No deviation offers personalised, customised 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 compliant 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 devices, 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.
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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.
– Commissioning, Qualification, Validation
- URS review & development
- FAT & SAT
- DQ, IQ, OQ
- PV | PPQ
- EMPQ | Cleanroom Qualification
- Cleaning Validation (CV)
- Sterilization Validation
- Continuous Verification
With a team of various experiences & knowledge, 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 | Environmental Monitoring System | Process Automation
– Troubleshooting | Process Optimisation | Energy Efficiency
– Design Development
– Operational Excellence
– SOP Development
– Project Management (OSHA (bizSafe Star) and PMI Certified)
– Tech Transfer | Gap Assessment, Validation, Analytical Method Validation
– Process | API, Bio, Vaccine, OSD, Aseptic, ATMP
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:
– Gap analysis (due-diligence) | Remediation | CAPA
– Mock Audit | Audit Support | Supplier Audit
– Pharmaceutical Quality System (PQS)
– CMC Support
Industries we work with
Pharmaceutical, Biopharma, Medical devices, 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
Environmental Monitoring System Software
- Definition / Configuration
- Services Level Agreement
We provide these services through our partnership with Mirrhia.
Paperless Validation Software
- Process mapping
- 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.
- Quality Risk Management (ICH Q9)
- Pharmaceutical Quality System (ICH Q10)
- GMP & GDP
- Inspection Readiness
- Sterile Facilities
- HVAC & Facility
- Clean Utilities
- Sterilisation (autoclave, SIP, sterility assurance)
Professional Recruitment Services
- Contingent worker provider
- 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.