Checklist for effort estimation of a Serialization project

Question Answer
A General
1 Is your company active as an MAH (Marketing Authorization Holder)? Yes
1.1 What is the amount of Rx products, which you distribute as MAH?
1.2 What is the amount of Rx packaging, which you distribute as MAH?
2 Is your company active as a CMO (contract manufacturer)? Yes
2.1 How many customers do you supply?
2.2 What is the amount of Rx products, which you package as a CMO?
2.3 What is the amount of Rx packages, which you manage as a CMO?
2.4 Are you provided with serial numbers as a CMO already (e.g. for an order)?

3 Doesyour company contract CMO for packaging? Yes

3.1 How many CMO do you contract?
3.2 What is the amount of Rx products, that CMO package for you?
3.3 What is the amount of Rx packages, that CMO manage for you?
4 Relevant markets/countries
4.1 Germany
4.2 other EU (amount of countries)
4.3 China
4.4 Turkey
4.5 South Korea
4.6 Brazil
4.7 Argentina
4.8 Saudi-Arabia
4.9 Russia
4.10 USA
4.11 other (please list)

B Current situation
5 Which country/countries have the first priority for you?

6 What is your schedule for the introduction of a Serialization solution?

(if applicable by phase, phase 1, phase 2, phase 3,..)
7 Is there a project team already? Who are the contact persons?

C Site & Line Level

8 Do you have the technology in use for managing Serialization on Site-Level?

8.1 Which machines/devices are already capable for Serialization?

9 Please name all production sites

10 How many lines are supposed to be used at each site for Rx products?

11 What lines/packaging machines do you use (manufacturer, model)?

D Serialization
12 Is there any possibility to generate and/or provide serial numbers already?
Yes

E IT infrastructure
13 Do you operate the IT infrastructure by yourself or via a third party partner? Yes

14 Which ERP systems do you use?

15 Which database systems do you use?

16 Which software do you use for packaging and the logistics?

Contact: +49 721 6634 357

talk@systec-services.com

(c) 2016 Systec Service GmbH www.systec-services.com