In August of 1997, the FDA released 21 CFR part 11 to the industry. The regulation was met with confusion as to exactly what it meant, who was responsible for the compliance (vendors or end users), and how to make every computer system compliant. The FDA then released guidance documents, the industry grasped on to legacy systems, and software developers started incorporating part 11 compliance functionality. And then came the Scope and Guidance in 2003 and there was light at the end of the tunnel. Fast forward to today; where we have come since the beginning? How has technology changed? Do we know what it all means, or are there still questions to ask? And now with cloud systems, virtual employees, and everything going digital, do we know who is responsible for all those records? Are we any closer to compliance than we were in 1997?

1. Premier Laboratory Informatics Experts
Strategic Planning  Implementation  Validation
www.csolsinc.com
21 CFR Part 11 – 20 Years Later

2. © 2018 CSols, Inc.
Agenda
 Back to 1997
 Back to the Future
 Where We’re Going…

3. © 2018 CSols, Inc.
FIRE UP THE
flux capacitor...
3
We are going Back in Time!

4. © 2018 CSols, Inc.
4
Brief History
Requested by the Pharmaceutical Industry in the early 1990s – they asked the FDA to provide guidelines
• Because computerized systems were widely used
• There was a desire to reduce or eliminate paper-based records and signatures

5. © 2018 CSols, Inc.
The Early Years
 Which systems and records are in scope?
 What exactly are the requirements?
 How soon do my systems have to be compliant?
 What do we do with word processing tools and fax machines?
 My draft documents are considered “audit trails,” right?
 Where does the FDA say how to do “Software Validation”?
 Way more concern and budget around Y2K remediation.
5

6. © 2018 CSols, Inc.
The Early Years
A day in the life…
6
Wake up workstation
using shared lab
credentials
Grab SOP binder
and complete
paper study form
Start a run for a
coworker – make sure
virus protection is off
so run isn’t impacted
Use calculation
spreadsheet on
desktop
Leave early – make sure
to leave workstation
unlocked for another user
to finish run

7. © 2018 CSols, Inc.
Going Through Withdraw
2002
 Modernization – Pharmaceutical GMPs for 21st Century
 Risk-based approach to encourage adoption of new
technologies
2003
 Revoked Enforcement Policy
 Withdrew guidance documents
 Scope and Guidance Released- Enforcement Discretion
7

8. © 2018 CSols, Inc.
Back to the Future
8
A day in the life…
Log into
workstation and
Citrix portal using
unique credentials
Access EDMS for
newest SOP
version, then
return to system
and log back in
after inactivity
Check system
inbox for
workflows
needing attention
Use electronic
notebook and
complete
workflows
Use stats package
interface to run
calculations
Log out of Citrix
and workstation
before leaving early
Check inbox
status later on
phone

9. © 2018 CSols, Inc.
How Far Technology Has Come
9
Security
Accessibility
Availability
Data
Then Now
System accounts
AS/400
Thick Client
Client-Server
Mainly in the Lab
Shared kiosk
Limited functionality
Stored locally
Transferred to media
RAID
AD/LDAP
Single sing-on
Client-Server
SaaS/Cloud/3rd Party
Citrix
Mobile Devices
Lab workstations
Desk/office
Browser based
Data via SDMS
Network
Cloud – Public/Private
Hosted

10. © 2018 CSols, Inc.
How Far We’ve Come
 Part 11 risk assessments and requirements are standard
 Better definition of electronic records
 Elimination of paper to reduce hybrid systems
 Replacing “legacy” and in-house built systems
 Increased training and knowledge
 Software vendors made enhancements
10

11. © 2018 CSols, Inc.
So, Are We There Yet?
 It depends…
 Are electronic records and signatures now considered out-of-
the-box?
 What about metadata?
 Do you know where your data are at any time?
 Did you set it and forget it?
 Is your risk-based approach too risky?
11

12. © 2018 CSols, Inc.
So, Are We There Yet?
Examples from Warning Letters
 Failed analytic results were hidden
 Altered time/date settings
 Analyses re-integrated to achieve passing results
 Routine retesting of analytic data and deleting original results
 Disabling system audit trails
 Completed batch records days after operations ended

13. © 2018 CSols, Inc.
FIRE UP THE
flux capacitor...
13
We are going Back to the Future!

14. © 2018 CSols, Inc.
Where We’re Going
14
 The Cloud (AWS; box)
 Metadata remaining linked to applicable record?
 Signatures still intact?
 Audit trails capturing accurate time stamps?
 Who has access?

15. © 2018 CSols, Inc.
Where We’re Going
15
 Hosted Systems (SaaS)
 Where are the data?
 Can you get all the data back?
 How much control do you have over
configuration?
 How much do I have to validate?

16. © 2018 CSols, Inc.
Where We’re Going
16
 Technology
 Smart watches and other wearables
 Voice recognition (e.g., Siri, Alexa, etc.)
 Remote workforce environments
 Virtual/Augmented Reality

17. © 2018 CSols, Inc.
Summary
17
 We have come a long way
 Technology hasn’t solved everything
 Data Integrity reinforcing part 11
 21 CFR part 11 still important

18. © 2018 CSols, Inc.
18
www.csolsinc.com

19. © 2018 CSols, Inc.
CSols Vision
CSols Inc shall be recognized as the premier
Laboratory Informatics Consultancy in North America
by earning and maintaining a reputation for
excellence in everything we do.
All CSols relationships with employees, clients and
partnerships will be characterized by integrity,
quality and high value.
CSols is committed to making our world a better
place and will allocate a portion of our profits to
helping those less fortunate.
19

20. © 2018 CSols, Inc.
CSols Services
 Strategic Planning & Selection
 Implementation
 Computer System Validation
20
Guiding You to an Exceptional Destination

21. © 2018 CSols, Inc.
Industries We Serve
 Agriculture
 Biotechnology
 Chemical/Petrochemical
 Clinical
 Consumer Products
21
 Forensic Science
 Medical Device
 Mining & Metals
 Oil & Gas
 Pharmaceutical
 Contract Testing Lab
 CRO/CMO
 Energy
 Environmental
 Food & Beverage

22. © 2018 CSols, Inc.
CSols Partnerships
Our Current Partners Include:
22