Your trainers

Chris St Amour Christy Mazzarisi

Head of Solutions Consulting Principal Consultant

Dawn Niccum Maria Veleva

SVP QA & Compliance Principal Consultant
The Building Block Approach to QMS
Development in Scaling BioPharma
Your trainer

Christy Mazzarisi
Principal Consultant

With over 17 years of industry experience as Head of Quality and a Quality systems professional, Christy is
most passionate about continuous improvement activities and consistently building quality into each area
of the life sciences. Her background? Think pharmaceutical and laboratory sciences, R&D and commercial
manufacturing, GMP & GLP, leading to strategic management of major programs such as gap analysis and
transformation of Product Quality Systems (PQS), SOP transformation and optimization, QMS frameworks,
and operational systems audits. So basically, the gamut.
Agenda
§ Top Challenges
§ Tactics for Success
§ eQMS Vendor Selection
§ What Does Good Look Like
§ The Building Block Methodology
§ A Phased Approach to QMS development
§ Creating a Quality Management Strategy
§ Proactive System Monitoring
Top eQMS Challenges Across
BioPharma Landscape
Quality Culture
• Unclear roles and accountability or ownership of
the Quality teams and systems
• No vendor or site governance
• Top-down quality culture approach
Strategic Vision & Execution
• Redundant or lack of metrics (KPIs/KQIs)
• Reactive data approach
• Unclear Quality strategy tied to corporate goals or
a harmonized approach across sites
Software & Systems
• Complex or inefficient processes that differ across
sites and/or buildings
• Lack of robust tools to maintain data holistically
• Inability to properly adapt efficient change
management across enterprise
Fit for purpose
Quality Management System

Regulatory Compliance Data Integrity & Security Proactive Risk Management

• Data/system mapped landscape to create a pathway • Ensure Regulatory expectations and supply/demand
• Build a fit-for-purpose & scalable QMS that meets for efficient systems to elevate the standard of needs come together for a proactive and holistic
regulations and supports industry best practices Quality approach to Quality
for your organization • Creates efficiencies within processes, gives value added
• Safeguard data by setting the right data security
requirements at each level of the eQMS time back to employees
• Support continued collaboration across
departments and sites to consistently meet and • Reduction in risks, system supports consistent delivery
demonstrate compliance to requirements within the requirements needed to catch and monitor
risks
One Step at a Time…
Agile Framework
Employing an optimal set of tools to
design a change management
blueprint tailored to a dynamic
Quality framework, aligned with the
corporate objectives and ethos;
while staying compliant amidst
evolving regulations.
Robust Tools
Leveraging the right tools and
streamlined methodology to
expedite harmonization and
implementation across the
enterprise.
Holistic Model
Ensuring the system and processes
mirror the organization’s vision and
core values, facilitating effective
operations that adhere to
compliance standards.
 How to select the right vendor

Product Company
User Experience Features Technology Implementation
Maturity Reputation
• Best practices • Design meet current • All necessary • Cloud vs. Traditional • SMEs for • Financial position
• Global capabilities user interface needs components for a • Align with company implementation? • Business model
• Robust roadmap • Easy to configure robust system infrastructure • Host the system? • Organization size
• History of user • Quality built in? • Scalable? • Implementation and structure
experience • Easily integrated approach robust?
with other systems?
In-house eQMS vs Cloud-based eQMS

• More resources required to service and maintain the
system (validation activities, release requirements, etc.).
• Troubleshooting becomes an IT and Quality function.
• Additional responsibilities put on the sponsor for disaster
and back up recovery, upgrades, network access and
bandwidth and providing scalable solutions.
• Vendor is responsible for validation activities & release
efforts.
• Vendor can provide troubleshooting support, and
disaster recovering and management.
• Enhanced network access and managed service
support.

As organizations move to a more virtual or hybrid approach to global product development, cloud-based systems are
becoming the “go-to” for robust and compliant eQMS needs.
What Does Good Look Like Anyway!?

