Tags » Computer System Validation

Why is Computer System Validation Important in FDA Regulated Industries?

Asking why Computer System Validation (CSV) is important in FDA-regulated industries is like asking why an engine is important to a vehicle.

Before going on to get an understanding of this issue, let us understand that there is a difference between the ways in which the term “validation” is used in the general area of computers and that used in FDA-related circles. 367 more words

Fda Compliance

Pharmacovigilance Best Practices Part II: Consortium Initiative

In Part II of ARITHMOS‘ article series on pharmacovigilance best practices, we address the need of project implementation and maintenance by introducing the Consortium initiative which helps companies significantly reduce costs while receiving expert advice from cross-functional teams. 384 more words

Pharmacovigilance Practices Part I: Argus Data Migration

In this two-part blog, ARITHMOS takes an extract from its article series on migrating safety data and cases from legacy pharmacovigilance systems to Oracle Argus. ARITHMOS describes the process involved in data migration and validation principles and considerations during the production phase to ensure efficient and cost-effective pharmacovigilance practices. 386 more words

FDA 483s & Warning Letters and How to Avoid Them

This week ARITHMOS has been focusing on Computer System Validation and the importance of implementing a proactive approach to system validation and maintenance. In this week’s blog post, we look at FDA warning letters, what they mean and how to avoid them by following the computer system validation life cycle. 531 more words

Webinar On User Acceptance Testing

Current regulations expect that all users are appropriately trained and that must include being trained how to effectively perform UAT.

This course provides an understanding of the role of users in system validation and covers good documentation practice and the writing of UAT scripts. 222 more words

Biologics

Quality by Design: Risk-Based Approach to Clinical Trials

Last week, ARITHMOS attended the GIQAR conference in Italy which focused on managing changes to GxP guidelines. ARITHMOS’ Stefano Piccoli presented at the conference on the topic of Quality by Design and how to prevent failure in monitoring by anticipating and mitigating risk when it comes to technology solutions. 405 more words

A Strategic vs Maintenance Approach to Computer System Validation

As mentioned in our last blog post on IT quality, the costs associated with poor quality outweigh the costs of investing in validated, quality systems. IT quality and validation deliver systems which are fit for their purpose and comply with pharmaceutical regulation requirements. 408 more words