Safety
Quality
Delivery
Incorporated in 2007, No deviation is a patient-centric solution provider for the pharmaceutical industry.
We are experts in engineering consultancy, commissioning, qualification and validation services, and regulatory quality/compliance in Asia and Europe.
ABOUT US
Value Driven Purpose
We are a patient centric solution provider for the Pharma industry.
Every day, we go to work with the mission to promote a better quality of life by creating sustainable solutions for our people and partners.
Since 2007 those commitment have remained close to our hearts.
The Commitment to have a safer and healthier environment — That is what defines us
What We Do
Engineering
Front-End Engineering, Define URS, Process, HVAC, Process Automation
Commissioning - Qualification - Validation
From Strategy (Master Plans) Establishment to Protocol Generation & Test Execution. Paperless CQV.
Project Management
Define the Scope, Manage the Cost, Deliver the Quality, Integrate the Team.
GxP Compliance
GxP Risk Assessment, Compliance Remediation – from Gap Assessment to Remediation Execution, Audit Support & Audit.
No deviation offers personalised, focused solutions in Engineering Consultancy, and Regulatory Quality and Compliance, with a sharp focus on delivering value-adding Commissioning, Qualification and Validation services as leading experts in developing the lean CQV methodology.
We extend our offerings to GMP-certified software for environmental monitoring and contamination control, paperless validation, training and professional recruitment services. Since its inception in 2007, No deviation has gone on to provide an extensive range of solutions for the pharmaceutical, life sciences, food and beverage, and medical technology industries, enabling our clients to achieve long-term business goals.
We are highly committed to ensuring that your project’s unique needs are met right from design through to validation. We place keen attention on patient safety, process understanding, regulatory compliance and efficiency in the areas of safety, quality, delivery and cost.
As an early adopter of the ASTM E2500 paradigm, we have matured our risk-based qualification and validation capabilities. Based on your need and project maturity, we could deploy a full risk-based paperless validation with integrated commissioning and test plan or bring efficiency to your existing paper-based IQ, OQ execution.
We offer:
– Commissioning, Cleaning Validation, Process Validation
URS, DQ, FAT, SAT, IQ, OQ, PQ, Fit for Purpose, PPQ, EMPQ, Environmental Monitoring, CSV, GAMP 5, Continuous Verification
– Tech Transfer | Gap Assessment, Validation, Analytical Method Validation
– Process | API, Bio, Monoclonal, Vaccine, OSD, Aseptic, ATMP
With more than 50 in-house engineers, No deviation can define, design, procure, install, test, troubleshoot from simple equipment to complex critical systems.
– We can assist you with:
– Facility equipment utilities
– BMS / EMS / Process automation
– Improvement/Troubleshooting energy efficiency, Optimisation
– Design development and construction
– Quality plan and critical control points
– Operational excellence
– SOP development
Project Management
– OSHA (bizSafe Star) Certified
– PMI Certified
– Lean Thinking
No deviation has helped manufacturing sites to achieve, retain, regain cGMP compliance for diverse regulatory agencies ( FDA, EMA, PIC/S, HSA, CFDA…).
While addressing Gap to compliance is an urgent activity, developing quality culture is an essential enabler of quality assurance.
Our services include:
– CAPA/Remediation / Gap analysis / Audit / Audit
support / Supplier audit/ Training/Pharma
ceutical Quality System
– GMP Audit, Remediation
– QA, QC, QRM, Pharmaceutical Quality System (PQS)
Industries we work with
Pharmaceutical, Biopharma, Medical devices, Cell and gene, Advanced Therapeutic Medicinal Product (ATMP), Nutraceutical, Animal health, Cosmetics, Chemical engineering, Construction management, Equipment supplier, Staffing, Education (uni/school)
Additional services we can assist with
EMS Software
- License
- Installation
- Definition / Configuration
- Qualification
- Services Level Agreement
We provide these services through our partnership with Mirrhia.
Paperless Validation Software
- Process mapping
- Deployment
- Training (user/admin)
- Lifecycle management
We are partnered with Kneat Solutions to bring you paperless validation services. Through KneatGx, Kneat Solutions’ rich paperless validation platform, we can scale these processes across our clients’ various sites and provide ongoing support to their users.
Training
- CQV/ICHQ9
- PQS/ICHQ10/GMP
- HVAC/Utilities/ISO 14644/Annex1
- Sterile facilities
- Autoclave/SIP/Sterility assurance
- Equipment design
- GMP/GDP training
- HVAC & Facility | Design, Testing
- Clean Utilities |PQ, Remediation, Microbiology
- Audit preparation
- Audit Support Consultancy
Professional Recruitment Services
- Contingent worker provider
- Scope of service
- KPI-driven professional recruitment
We believe in a holistic approach to achieving a successful execution derived from the design thinking principles of Understand, Observe, Define and Implement, which takes its origin from Design Thinking. Whether as part of an integrated team, or overall scope management, we are confident of delivering effective results from tapping into our team’s vast knowledge and experience in the field.
Begin with the End in mind...
Where are we?
Company Main Driver
Company Main Driver
Safety
Quality
Delivery
Cost
Meet the Team
Pierre Winnepenninckx
CEO
Morgan O'Brien
GM, Nd Europe
JoonLeong Ng
Senior Manager
Shanshan Liu
Senior Manager
Our Mission and Vision
Mission
Promoting a better quality of life for our customers and employees through knowledge
development and challenge solving.
Vision
Creating sustainable solutions that will generate a safer, better and healthier way of life for the people we work with and the ones we work for.
Our Core Values
Transparency
We foster open dialogue and are truthful and provide the context for the decisions we make. We encourage participation and collaboration to build trust
Empathy
We put ourselves in your shoes and seek to understand your perspective and share your feelings
Integrity
We are passionate in our belief and in what we do, we say what we mean and mean what we say. We make realistic promises and follow through them
OUR PARTNERS
Our Clients
