Efficient Document Control is Essential to Positive Audit Outcomes

•

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Sysmex shares how using Vault QualityDocs for document control accelerates audits and change control processes, and reduces audit prep times.

Technology

Kim Duffy
Rachael Garcia
September 17th, 2018
Sysmex: How
Efficient Document
Control is Essential
to Positive Audit
Outcomes

Introductions
Copyright© 2018 Sysmex America, Inc. All rights reserved. 2
Rachael Garcia
Quality Systems Specialist
Kim Duffy
Manager, Quality Systems

How Did We Choose Veeva?
Copyright© 2018 Sysmex America, Inc. All rights reserved. 3
Evaluated 10 CMS companies
3 brought in-house for live demos
Why was Veeva chosen:
1. User friendly
2. Linked with other Sysmex systems
3. Multiple options to tailor to our needs

Copyright© 2018 Sysmex America, Inc. All rights reserved. 4
How Efficient Document Control is Essential
to Positive Audit Outcomes
Audits and document changes can be disruptive. Sysmex
shares how using Vault QualityDocs for Document Control
accelerates audits, change control processes, and reduces
audit preparation times.

Presentation Objectives
Routine use to ensure compliance
Use of tokens
Change Control
Impact Assessments
Approval process – based on Lifecycle
Version History
During an Audit
Regulatory File
Document Approvers
Change information
Periodic Review History
Copyright© 2018 Sysmex America, Inc. All rights reserved. 5
How we
use
How this
complies
Complies with 21 CFR part 820 and
ISO 13485:2016

Copyright© 2018 Sysmex America, Inc. All rights reserved. 6
Routine Use
to Assure Compliance

Use of Tokens
Copyright© 2018 Sysmex America, Inc. All rights reserved. 7

Change Management: DCC (Doc Change Control)
Copyright© 2018 Sysmex America, Inc. All rights reserved. 8
Complies with 21 CFR part 820
and ISO 13485:2016

Change Management: DCC (Doc Change Control)
Copyright© 2018 Sysmex America, Inc. All rights reserved. 9

Impact Assessments: Dropdowns
Copyright© 2018 Sysmex America, Inc. All rights reserved. 10
o Software validation:
* Effect on current validation
* Risk assessment
o Process validation:
* Effect on current processes
* Risk assessment
o Regulatory Impact:
* Regulatory requirements
* FDA, ISO Standards, Health Canada etc.
o Training Impact:
* Any effect on training
o Quality Impact:
* Any quality related impact

Control Approval Process: Draft to Approve Lifecycle
Copyright© 2018 Sysmex America, Inc. All rights reserved. 11

Control Approval Process: Draft to Effective Lifecycle
Copyright© 2018 Sysmex America, Inc. All rights reserved. 12

Control Approval Process: Initial to Final Lifecycle
Copyright© 2018 Sysmex America, Inc. All rights reserved. 13

Complete Version History
Copyright© 2018 Sysmex America, Inc. All rights reserved. 14

Copyright© 2018 Sysmex America, Inc. All rights reserved. 15

Audit Checklist
Copyright© 2018 Sysmex America, Inc. All rights reserved. 16

Regulatory File
• Creating a Regulatory File
Allows you to:
• Have the necessary documents
at your fingertips when that call
comes in
• Get them printed prior to audit
• Share the view so all auditees
have easy accessibility
Copyright© 2018 Sysmex America, Inc. All rights reserved. 17

Document Approvers
Copyright© 2018 Sysmex America, Inc. All rights reserved. 18

Change Information and Document Review
Copyright© 2018 Sysmex America, Inc. All rights reserved. 19
• What changes were made?
• Why did you make the changes?
• When was the last time the document
was reviewed?

