In this webinar, not only will we take you through what you’ll need to do to prepare for an audit, but we will also share what you can do to contribute to continuously improve and maintain oversight of your QMS.

2. How to Prepare
for an Audit and
Maintain
Oversight Within
Your eQMS
December 3rd, 2019
2

3. House Keeping
3

4. 4
House
Keeping
L I V E W E B I N A R
• This webinar is being recorded and
will be made available after this
session
• Feel free to use the chatbox to
submit your questions at anytime
• Q&A will take place at the end of the
webinar
• We will send these slides to your
email at the end of the webinar

5. 5
Meet Your Speakers
Sara Naushin
Sales Engineer,
Montrium
Tamara Mitchell
Content Specialist
Montrium
Madison Ramsay
Marketing Operations Lead,
Montrium

6. • Founded in 2005
• Working Exclusively in the Life Sciences
• Headquartered in Montreal, Canada
• EU HQ in Brussels
• Clients in North America, Europe & Asia
• Leading Content Management Platform
• Over 8000 Users in 20+ Countries
• Experienced Professional Services Group
6
About
Montrium
Connecting People,
Processes & Technology
A B O U T T H E C O M P A N Y

7. The Growth Platform for Emerging Life Science Companies

8. Agenda
1. What the auditors are looking for?
2. How to prepare for an audit
3. The importance of using the right communications strategy
4. How to show if you comply with the defined quality system
processes
5. How to minimize observations and get the best possible
outcome
6. What results can be achieved through the implementation
of an enterprise QMS or eQMS
7. Audit Debrief
8. After the audit: responding to findings and requests

9. So, what is the
auditor looking for?
9
Presented by Tamara Mitchell

10. 10
Audit A systematic, independent and
documented process for
obtaining audit evidence and
evaluating it objectively to
determine the extent to which
audit criteria are fulfilled

11. 11
QMS
Audits
Evaluate an existing quality
management program in order to
determine its conformance to your
company policies, contract
commitments, and regulatory
requirements.

12. What are the
auditors
looking for?
• Compliance with your procedures
(SOPs) and showing that these
procedures align with the regulations
• Evidence in the documentation
produced when following SOPs
• To ensure that quality is maintained
throughout the process

13. What the auditors
are looking for -
cont'd.
• Indication that your business
processes are planned out and have
assigned objectives or standards that
they should perform to
• What controls are in place to ensure
that your process conforms to both
your company’s internal requirements
and the requirements of external
organizations

14. Auditors are
looking to see
that you…
1. Say what you will do
2. Do what you say
3. Can prove it!

15. How to prepare for an
audit
15
Presented by Tamara Mitchell

16. 16
Audit
Fundamentals
• Plan far in advance!
• Break up long hours into a few days
• Coordinate with your key team
• Advise your staff
• Assign tasks

17. - SOP Listing along with document number,
title, revision numbers to show what
procedures you have in place and what
activities you monitor
- Organizational Chart allows you to verify
training records
- Training Records including CVs, signed job
descriptions, training certificates
- The Evidence which would allow you to
demonstrate compliance with procedures
Which
documents
should you
prepare?

18. An internal quality audit is an audit that is
performed by or at the direction of members
of your organization
• Benefits:
• Identify any training gaps and problem
areas
• Verify integration of QMS usage into day-
to-day activities
• Build confidence and find opportunities for
improvement
• Identify potential findings and address
them prior to an external audit
18
Do an internal
audit

19. • Your management review should look over
your entire quality management system at
least once a year
• Top managers should review your quality
processes, objectives for the next year, non-
conformity issues and corrective actions
• Additionally, the results of internal audits as
well as any changes to processes
and regulations should be reviewed
Schedule
ongoing
management
reviews

