Learn about When and how to use paper to your advantage in a regulated environment in theis presentation by Melita Ball and ZenQMS

1. Document Control in FDA
Regulated Environments:
When (and how) to stick with paper

2. Melita Ball
Regulatory & Quality Training
Remediation
Warning Letter mitigation
Quality System Development
21 CFR Part 11
Software Validation
Supplier Qualification &
Management
Auditing
Document Control
Production & Process
Control
CAPA
Complaint Handling
Management Controls
Project Management
• Principal Consultant, MBC & Affiliates, LLC (MBCA)
• 25+ years working in FDA regulated environments
• Global Consulting Firm specializing in regulatory compliance and
quality system

3. Agenda
Predicate Rules
Why paper-based systems are simple
Why paper-based systems are complex
How to do it right … on paper
When is it time to automate?

4. Predicate Rules:
Documents & Records
Definition
A predicate rule is any requirement listed in FDA regulations
that requires compliance to demonstrate a “state of control.”
Since these rules were originally written for paper-based
quality systems, it is sometimes difficult to translate those
rules into the variety of systems that exist in today’s modern
manufacturing environments.
In today’s session, we will focus our attention on the
predicate rules as they apply to documents & records.

5. Predicate Rules:
Documents & Records
Historical Background
Most regulated companies implemented their first quality
system on paper because technology was not what it is
today.
Since then, computer systems and automated tools have
burst into our daily lives and have made their way into
companies with the promise of working smarter & faster.

6. Predicate Rules:
Documents & Records
Historical Background
Automation has also allowed companies to achieve more
consistent results with less human error and to make better
data-driven decisions.
All of this sounds fantastic to most people, until they are
faced with implementing those tools in a way that ensures
not only compliance with the predicate rules but also
ensures they can actually rely on the data and information
coming out of the system.

7. Predicate Rules
Summarized
What are they?

8. Predicate Rules:
Summarized
Documents
1. Approvals with date and signature
2. Documents must be available at the point of use
3. Obsolete documents must be prevented from unintended
use
4. Changes must be reviewed approved with date & signature
5. Approved changes must be communicated to the people
who need them in a timely manner
6. Must maintain change history of each document that
includes a description of the change, a list of affected
document, signature/date of approval, & when change
becomes effective.

9. Predicate Rules:
Summarized
Records
1. Maintained at the location of use or reasonable
accessible during an inspection.
2. All records must be made readily available for review
and copying by the FDA
3. Must be stored to minimize deterioration and prevent
loss
4. Must be legible
5. Must be retained for appropriate period of time
according to individual regulations.

10. 8 Rules of Recordkeeping
1. Always use ink to create a permanent record.
2. Provide all requested information. Never leave
unexplained blank spaces.
3. Always correct mistakes by drawing a single line
through your error insert the correct information, initial
and date the correction.
4. Never use whiteout or anything else to hide the original
entry. You must be able to read the original entry.

11. 8 Rules of Recordkeeping
5. Always sign and date any Quality System Record.
6. Always write neatly and legibly.
7. When recording data, always copy information directly
to the data sheet or notebook. Never record data on
scrap paper or post-it-notes.
8. Always record ALL data. Never be selective. You must
be able to explain & justify any data not recorded

12. Paper:
Beautiful Simplicity & Ugly Complexity
Now, lets take a quick look at how
most companies implement these
requirements in a paper-based
system.

13. Paper Documents

14. Paper Documents
o Approvals with date and signature

15. Paper Documents
o Documents must be available at the point of use

16. Paper Documents
o Obsolete documents must be prevented from
unintended use

17. Paper Documents
o Changes must be reviewed and approved
date/signature

18. Paper Documents
o Approved changes must be communicated to the
people who need them in a timely manner

19. Paper Documents
o Must maintain change history of each document that
includes a description of the change, a list of
affected documents, & when change becomes
effective.

20. Paper Records

21. Paper Records
o Maintained at the location of use or reasonable
accessible during an inspection.
 Standard practice is to maintain the quality
system records for a specified period of time
in one central location in the organization for
easy retrieval.
 Older records that still need to be kept but
are in the archive stage should be sent to an
offsite location for long term storage.