Objectives aligned with the

Quality Manual corporate quality vision with an
Keeping Quality by Design (QbD) in mind emphasis on quality culture
fostered by leadership which
prioritizes a risk-based approach to
Tools Systems Processes harmonization

SOPs, SOPs, SOPs,

Training & Training & Training &
Controlle Controlle Controlle
d d d
Document Document Document
s s s

Metrics, Governance & Oversight

The Building Block Approach
to Biopharma QMS
STEP 3 STEP 4
Build Implement & Sustain
Configure to your process, Train, migrate (if needed), perform
involved SMEs, write SOPs, and lessons learned, system review &
perform CSV hyper-care.

STEP 1 STEP 2
Strategy & Planning Prospecting & Prioritization
Gap analysis, vision build & Evaluate vendors, gather
create a roadmap. requirements, prioritize tasks

Quality & Change Management

Key to a successful implementation
Phased Approach to eQMS Implementation
Lorem ipsum
Continuous Improvement, APQRs...Down the
road when ready for commercialization
Phase 4
Complaints
Inspections Phase 3
Phase 2 Audits
Change Control Supplier Qualification
Quality Events
CAPA/ECs

Phase 1
Document management System
Learning management System
 Create a Quality Management Strategy

2 3
1
Requirement Gathering Roadmap to the Future System Execution

• Define shared vision and key priorities
with leadership teams.
• Perform a gap analysis of current state &
remediation plan.
• Create a project plan with key activities
and milestone deliveries.
• Utilize accelerators in crafting a
comprehensive QMS strategy, complete
with detailed plans that align with
priorities.
• Ensure inclusion of change management,
stakeholder analysis, process optimization
and training.
• Create a governance framework,
assemble a core team for implementation
and facilitate and project manage all
essential activities.
• Proactively monitor risks, put mitigations
in place, and support periodic program
reviews for improvements.
1 Requirement Gathering - Share the Vision

3
2 4
Prioritize gaps for
Perform a gap analysis remediation to achieve

1 & identify gaps in

current state with a
the vision. Stakeholder analysis
vs. upcoming changes 5
vision-focused to system/process.
mindset.

Leadership vision Create a holistic

building & expectation project plan to
setting. prioritize and plan key
milestones.

Kick-Off Phase 1 Key Milestone 1 Achieved

2 Roadmap to the Future- Path to Excellence

3
2 4
Establish a roadmap
against the holistic
project plan, keeping Create a change
1 Identify what
accelerators can be
aligned to key
priorities.
management plan, that
looks at training at the 5
used to maximize time
forefront of system
against milestones.
implementation.
Support process
development and
Determine business harmonization as a key
and IT requirements. part of the change
management plan.

Kick-Off Phase 2 Key Milestone 2 Achieved

3 System Execution

3
2 4
Provide hyper-care
support to trainers and Ensure a plan has been
1 Develop roles and
responsibilities that
trainees. set for continuous
improvements and 5
are communicated
periodic system
organization-wide.
monitoring.
Develop metrics and
Set a clear governance dashboards to support
and oversight proactive risk
structure. management within
the QMS.

Kick-Off Phase 3 Key Milestone 3 Achieved

Single Source of Truth
A holistic QMS supports a culture of quality within an organization; promoting proactive and data driven decision making
for leaders

Adhoc
§ All GxP departments Documentation
§ Performance KPIs
§ Controlled Documentation Internal
Information

Holistic Risk management

alerts
QMS
§ Partners
Metrics &
§ Vendors External
§ Regulatory Agencies Information monitoring reports
§ Third Parties (CRO/CDMO)
Proactive Monitoring
Proactive Risk Management
1 Real-time analytics that support a proactive approach
to handling risks and identifying bottlenecks.

Continuous Quality Improvement

2 Robust analytics that helps Senior Leadership see
areas needed for continuous improvement initiatives.

Holistic Dashboards
3 Dashboards that contain good data and proper translation of
information to allow for adequate oversight of company
operations and vendor performance.

Reduction of Efforts
4 Having proactive monitoring, by way of robust analytics, allows more time
to be spent on value added activities by reducing duplications of
events/documents, ensuring training is performed, and having on-time
audits.
Key Takeaways

§ Understand your business goals and objectives

§ Select a vendor that fits your company culture and vision
§ Create a plan for success
§ Use a phased approach
§ Think proactively in how you build your system/process
NEXT SESSION
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