Labtopia Solutions PPT for description of business activities

1. Implementing Lean
Getting ROI from your Quality Systems
Tools in the Laboratory
Copyright 2011 Labtopia, Inc.

2. What does Quality Mean to You?
We can help you execute
management systems based on ISO
standards, regulatory requirements
and best practices.
We make Quality work for you with
comprehensive, end-to-end services.
Copyright 2011 Labtopia, Inc.

3. Copyright 2011 Labtopia, Inc.

4. “Their experts built our QA system from
the ground up working side-by-side with
our team. They do great work, but more
than that, they help us do our best
work.”
Technical Manager, Food Manufacturer
Copyright 2011 Labtopia, Inc.

5. What Can You Expect From Us?
WE WILL PROVIDE:
1. Simple and practical quality management tools
2. Flexible, customized support solutions
YOU WILL HAVE/BE:
1. Stable and consistent operations
2. Fully compliant
3. High performing
Copyright 2011 Labtopia, Inc.

6. Copyright 2011 Labtopia, Inc.

7. “EM2 Solutions offers a full service quality
management service. They have successfully
streamlined and upgraded both the ISO
9000:2000 and the ISO 17025:2005 quality
system for our organizations.”
Head of North America Regional Operations,
Commercial Lab
Copyright 2011 Labtopia, Inc.

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9. Our Focus?
Our client’s needs, budget, and
objectives throughout a project
lifecycle.
We deliver by the Golden Rule:
We’ve been in your shoes—what do we
expect?
Copyright 2011 Labtopia, Inc.

10. “Our stage one certification audit was a
breeze. Their support for our quality
system implementation was essential to
our success. Their project management
is truly top rate.”
President, Core Imaging Lab
Copyright 2011 Labtopia, Inc.

11. Implementing Lean
Getting ROI from your Quality Systems
Tools in the Laboratory
Copyright 2011 Labtopia, Inc.

12. We Support Your Quality Systems
Existing Standards Emerging Standards
• ISO 9001 • Environment
• ISO 17025 (NELAC)
• ISO 13485 • Food Safety &
HACCP Plans
• GMP/GLP
• Excipients and
• IPEC:PQG Nutraceuticals
Copyright 2011 Labtopia, Inc.

13. Don’t Reinvent the Wheel
EM2 designs a quality system around your
business processes--we build on what’s
working.
The end product is a robust quality system
and easy implementation
Copyright 2011 Labtopia, Inc.

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15. Need Training?
• Increase employee morale and provide value-added
skills to the workplace.
• Training programs
• Record-keeping
• Custom training classes
Ask about our upcoming
training classes.
Copyright 2011 Labtopia, Inc.

16. Copyright 2011 Labtopia, Inc.

17. Are You Thinking LEAN?
Lean can apply to Laboratories to
reduce costs and improve outcomes.
Are you getting all you can out of this
approach?
Copyright 2011 Labtopia, Inc.

18. “The work that their team is doing in our
company around Lean manufacturing applied
to our laboratory is top notch. We have
rolled it out in a couple of locations and have
lined up several more already.“
VP Regional Laboratory Operations, Commercial
Inspection Laboratory
Copyright 2011 Labtopia, Inc.

19. Copyright 2011 Labtopia, Inc.

20. We’re on Your Team for Excipient
Compliance
• Excipient Audits
• Type IV Drug Master Files
• IPEC:PQG Gap Assessments
• IPEA audit preparation assistance
• Excipient GMP Training
• USP™ Verified Pharmaceutical Ingredient
document preparation
• Excipient Information Protocol (EIP)
packages
Copyright 2011 Labtopia, Inc.

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22. "It has truly been a pleasure working with Labtopia.
They are knowledgeable and professional. They
have consistently delivered our projects on time and
on/under budget. It is easy to work with them--they
exemplify listening to the Voice of the Customer."
Quality Assurance Director
Chemical Company
Copyright 2011 Labtopia, Inc.

23. Implementing Lean
Getting ROI from your Quality Systems
Tools in the Laboratory
Copyright 2011 Labtopia, Inc.

24. Find Practical Solutions that Fit YOU
Our quality solutions bring your business, your
metrics, your objectives, and your processes
to the standard. We fill in the gaps only where
needed.
The result?
Minimal interruptions in day-to-day business &
Less up-keep after accreditation.
Copyright 2011 Labtopia, Inc.

25. Need Help with Food Safety System
Certification?
• We’ve Got You Covered.
 Gap Assessments
 Audits
 Compliance Support
 Training
 Custom Programs
Copyright 2011 Labtopia, Inc.

26. They customized our ISO quality systems to
meet the specific guidelines in our industry. It
was refreshing to work with really capable
people who understood us and our
environment.”
QA Manager, Petrochemical Company
Copyright 2011 Labtopia, Inc.

27. Don’t Know Where to Begin?
Don’t get overwhelmed by all that needs to be
done to meet a new standard or regulation.
Gap Assessment = QA Thermometer
Get your blueprint for building a successful
quality system today.
Copyright 2011 Labtopia, Inc.

28. How does a company get
certification?
Copyright 2011 Labtopia, Inc.

29. Ask About Our Risk-Based
Approach to Validation/Qualification
• Analytical Method Validation (GMP/GLP or ISO
17025)
• Software/Computer Validation including Excel
Spreadsheets (Legacy and New Systems)
• Equipment qualification (process
equipment, reactors, tanks, storage systems, etc.)
• Laboratory Instrument Qualification (IQ/OQ/PQ)
• Process Validation
Copyright 2011 Labtopia, Inc.

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31. Deep Industry Knowledge
• Petrochemical • Semiconductor
• Specialty Chemical • Medical Device
• Pharmaceutical • Commercial
• Personal Care Laboratories
• Food and • Research Laboratories
Neutraceuticals • Forensics
Copyright 2011 Labtopia, Inc.

32. They are skilled strategists, while being
operationally practical and add value to all
activities they perform. Needless to say, we
are delighted to have them as our quality
professional consultants.”
Head of North America Regional Operations,
Commercial Lab
Copyright 2011 Labtopia, Inc.

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34. Is There a GAP in your QA Team?
• Get on-site support with a
customized schedule
 Projects
 Independent QA unit
 temporary or Long-term QA
Copyright 2011 Labtopia, Inc.

35. Implementing Lean
Getting ROI from your Quality Systems
Tools in the Laboratory
Copyright 2011 Labtopia, Inc.

36. Facing Healthcare Regulations?
• From pharmaceuticals to personal care
products, we have you covered:
 Validation Protocols
 Drug Master Files
 Batch Record Reviews
 IPEC:PQG guidance
Copyright 2011 Labtopia, Inc.

37. What Kind of Audit Do You Need?
• Get a snapshot of the quality systems and insights
into how well the business operates.
• We can meet your audit needs:
 Internal
 Supplier
 GMP or GLP
 Gap Assessments
Copyright 2011 Labtopia, Inc.

38. Copyright 2011 Labtopia, Inc.