22. Paper Records
o All records must be made readily available for review
and copying by the FDA.
 Throughout the record retention period, records must be
able to be retrieved within a reasonable amount of time
during inspections.
 If the records are recent and you’ve done a good job of
centralizing and organizing them, this is not a huge
problem but what if the documents are old and have
already been moved into long-term storage?
 They must be close enough to retrieve them within a
reasonable amount of time for FDA inspections.
 If you use a third-party vendor like Iron Mountain, you
need to negotiate guaranteed delivery time-frames into
the contract.

23. Paper Records
o Must be stored to minimize deterioration and prevent
loss
 This is an extremely important concept in the paper
world because paper does deteriorate over time and it
can easily be destroyed by water, fire and other natural
disasters.
 Industry standard for short-term storage
 Fire & water rated file cabinets
 Industry standards for long-term storage
 Storage rooms with fire rating
 Temp & humidity systems with notifications
 Water detection systems if location is in basement or
below sea level or in an area that frequently floods
 OR – contract with a document management company
to do it for you (Iron Mountain)

24. Paper Records
o Must be legible
o This seems like a simple requirement but it is difficult
to control consistently with paper records.
o Even if you use electronic tools to create records
where possible (Word, Excel, etc.), employees will
eventually need to manually enter data on a paper
record with a pen.
o Industry Standard is to require all employees to print
information on a form (no script writing allowed) and
monitor legibility during internal audits that look at
records.

25. Paper Records
o Must be retained for appropriate period of time
according to individual regulations.
o Depending on which FDA segment you fall into and
your products general expected life, this can vary
widely from company to company.
o One of the most stringent requirements is for
complex medical equipment that can have a 25-30
year life in the field. For these systems, paper
records will need to be maintained for the expected
life of the device PLUS two years.
o Retrieval of records is the least of your worries as
deterioration of the paper and/or ink become a more
important factor.

26. 8 Rules of Recordkeeping:
Paper vs. Electronic
Paper
Blue or black ink is the best
because they have more
carbon and last longer
when archived
No gel or erasable ink
No pencil
Electronic
Record is electronic but should
be printable. Laser printers
are best for “permanence”
E-Systems need to be
validated to ensure the record
is permanent after saving and
cannot be subsequently
changed.
Backups, archives, system
maintenance
1. Always use ink to create a permanent record.

27. 8 Rules of Recordkeeping:
Paper vs. Electronic
Paper
If the approved form has a
space for data, it must have
something in it or an
explanation for why it was
left blank.
N/A is not always sufficient
and sometimes will require
an explanation.
Electronic
Optimally, the E-System will
be workflow enabled and
this can be validated.
If not, controls need to be in
place at the field level that
prevent a user from moving
forward with blank fields.
2. Provide all requested information. Never leave unexplained
blank spaces.

28. 8 Rules of Recordkeeping:
Paper vs. Electronic
Paper
Every mistake on a record
must be corrected using the
above method.
Electronic
This rule is accomplished by
valid audit trails that show
who made the change,
when, why, and the old and
new values for the field in
question.
Out of the box in many
systems but validation still
needed.
3. Always correct mistakes by drawing a single line through your
error insert the correct information, initial and date the correction.

29. 8 Rules of Recordkeeping:
Paper vs. Electronic
Paper
Whiteout, whiteout tape,
markers that obstruct the
previous information, etc.
Also includes scribbling out
the old value.
Must be able to read the old
and new values.
Electronic
In an E-System, it is the
same solution as the
previous slide
Audit Trails that have been
validated.
4. Never use whiteout or anything else to hide the original entry. You
must be able to read the original entry.

30. 8 Rules of Recordkeeping:
Paper vs. Electronic
Paper
We covered this earlier
Fairly simple and self-
explanatory
Electronic
Must be the equivalent of a
persons hand-written
signature
Signature cannot be denied
in a court of law
Much more complex than a
simple hand-written
signature (Part 2)
5. Always sign and date any Quality System Record.

