Connecting Pharmaceutical Knowledge

GAMP Benelux

Community of Practice

How to write a good URS

“How to write a good URS, including non-functional system & data requirements?”

Sharing good practices about writing a URS, including non-functional system & data requirement.

½ day event with 3 parallel break-out sessions for classroom discussions.

  • System/Access Security: user access and authority controls, system security, cyber security, …
  • Data Security/Integrity: data security, audit trail, audit trail review, …
  • System Availability & Process Reliability: : system backyp/restore,  disaster recovery, stress & environmental controls (e.g. power outage), business continuity

Location : Teva Pharmachemie, Haarlem (NL)

Registration required. Limited seats (max. 50). Free of charge for ISPE Members.

 

Agenda :

13h00

Registration & Coffee

13h30

Welcome & Introduction

13h40

Introduction Teva Pharmachemie (Trinette Stolle)

14h00

The next step in the process : to better User Requirements

(Frans Boeijen, GAMP COP Benelux)

15h00

Classroom poll - Good/Bad URS examples (GAMP COP Benelux)

15h30

Coffee break

16h00

Break-out sessions : Write a good URS

 

-       SYSTEM/ACCESS SECURITY

 

-       DATA SECURITY/INTEGRITY

 

-       SYSTEM AVAILABILITY & PROCESS RELIABILITY

17h50

Plenary session: present/share lessons learned

18h50

Wrap-up & Close

19h00

Food/Drinks (sponsored by Teva Pharmachemie)

 

Event Properties

Event date 19-Apr-2018 13:00
Event End Date 19-Apr-2018 19:30
Registration Start Date 01-Jan-2018
Capacity 55
Registered 54
Available place 1
Cut off date 12-Apr-2018
Individual Price
We are no longer accepting registration for this event
€40 1

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