20. • Review customer complaints,
previous GxP inspections and audits, and
any other open deviations, incidents, or
CAPAs. Are these all up to date with
appropriate close-out actions?
• Ensure that you know who to contact if
there is something that you can’t find
during the audit
• Clear your big commitments on the day of
to reduce stress
• It’s important to make sure the workspace
is clean and well-organized
• Clear away any visible records to avoid
having a breach in confidentiality
Maintenance
and
Housekeeping

21. • SOPs are ambiguous and not directive
• Many SOPs were out of date or not effective and
approved just prior to the audit
• Employees do not appear to know which SOPs
they should be following for a specific process
• There is no evidence available to show that an
SOP was followed – Documentation was either not
required or not produced
• Training records are missing
• An employee completed 20 Read and Acknowledge
trainings in 20 minutes
• Records are not dated, or dates are ambiguous
• ALCOA is not met for records
• Incorrect versions of forms / documents are being
used
21
Easy findings
for auditors

22. ü Plan the audit and notify your staff
ü Prepare your documents
ü Do an internal audit
ü Schedule ongoing management reviews
ü Maintenance and housekeeping
ü Avoid those "easy findings"
22
In summary:
Your Audit
Prep Checklist

23. Using the right
communications strategy
23
Presented by Madison Ramsay

24. Built-in,
NOT added on.

25. A positive
Culture of
Compliance is:
• Established by top management and led by
example
• Integral to information systems and their use
and management
• Embedded in all activities
• Inseparable from the organization’s structure,
processes, and management style
• Reinforced regularly

26. Effective
compliance
communication
involves:
1. a clearly understood commitment to do
the right thing
2. appropriate mechanisms in place to
gather and maintain evidence of
compliance

27. • Company culture of fear, blame, lack of
awareness and overcomplicated
processes.
• Poorly communicated and misunderstood
policies and standards.
• Inadequate internal audits
• Pressure to avoid incidents such as out-
of-specification (OOS) situations that cause
delay.
Root causes of
Quality Issues

28. How to show you comply
with the defined quality
system processes
28
Presented by Tamara Mitchell

29. Auditors typically examine the Quality
Management system to determine:
1. The level of commitment that management
within the company has to the current quality
system
2. Whether you have established and followed a
schedule for tasks, internal audits and reviews
3. That there is an effective quality management
system in place and minimal ambiguity
29
Ensure
alignment to
your Quality
Management
System

30. • Make sure you can locate
everything you will require during
the audit
• You don’t have to know where
every little detail is, but make sure
there is a good directory or table
of contents in reach
• Know who is responsible for
different aspects of the system
Location,
location,
location.

31. Auditor is looking to see…
• Your SOPs are being adhered to,
objectives are being met
• They can be accessed easily
• They align with the regulations
31
What
alignment
looks like
for SOPs

32. • To show that you've done adequate
training and value continuous
improvement
• Demonstrate your onboarding process
with records (CV, job description, SOPs
read and acknowledged)
• Quizzes to validate that employees
understood their training
• Show how you’ve set up automatic
training renewals for employees to
renew their knowledge in relation to
compliance
What
alignment
looks like for
Training
Records

33. • Emphasis on constant refinement of processes
and procedures is key to reduce your chances
of receiving a Form 483
• Auditors will check your records for corrective
actions that you took in response to an error
and preventative measures
• Confirm that the recommended actions have
been implemented and documented
• Show what prevents this problem from
happening again
• Show what would detect the problem
How to show
your CAPA
process
complies

34. • Prepare your available documentation and
records of:
• All changes (fixes, enhancements, major
revisions, emergencies)
• Risk analyses completed for each
requested change
• Who was responsible for each change
• All of this to show you’re actively mitigating
internal and external risks and complying to
the change control procedure
34
How to show
your change
control
management
process
complies

