User Manual

Total Building Solution (TBS)

Building Technologies 049_Archives_and_Libraries_A6

V10271399_a_en.doc

Fire Safety & Security Products 03.2009

5.3 Validation of the processes

Successful validation is possible only when there is comprehensive expertise in the

area of regulatory requirements, relevant system parameters and the interrelation-

ship between the two.

The latest validation recommendations for FDA applications, such as GAMP 5,

suggest that expert suppliers be involved in the validation process whenever pos-

sible. Siemens has fully integrated these functions in the Electronic Validation Tool

(EVT). The EVT increases the efficiency of the validation services up to 20% while

simultaneously improving quality. It supplies detailed information via an intuitive

user interface and permits comprehensive document management.

Naturally, Siemens archives and libraries solutions take official requirements into

account:

- Physical and/or local split between validated and non validated system.

- Tamper-proof storage of all quality related data throughout the entire life cycle.

- Unambiguous access protection with password complexity and aging.

- Integrated audit trail to record all changes made to quality-related data.

- Implemented technologies for the backup and archiving of quality-related data

- Consistent change management and analysis of the impact on the complete

system.

5.4 Security System (SES)

Access Control: Integrated access controls systems, control access to the relevant

archives and libraries zones. We recommend PIN-code readers in archives collect-

ing very valuable assets.

CCTV: Centralized monitoring and/or recording of user activities and user access

via CCTV are giving anytime an actual overview regarding the present personal in

the different classified archives and libraries areas.

Intrusion: In archives and libraries itself are intrusion measure during the closing

hours or when no persons are present inside the archives. In addition, besides the

room protection, peripheral protection is recommended.