What to Expect:

For Life Sci­ences com­pa­nies using SAP in GxP-crit­i­cal process­es, sup­pli­er qual­i­fi­ca­tion is a reg­u­la­to­ry require­ment, but orga­ni­za­tions often han­dle it inde­pen­dent­ly, result­ing in dupli­cat­ed effort, cost, and preparation.

Join ASUG and SAP Life Sci­ences experts to explore a col­lab­o­ra­tive alter­na­tive through the Pooled Audit Agree­ment (PAA) mod­el. This inter­ac­tive ses­sion will intro­duce how mul­ti­ple Life Sci­ences com­pa­nies can work togeth­er on a struc­tured, com­pre­hen­sive SAP audit, includ­ing the audit frame­work, scope, roles and respon­si­bil­i­ties, and lessons learned from the estab­lished DSAG pooled audit model.

You’ll also hear how ASUG is work­ing to bring this col­lab­o­ra­tive approach to U.S. Life Sci­ences com­pa­nies, with the first ASUG audit cycle tar­get­ed for 2027, and how orga­ni­za­tions can help shape and par­tic­i­pate in the initiative. 

Speak­ers:

Susan Fin­ger | SAP Cus­tomer Advi­so­ry Life Sci­ences | Germany

Robert Geiger | Lebail­ly | GxP | Prod­uct Owner

Man­dar Par­alkar | VP Life Sci­ences | Glob­al Indus­try Advi­so­ry, SAP 

This Com­mu­ni­ty Con­ver­sa­tion is being brought to you by ASUG Com­mu­ni­ties. To find your ASUG Com­mu­ni­ties, explore here.

In this Com­mu­ni­ty Con­ver­sa­tion, we will:

• Under­stand GxP sup­pli­er qual­i­fi­ca­tion require­ments and what they mean for orga­ni­za­tions using SAP in GxP-crit­i­cal processes. 
• Explore how the pooled audit mod­el works, includ­ing its legal frame­work, audit domains, roles, con­fi­den­tial­i­ty, and shared report­ing process. 
• Learn how a col­lab­o­ra­tive approach can reduce dupli­cat­ed audit effort and cost while sup­port­ing a struc­tured sup­pli­er qual­i­fi­ca­tion process. 
• Hear lessons learned from the DSAG pooled audit mod­el and how that expe­ri­ence is inform­ing the approach for ASUG. 
• Dis­cov­er how to par­tic­i­pate in the ASUG GxP Audit Con­sor­tium and the path toward the first tar­get­ed ASUG audit cycle in 2027.

Sug­gest­ed Resources:

• Explore your ded­i­cat­ed Life Sci­ences Resource Cen­ter to access all pre­vi­ous ASUG Com­mu­ni­ty Con­ver­sa­tions, resources, and mate­ri­als to sup­port your journey.
• To con­nect with oth­er ASUG mem­bers, join the Life Sci­ences Community.
• To con­tin­ue the con­ver­sa­tion, join the Life Sci­ences pri­vate LinkedIn group.

If you have ques­tions in advance of this Com­mu­ni­ty Con­ver­sa­tion, please reach out to us at communities@​asug.​com.