The Benefits of Veeva
Copyright© 2018 Sysmex America, Inc. All rights reserved. 20
Instant document
retrieval time
Faster Impact
Assessments
Open API – SSO
(> usage / < resets)
* Internal / External audits
* Daily usage
* Due dates are set
* Can route to multiple
IMPROVEMENT
Hunting  Instant
IMPROVEMENT
1 month  1 week
IMPROVEMENT
Saved 1 hour per day for resets
Instant access from other systems
Compatible with current systems

Copyright© 2018 Sysmex America, Inc. All rights reserved. 21
Purchase of Veeva Vault QMS to
electronically assign and maintain:
• CAPA Reports
• Nonconforming Reports
• Internal Audit Files
• Supplier Quality Files

Copyright© 2018 Sysmex America, Inc. All rights reserved. 22
“ As we continue our significant growth,
Veeva Vault is a shift toward technology
that will grow with us. It’s a modern,
more innovative tool, that’s user friendly,
efficient and facilitates doing business
with ease.”
- Peter Shearstone VP, RA/QA/CA/MA

Copyright© 2018 Sysmex America, Inc. All rights reserved. 24

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Efficient Document Control is Essential to Positive Audit Outcomes

1. Kim Duffy Rachael Garcia September 17th, 2018 Sysmex: How Efficient Document Control is Essential to Positive Audit Outcomes

3. How Did We Choose Veeva? Copyright© 2018 Sysmex America, Inc. All rights reserved. 3 Evaluated 10 CMS companies 3 brought in-house for live demos Why was Veeva chosen: 1. User friendly 2. Linked with other Sysmex systems 3. Multiple options to tailor to our needs

4. Copyright© 2018 Sysmex America, Inc. All rights reserved. 4 How Efficient Document Control is Essential to Positive Audit Outcomes Audits and document changes can be disruptive. Sysmex shares how using Vault QualityDocs for Document Control accelerates audits, change control processes, and reduces audit preparation times.

5. Presentation Objectives Routine use to ensure compliance Use of tokens Change Control Impact Assessments Approval process – based on Lifecycle Version History During an Audit Regulatory File Document Approvers Change information Periodic Review History Copyright© 2018 Sysmex America, Inc. All rights reserved. 5 How we use How this complies Complies with 21 CFR part 820 and ISO 13485:2016

10. Impact Assessments: Dropdowns Copyright© 2018 Sysmex America, Inc. All rights reserved. 10 o Software validation: * Effect on current validation * Risk assessment o Process validation: * Effect on current processes * Risk assessment o Regulatory Impact: * Regulatory requirements * FDA, ISO Standards, Health Canada etc. o Training Impact: * Any effect on training o Quality Impact: * Any quality related impact

17. Regulatory File • Creating a Regulatory File Allows you to: • Have the necessary documents at your fingertips when that call comes in • Get them printed prior to audit • Share the view so all auditees have easy accessibility Copyright© 2018 Sysmex America, Inc. All rights reserved. 17

19. Change Information and Document Review Copyright© 2018 Sysmex America, Inc. All rights reserved. 19 • What changes were made? • Why did you make the changes? • When was the last time the document was reviewed?

20. The Benefits of Veeva Copyright© 2018 Sysmex America, Inc. All rights reserved. 20 Instant document retrieval time Faster Impact Assessments Open API – SSO (> usage / < resets) * Internal / External audits * Daily usage * Due dates are set * Can route to multiple IMPROVEMENT Hunting  Instant IMPROVEMENT 1 month  1 week IMPROVEMENT Saved 1 hour per day for resets Instant access from other systems Compatible with current systems

21. Copyright© 2018 Sysmex America, Inc. All rights reserved. 21 Purchase of Veeva Vault QMS to electronically assign and maintain: • CAPA Reports • Nonconforming Reports • Internal Audit Files • Supplier Quality Files

22. Copyright© 2018 Sysmex America, Inc. All rights reserved. 22 “ As we continue our significant growth, Veeva Vault is a shift toward technology that will grow with us. It’s a modern, more innovative tool, that’s user friendly, efficient and facilitates doing business with ease.” - Peter Shearstone VP, RA/QA/CA/MA

23. Questions

Efficient Document Control is Essential to Positive Audit Outcomes

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