Ray Verhoeff

1
Security

• Ray Verhoeff
• Vice President Engineering

2
Agenda

• Operating System Security
• PI Server Security
• PI Clients
• Auditing
• Best Practices White Paper

3
Motivation

• Widely held misconceptions
• Pharmaceutical Industry audits

4
What do these have in common?

• Complete Works of Shakespeare
• The Bible
• California Tax Code
• Tao Te Ching
• 21CFR11

5
Answers

• None are clear or specific
• Subject to interpretation
• Have inspired great minds to debate the issues
  for hours
• Commentaries now outweigh the original document

6
21CFR11

• Electronic Records
• Code of Federal Regulations
• Not Law
• Not Standard
• Subject to interpretation
• Details will be shaped by FDA rulings

7
Examples

• Electronic Signature
• Human Readable

8
21CFR11 Tug-of-War

• Users want software to handle everything
• Vendors push for Standard Operating Procedures
  (SOP)

9
Misconceptions

• PI files are installed Everyone/Full Control
• piadmin/pidemo have no password
• No login prompt when on Server console
• PI does not support Windows integrated login

10
PI Installation

• Setup is a starting point
• Site must configure PI for its own environment

11
Physical Security

• This means locking the computer room
• Access to the hardware can always compromise
  security
• Reboot
• Power off
• Pull network wire

12
Operating System Security

• Groups, Users Passwords
• control access to privileged accounts
• File Permissions
• Auditing

13
Usernames Passwords

• Domain users
• Independently validated by Domain Controller
• Passwords
• Lifetime min max
• Length
• History
• Complexity

14
Windows Auditing

• You can track just about any operation
• Login/Logout
• File Operations
• creation
• deletion
• execution
• change permissions/take ownership
• Traverse Folder

15
Windows Event Log

• All audit messages go here
• Security group
• Do not configure Overwrite as Needed
• Loss of audit trail
• SOP must be in place
• backup audit trail
• manually purge

16
File Permissions

• PI Server will run with D\PI set to
• Local Administrators/Full Control
• Everyone else/Nothing

17
Standard Operating Procedures

• Control access to Domain Administrator account
• No auto-login
• Dont expose PI directory as File Share
• You may expose the PI backup directory
• read-only

18
PI Server Security

• PI Firewall
• restrict access to your IP domain
• PI Trust
• dont map to piadmin
• PI Users and Groups

19
Connecting to PI

• PI API vs. PI SDK
• Connecting vs. Logging In
• The Default User

20
The Default User

• no name, cant assign one
• no group, cant assign one
• gets world access
• Disable this in PI 3.3 SR2
• if disabled, PI Server appears empty
• Degrade to this if you attempt a login and fail!

21
Windows Integrated Login

• Login to Windows Login to PI
• You still need to
• Control which Windows users are PI users
• Assign ownership and permissions of PI points,
  etc.

22
PI Trust

• Strong start with PI Trust table
• Supports Windows domain membership as well as
  TCP/IP credentials
• Domain,User,PIuser as OSI,, is powerful
• PI ICE uses this exclusively

23
PI Client User Experience

• PI API clients attempt a login
• Gives perception that PI does not support Windows
  login
• PI SDK clients attempt a trust lookup
• If trust is Domain-based, you have integration

24
PI SDK Clients

• PI Point Builder
• PI Tag Configurator
• PI Auto Point Sync
• PI ICE 1.0
• PI ProcessBook 3.0
• PI Datalink 3.0

25
21CFR11 Audit Requirements

• Record Windows username of editor
• Contents are unreadable
• Contents cannot be tampered with
• Maintained outside primary data store

26
PI Audit Requirements

• Cannot detract from the primary function of the
  PI Server
• To support this
• Audit trail cannot be read on-line
• PI does not process or format the trail
• pidiag -xa
• PI Audit Viewer

27
PI Audit Viewer Edit
28
PI Audit Viewer Detail
29
PI Audit Database additions

• PI Batch database auditing
• PI Module Database auditing

30
PI Audit Database futures

• Auditing of new events for specific points
• Workaround code using replace mode when
  inserting data

31
Best Practices White Paper

• Gives details of Windows and PI configuration
• Many thanks to OSIsoft Field Service
• Supplements PI in Compliance

32
Questions?
Without Action, there is no Benefit. Empowered
people take better Actions!
ACT
People Need Pictures, Graphs, Trends specific to
their Role
VISUALIZE
Get the Information to people who need it
DISTRIBUTE
Aggregation, Analysis, Reconciliation,
Calculation, Cases
ANALYZE
Make the data relevant to users
ASSIGN CONTEXT
Data Collection from Inside and Outside the
Corporation
GATHER EVENTS DATA