31. 8 Rules of Recordkeeping:
Paper vs. Electronic
Paper
Harder to control
Harder to maintain for the
long term
Must be a part of ongoing
improvement efforts and
monitored for effectiveness
Electronic
Barring simple typos, much
easier to maintain neat and
legible records using electronic
systems.
Interfaces to other systems,
table-driven data fields that
auto-populate or have a logical
tree or are select fields all must
be thoroughly validated to
ensure data integrity and
accuracy.
6. Always write neatly and legibly.

32. 8 Rules of Recordkeeping:
Paper vs. Electronic
Paper
Harder to control
Harder to maintain for the
long term
Must be a part of ongoing
improvement efforts and
monitored for effectiveness
Must be part of ongoing
training efforts.
Electronic
Some of the same issues as
paper if employees insist on
writing it down before
entering into the system
In addition to control listed
on left side, there may be a
need to invest in technology
to make it easier to comply
(tablets, laptops, etc.)
7. When recording data, always copy information directly to the data
sheet or notebook. Never record data on scrap paper or post-it-
notes.

33. 8 Rules of Recordkeeping:
Paper vs. Electronic
Paper
Dependent upon the
enforcement of #7
Difficult to detect but
consequences are severe if
found.
Electronic
Dependent upon the
enforcement of #7
Difficult to detect but
consequences are severe is
found.
8. Always record ALL data. Never be selective. You must be able to
explain & justify any data not recorded

34. Paper to Software Test
When do you know
“it’s time to automate?”

35. The Paper to Software Test
1. How many documents do you
currently have in your quality
system
2. How many records do you have?
3. On average, how many records
does your company create every
week?

36. The Paper to Software Test
4. Do you have relatively-stable
process for document changes?
5. Do you have relatively-stable
process for product & process
changes?
6. How many employees to you have
using and changing documents
and creating records?

37. The Paper to Software Test
1. How many documents to you currently have
in your quality system?
1 – 150 = 1
151 – 550 = 3
More than 550 = 5

38. The Paper to Software Test
2. How many records do you have?
1 – 1,000 = 1
1,001 – 5,000 = 3
More than 5,000 = 5

39. The Paper to Software Test
3. On average, how many records does your
company create every week?
1 – 15 = 1
16 – 50 = 3
More than 50 = 5

40. The Paper to Software Test
4. Do you have relatively-stable process for
document changes?
Document Changes:
Yes = 5
No = 1

41. The Paper to Software Test
5. Do you have relatively-stable process for
product & process changes?
Product & Process Changes:
Yes = 5
No = 1

42. The Paper to Software Test
6. How many employees to you have using
and changing the documents and creating
records?
1 – 25 = 1
26 – 75 = 3
More than 75 = 5

43. The Paper to Software Test
Add the answers to each
of the six questions
together for a total score

44. Paper to Software Test
Answers
If your total score is from 6 to 13, you either
don’t need or are not ready to implement an
electronic system.
If you received this score based on the answers to
questions 4 & 5, then more experience is still needed
to understand change control requirements. Once
these are well understood and stabilized, you will
likely be ready to implement and electronic system in
a cost effective way.

45. Paper to Software Test
Answers
If your total score is from 14 to 23, you
are a great candidate to move from paper to
an electronic system.
Additionally, the timing is perfect to optimize
the transition.
You likely have worked out most of the
process issues on paper and have a good
grasp of what’s needed and why.

46. Paper to Software Test
Answers
If your total score is from 24 to 30, you have
waited too long already.
Get moving!
It’s past time to automate and the sooner you
transition, the easier your life will become.
You likely have introduced a fair amount of complexity
into your processes and it will be important for you to
get some help to ensure you select the right system
and make necessary adjustments to fit into your culture
with minimal interruption.

47. Don’t Miss Part 2!
June 24th at 1:00 Eastern / 10:00 Pacific
Sign up at http://tinyurl.com/ZQpart2 or look for an
email from ZenQMS shortly
In part 2 we will take a deep dive into what it takes to
prepare your organization for a successful transition
to a software driven system.

48. THANK YOU!
MELITA BALL, PRINCIPAL CONSULTANT
MBC & AFFILIATES, LLC
& ZenQMS
www.mbcaconsulting.com
(520) 665-9081
mball@mbcaconsulting.com
www.zenqms.com
(267) 670 8999