35. How to minimize
observations and get the
best possible outcome
35
Presented by Sara Naushin

36. 36
Set yourself up for success
Create a map of your
terminology
This will help with
alignment so there are no
confusions
Look out for that Audit plan
The auditors must provide you
with an audit plan which will
cover the scope of your audit, so
don’t agree to the audit if they
don’t provide you with one- you
need to know what to expect.
Keep in mind you can also
propose changes to the audit
plan if need be, and so you can
have a say to what happens
when, in order to set yourself up
for success
Create an auditor access
in an eQMS
Make sure that they are only
seeing what is in scope of the
audit and nothing more

37. 37
• Know your regulatory standards!
• Keep compliance and training
records easily accessible
• Have an audit plan ready
• Perform internal mock audits
• Take accountability
The Do-s and Don’t-s of Audit
Preparation
Do’s Don’ts
• Rely on binders and stacks of
paper documents!
• Try to hide and delay a finding
• Debate and get defensive
• Wait to talk to your team members
on how to stay compliant
• Leave your KPIs negative and wait
to fix them at the last minute

38. 38
Mock Audit
The goal of a mock audit is to:
• Improve your processes by defining those areas of
weakness you may currently have
• Allow you to be audit-ready and improve performance
• Help to expose any potential violations giving you a
chance to fix them before a formal audit
• Help to improve communication within your team
• Help you identify who your key players are, so that you
can include them during the next formal audit

39. 39
Conducting
a Mock
Audit
To begin, you must first:
• Establish the scope of the audit
• Build an audit plan
• Plan out the mock audit by selecting an
auditor, a time and an internal team to
participate
• Conduct the audit by reviewing procedures and
corresponding documents and data
• Provide a closing summary and report.
• Follow up
• Consider a 3rd party to conduct the mock audit.

40. Implementation of an
enterprise eQMS
40
Presented by Sara Naushin

41. How are you currently managing
your QMS?
1) Paper
2) File share
3) Hybrid – paper and file share
4) eQMS
5) I’m not actively involved in managing our
QMS
41
POLL

42. • Simplicity and Visibility
• Centralized System for
Documentation
• Easy Access to SOPs and
Training Records
• Faster Communication and
Easier Correspondence
42
Why an
eQMS?

43. SOP Connect
Training Connect
CAPA Connect
Automate the entire lifecycle of
your controlled quality documents
Automate the planning, completion and
tracking of GxP training more efficiently
Centralizing and Empowering Continuous
Improvement in Incidents, Quality Events
& CAPAs
Enterprise Quality
Management Software in
the Cloud

44. • Readily available listing of all your quality documents
• Periodic reviews for your Effective Controlled Documents
• Leverage our Training Overview Report to view training
completeness on any level
• Generate KPIs on any metadata field collected
• Fill gaps in trainings on your employees
• Report on Incidents and create CAPAs
44

45. Are you interested in receiving
more information about
Montrium’s Quality Connect?
1) Yes, could be useful
2) No, not interested
45
POLL

46. Audit Debrief
46
Presented by Madison Ramsay

47. 47
Audit
Debrief Make sure to:
• Write down what they are saying
• Ask if you will receive the audit report from them
or from the mandating party
• Ask what their expectation is for the response
• Ask what they consider Critical, Major, Minor or
recommendation
• Ask to see references to what they are referring to
when they explain their findings
• Ask when you will receive the audit report

48. After the audit:
responding to findings
and requests
48
Presented by Madison Ramsay

49. 49
The Audit Report
What to do when you receive it
STEP 1
• Make sure you
understand it
completely
STEP 2
• You either
propose a
corrective
action to make
a requested
change or you
can disagree
STEP 3
• Continue back
and forth
communication
until all
disputes are
resolved.
STEP 4
• Once all
disputes have
been resolved,
and the
corrective
actions have
been
implemented,
the auditors
will provide a
close out
communication

50. 50
After the
close out
Determine how you can apply your
lessons to your:
• Policy
• Procedures
• Compliance narratives
• Evidence quality
• Training activities etc.
Conduct a post
audit lessons
learned meeting
with your team

51. INFO@MONTRIUM.COM
Thank You!