies use a variety of cloud software to manage regulated data produced in GxP environments (e.g, clinical trials, manufacturing, etc.). Maintaining compliance and validation is a challenge with continuously-updating Software-as-a-Service.
Read MoreiLink Systems and xLM have joined hands to provide “continuously validated” Microsoft apps and services to Life science customers worldwide. This partnership enables delivery of a range of services that can be a game changer for Life science customers replatforming to Microsoft Azure. Together they have developed a Managed Service Platform designed specifically for life-sciences to “GxP enable” Microsoft Azure implementations.
Read MorexLM and AODocs jointly presented a webinar on how a modern cloud native AODocs QMS is delivered validated! Even companies like Google use this patented AODocs Platform.
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 MorePhiladelphia, PA: 02-NOV-2019: xLM, the company behind an automated platform that can “validation enable” any cloud App, has been a long-standing partner of AODocs. Their alliance however took off to a new level with AODocs recently announcing the launch of AODocs for Life Sciences.
Read MorePhiladelphia, PA: 29-OCT-2019: xLM, the company behind an automated platform that can “validation enable” any cloud App, announced its partnership with Sumo Logic. The partnership will address all validation-related concerns of existing and future Sumo Logic Life Sciences customers.
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