Looking at the different legal and regulatory requirements that surround ELN projects

1. ELNs and Compliance
Simon Coles

2. Copies of these slides
http://www.amphora-research.com 2

3. ELNs and Compliance
• Compliant with what?
• Typical approaches
• Common problems
http://www.amphora-research.com 3

4. About Amphora
• Started in ELNs in 1996
• Globally deployed, fully electronic ELN
for Kodak
• Grew from there...
• Now work with large & small companies
• Biotechs, Pharma, Chemicals
http://www.amphora-research.com 4

5. Who we work with
5

6. Industry
http://www.amphora-research.com 6

7. What we do
• Patent Evidence Creation & Preservation
• Make lawyers happy
• Which means you can make scientists
happy
http://www.amphora-research.com 7

8. What we do
• Sometimes our stuff is used...
• Standalone (e.g. CRT presentation)
• In conjunction with other “ELN”
products (e.g. Solvay, Array etc.)
• With in house systems (e.g. J&J)
http://www.amphora-research.com 8

9. “ELNs and
Compliance”
http://www.amphora-research.com 9

10. Compliant with what?
• The world cares about what your company
does and how you do it (Regulation)
• You want to be able to prove what you did
so you can get the credit for it (Patents)
• You have some internal requirements for
retention & use of scientific data
http://www.amphora-research.com 10

11. What is an ELN?
• Helpful to distinguish
• The different functionality that is
provided by ELN systems
• The different data which is created in the
Research Lab
http://www.amphora-research.com 11

12. What’s in an ELN?
“Broad” aspects
Security, Collaboration, Patent Protection etc.
Chemistry Biology etc. etc.
http://www.amphora-research.com 12

13. What’s sloshing
around?
• Not all the “Stuff” on our hard disks is the
same
• Various levels of abstraction
• Need to keep it for different periods
• Different levels of importance
http://www.amphora-research.com 13

14. Different types of stuff
Programmes
Projects
Experiments
Interpreted Data/Reports
Analysed/Processed Data
Raw Data
http://www.amphora-research.com 14

15. Records Requirements
Quality Material to be
Scrutiny Timescale Format
criteria preserved
XML
Internal Scientific data
Internal use Little, if any Company defined De Facto standards
requirements Experiment write up
ad hoc
Published Primarily Scientific
Regulatory XML
Regulatory regulations, with data Defined by regulations
inspection De Facto standards
comment Some write up
~ 10 years before first
Case law Primarily Experiment PDF
come under scrutiny
Patents Federal Rules of write up Adversarial Paper
Retain for 50 -100
evidence etc. Some data Microfilm
years
http://www.amphora-research.com 15

16. Regulatory Compliance
• Regulatory authorities want you to work in
a certain way and require proof that you
did
• They also want to be assured you’re
creating the records that are needed to
diagnose/trace/fix issues
http://www.amphora-research.com 16

17. Regulators
• Medical, e.g. FDA and other national
counterparts
• Environmental, e.g. EPA
• Employment, Health, etc.
http://www.amphora-research.com 17

18. Regulators
• Generally the people who are performing a
regulated activity are intimately away of
their regulatory responsibilities
• There will often be an individual or group
within the organisation who are
responsible for your relationship with the
regulator
http://www.amphora-research.com 18

19. ELNs in a Regulated
area
• The regulator is generally interested in
what you did and how
• It is impossible to split the record keeping
layer and the activity
http://www.amphora-research.com 19

20. Regulated areas
“Broad” aspects
o ut
te into
ra g
Security, Collaboration, Patent Protection etc.
pa pin er
Se ee ay
’t K
an rd L
C o ra te
ec Sepa etc.
Chemistry R Biology etc.
a
http://www.amphora-research.com 20

21. Have to do this
is
ng p”,
pi e
ee De ity
k “
rd he onal
Chemistry eco
Biologyt ti
etc. etc.
R t of unc
ar ific f
p c
s pe
http://www.amphora-research.com 21

22. Different types of stuff
Care an awful lot
about the lower Programmes
levels Projects
Experiments
Interpreted Data/Reports
Analysed/Processed Data
Raw Data
http://www.amphora-research.com 22

23. ELNs in a Regulated
Area
• “Generic” ELNs are rare in a regulated
area
• Often, the thing that replaces your Paper
Notebook may not even be called an “ELN”
http://www.amphora-research.com 23

24. Paper Notebook
Replacements
• SDMS
• Compliance Management Systems
• LIMS
http://www.amphora-research.com 24

25. Keeping Lawyers Happy
• In Discovery, at some point you’re going to
have a clever idea
• Your lawyers will want to patent it
http://www.amphora-research.com 25

26. Patents and Records
• You get a patent primarily for what
happened in someone’s brain
• Hopefully you have some record of that
• Which you then take into court
http://www.amphora-research.com 26

27. Patents and Records
• Unfortunately a patent case is conducted in
a court of law
• This makes it somewhat of a blood sport
• Your records have to survive adversarial
scrutiny
• Ideally you haven’t got anything hanging
around which causes you a problem
http://www.amphora-research.com 27

28. Keeping Lawyers Happy
• Some kind of Patent Evidence Creation &
Preservation Process/System
• Will take records from all systems
• Author Signed, and Witnessed
• Long retention periods for the experiment
writeups
• Get rid of everything else
http://www.amphora-research.com 28

29. Surviving Court
• Designing Patent Evidence Systems is an
interesting game
• Lots little interdependencies
• Technology is only a small part of it
• In fact, the less technology the better!
• All about simplicity and reliability
http://www.amphora-research.com 29

30. Keeping Lawyers Happy
“Broad” aspects
st
u n
m io
Security, Collaboration, Patent Protection etc.
ly at
te ar
lu ep
so s
b is
A th
d o
Chemistry Biology etc. etc.
http://www.amphora-research.com 30

31. Different types of stuff
Keep Experiment
Get rid of this stuff as Writeups for a long
soon as prudent Programmes time
(assuming you don’t Projects
need it for any other Experiments
reason)
Interpreted Data/Reports
Analysed/Processed Data
Raw Data
http://www.amphora-research.com 31

32. Interesting Thoughts
• A lot of people in Discovery aren’t keeping
the right stuff in their notebooks
• Sometimes too detailed, sometimes not
enough
• Sometimes the people keeping the best
notebooks don’t need to keep them
• Sometimes the people who should aren’t!
http://www.amphora-research.com 32

33. Interesting Thoughts
• The lawyers don’t want to torture you
• Really, honestly
• You can create good patent evidence
reasonably painlessly
• Decent front-end system
• Good backend
http://www.amphora-research.com 33

34. Interesting Thoughts
• Scientists are happy and productive
• You don’t spend all that much money (good
ROI!)
• Lawyers get a reliable process and good
evidence
http://www.amphora-research.com 34

35. Questions?
http://www.amphora-research.com 35

36. Copies of these slides
http://www.amphora-research.com 36