Food & Drug Administration (FDA)

FDA logo

The FDA is the USA authority for licensing drugs and is under the Ministry of Health. The FDA was founded in 1927 with headquarters in Rockville (Maryland).

The FDA's task is to protect public health in the USA. It regulates the safety and effectiveness of human and animal pharmaceuticals, biological products, medical products, food and radiating devices. The regulations apply to products produced in the USA and imported products.
The FDA is comparable in Germany with the TÜV and Ministry of Health.

Important regulation for Siemens AG products
On August 20, 1997, the FDA's rule 21 CFR Part 11 on electronic records and signatures came into force. 21 CFR Part 11 (in brief: Part 11) defines the acceptance criteria of the FDA for the use of electronic records and signatures instead of drawings in paper form and handwritten signatures on paper.

The requirements include the following:

• Validation
• Records of operator actions
• Retention/Protection/Reproducibility/Retrievability
• Access protection
• Electronic signature (certification of equality)

Detailed information on the single products and solutions are available at the following links:

• Information on WinCC in Entry ID: 37940022
• Information on WinCC flexible in Entry ID: 37939984
• Information on the panels in Entry ID: 37940461

Further information
More information on the topic of GMP (Good Manufacturing Practice) is available at the following link:
http://www.automation.siemens.com/pharma

Additional Keywords
Certificate, Directives, Laws

Description:
A general description on the subject of the Food and Drug Administration is available in Entry ID: 37939948.

Solutions in WinCC:
WinCC provides the following options and solutions to fulfill the FDA regulations:

• Access protection
• Audit Trail
• Data archiving and retrieving
• Electronic signature

Access protection:
Access protection is ensured by the software package SIMATIC Logon.
Below are examples of fulfilled requirements.

• The administrator ensures central user administration (enabling, disabling, locking, unlocking, assigning to user groups).
• Unique combination of user ID and password.
• Definition of access rights for groups and users.
• Password ageing
• Initial password
• The user is blocked automatically after a configurable number of failed log-on attempts and can then only be unblocked by the administrator.
• Automatic log-off
• Log functions

More information on the topic of SIMATIC Logon is available here.

Audit Trail:
The Audit Trail is provided by the option WinCC/Audit. WinCC/Audit is for monitoring operator activities in Runtime mode and during the Engineering phase.
Below are examples of fulfilled requirements.

• Process data (defined process values and defined process and operator messages, for example) is stored without the operator being able to make any changes.
• Relevant changes made by the operator in the process visualization system during operation are recorded in an Audit Trail.
• Changes in the user administration are recorded by WinCC/Audit.

More information on the topic of WinCC/Audit is available here.

Data archiving and retrieving:
WinCC has a configurable and scalable archiving concept. WinCC permits you to use local archives to record messages and process values. You can retrieve the collected data at any time during the complete retention period. The WinCC premium add-on "PM Quality" provides another option. More information on the WinCC premium add-on "PM Quality" is available here.

Electronic signature:
SIMATIC Logon provides an interface (API) for configuring the electronic signature in WinCC. The electronic signature is ensured by SIMATIC Logon. The password and user ID are asked for.

Further information:
More information on the topic of GMP (Good Manufacturing Practice) is available at the following link:
GMP -Webcast & Testiminials

Keywords:
Certificate, Directives, Laws