After 14 years, GAMP 5 is by far the longest-running, and therefore best-known, version of the Life Science Computer Systems Validation Guidelines. The need for a renewal was felt and one was issued last July renewed version which contemplates the technological developments of recent years (Cloud, Agile, Artificial Intelligence, Machine Learning, Blockchain, etc.).
GAMP Italy will present the differences featuring this new release during its usual Study Day which this year will be held at Rome on October 20, 2022. This way you will avoid having to re-read them in full!
But we won't just talk about GAMP 5, you'll see the brand new ones CSA guidelines (Computer Software Assurance) finally issued for comments by the FDA on September 13 and which introduce "revolutionary" concepts on the validation of computer systems. An example excerpt: “As a less cumbersome method, the FDA recommends the use of electronic records, such as system logs, audit trails, and other software-generated data, in place of paper documentation and screenshots, to confirm records of verify".
The final version of the document on the integration between machines and IT systems of the GAMP Italia working group and the updates on the work of the Italian working groups on the Cybersecurity and international ISPE on Pharma 4.0 they will be presented by our Mario Testin, coordinator of the Ispe working group on cyber security.
We will talk about the dematerialization of the validation documentation, reviewing various possibilities: from the drafting of the protocols, to their digital signature and the execution of the tests, with also the presentation of some concrete cases.
SOME KEY POINTS OF THE DAY
GAMP 5 2nd edition and CSA (Computer Software Assurance) by FDA
- CSA (Computer Software Assurance) is the new FDA approach to Computer Validation
Integration between machines and IT systems
- Pharma 4.0 Plug & Produce – A digital journey
- URS templates to simplify data integration between machines and IT systems
Dematerialization of validation documentation (Paperless Validation)
- Overview of the different types of Paperless Validation
- A paperless validation management system pilot – VLMS (Validation Lifecycle Management System)
First examples of paperless validation supported by office automation tools
- First experiences of using the self-assessment checklist for Cybersecurity
- Application in a pharmaceutical industry – IBSA
