Project Management Solutions for the Pharma Industry in Europe
Services
No deviation offers personalised, focused solutions in Engineering Consultancy, 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. Incorporated in 2007, No deviation has evolved 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 prioritise patient safety, process understanding, regulatory compliance and efficiency in the areas of safety, quality, delivery and cost.
Commissioning, Qualification, Validation
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.
By understanding the critical aspect of your process, No deviation will help you translate the process needs into the user requirement (URS) and functional specifications (FS), which will be a point of reference throughout the validation life cycle.
Those URS will be the source of your acceptance criteria for the systems qualification and process validation.
Starting with the design qualification (DQ) where the compliance of the design with GMP would be demonstrated and documented, as mandated in the EU GMP Annex 15.
From there, risks to the product critical quality attributes (CQA) would be assessed and we will define the testing strategy for facility and process equipment commissioning (FAT, SAT) to qualification (IQ, OQ) to process performance qualification and continuous verification.
At No deviation in Europe, 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
In addition to performing standalone CQV, we focus on tailoring the project delivery solution to match our clients’ needs. With a proven track record in defining and delivering Standalone and Integrated team approaches, No deviation are at the forefront of incorporating modern technology and tools that result in effective, compliant project delivery.
Our CQV expertise ranges across all disciplines with an existing network available to provide the client with a comprehensive foundation on which to build their team and deliver success.
Project Management
At No deviation, we have structured our project delivery model by fusing our on-site experience with knowledge from the likes of the Project Management Institute and the Lean Institute to provide a truly agile approach. The use of tools like Klaxoon, Monday.com, and Kneat among others, facilitate our Project Managers in achieving efficient and effective Communication with their Stakeholders.
Our Project Managers focus on ensuring the triple constraint of Scope, Cost and Schedule are balanced through each phase of the project by understanding the needs of the Project and Client as they evolve.
Additional services
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.
We also offer services in Quality & Compliance, and Training through the No deviation office in Singapore.
