Expertise.
Laboratory Operations.
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In general, any type of laboratory plays an essential role in chemical, pharmaceutical or healthcare companies. After the discovery of APIs or the selection of APIs from different API collections, design, route finding and chemical synthesis take place. Subsequently, multi-gram scale reactions are performed in process optimisation laboratories to prepare the synthetic route for pilot and mass production up to the first validation batches.
Thus, research and development, process transfer as well as quality control or diagnostic laboratories represent important functions within the whole pharmaceutical and healthcare industry. Especially quality control laboratories are a key institution within the value chain and make the difference of either a robust or vulnerable supply chain. Most state of the art supply chains consist of highly optimized, digitally enabled and partly automated quality control laboratories making the processes as resilient and transparent as possible.
Diagnostic laboratories also benefit from these advanced tools and processes and play a crucial role in daily life.
A prominent example is the COVID-19 pandemic, one of the most difficult global crises, which has shown that the demand for rapid test results through a laboratory landscape that is fully aligned with processes is increasing.
Transparency.
Transparency in process and project planning, sample flow and key data.
Reduction.
Reduction of time-consuming manual effort via digitally enabled tools.
Efficiency.
Efficiency across the lab process landscape with lean and operational excellence management.
Would you like to optimise your Laboratory Operations?
Digitally enabled and Process fine-tuned Laboratories.
Our approach for the laboratory landscape 2030plus
Multiple digital and automated technologies have been developed during recent years representing suitable and very attractive opportunities to initiate the change in pharmaceutical laboratories. Most improvement levers are already up to one hundred percent available and fully cost-effective.
Full system integration, GMP-compliant electronic laboratory notebooks, visual performance management via digital dashboards, transparent KPI tracking or SOPs via smart glasses or tablets are already available. Furthermore, advanced analytics performed by data scientists or data engineers enable a more efficient lab resource planning and scheduling.
Real-time trending, problem solving supported by AI and an automated inventory management are also ready for introduction and cause various benefits.
Our Quick Check.
How Entourage supports customers, more efficiency and transparency in laboratory operations.
- Request of key data, information, innovation level and stakeholder insights
- Review of shared data and documents for preparation
- Organisation of a scoping workshop with project sponsor, lead and core team
- Preparation of a cross-functional interview schedule
- Conduction of the on-site scoping workshop
Scoping Workshop
- On-site visit of all relevant sites
- Conduction of stakeholder interviews
- Identification of the strengths and weaknesses of each laboratory
- Mapping of the processes, tools, systems and capabilities of each QC laboratory
- Comparison of lab innovation level via industry best practice benchmarking
- Analysis of the interfaces to R&D, QA and production
- Gap and maturity assessment of all laboratories
- Recommendation of appropriate improvement levers
- Development of a client-specific lean lab concept with defined work packages
- Prioritization of tasks per work package
- Collecting feedback on the way we have worked so far
- Presentation of results within the project team
QuickCheck Report
- Elaboration of a detailed project plan for the design phase
- Selection of cross-functional teams per work package
- Definition of a pragmatic communication structure
- Introduction of a joint PMO for project steering and oversight
- Organisation of a multi-site kick-off workshop
Possible work packages
In the conception and implementation of a lean laboratory landscape.
- Project management.
- Efficiency and Transparency of the QC Process.
- QC Tools, Systems and Technologies.
- Stakeholder and Change Management.
- QC lab, IT infrastructure, CSV and DI.
- Training and Coaching.
- Organisation Setup and Design.
- Recruitment Strategy and On-boarding.
Laboratory experts
Get to know our laboratory experts.
Services
Our services in Laboratory Operations.
Transparency.
- Digital dashboard prototypes and support in advanced analytics
- Transparent lab performance management and defined key performance indicators
- Real-time tracking of sample throughput and equipment utilization
- Improve visibility on sample arrival or forecast, including sample leveling strategy
Reduction.
- Time efficient documentation and reporting via digital tools and standard templates
- Reduced paper-based documentation through GMP-compliant electronic laboratory journals
- Decreased waste of personnel resources and equipment capacities via lean management
Efficiency.
- Optimized process sequences, standard work, route planning and physical sample flow
- Neutral, 3rd party benchmarking of the laboratory’s innovation and maturity level
- Smooth cross-functional collaboration and joint process understanding across all interfaces
- Sustainable hiring support and on-boarding of laboratory specialists
Services
Our services in Laboratory Operations.
Transparency.
- Digital dashboard prototypes and support in advanced analytics
- Transparent lab performance management and defined key performance indicators
- Real-time tracking of sample throughput and equipment utilization
- Improve visibility on sample arrival or forecast, including sample leveling strategy
Reduction.
- Time efficient documentation and reporting via digital tools and standard templates
- Reduced paper-based documentation through GMP-compliant electronic laboratory journals
- Decreased waste of personnel resources and equipment capacities via lean management
Efficiency.
- Optimized process sequences, standard work, route planning and physical sample flow
- Neutral, 3rd party benchmarking of the laboratory’s innovation and maturity level
- Smooth cross-functional collaboration and joint process understanding across all interfaces
- Sustainable hiring support and on-boarding of laboratory specialists
Efficiency.
- Optimized process sequences, standard work, route planning and physical sample flow
- Neutral, 3rd party benchmarking of the laboratory’s innovation and maturity level
- Smooth cross-functional collaboration and joint process understanding across all interfaces
- Sustainable hiring support and on-boarding of laboratory specialists
Services
Our services in Laboratory Operations.
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Services
Our services in Laboratory Operations.
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Case Studies
Our Case Studies in Laboratory Operations.
Maturity assessment and optimisation of the laboratory process landscape.
The challenge. The preliminary goal was a short industry best practice benchmark analysis of the QC processes and tools with a focus on transparency and efficiency. The status quo diagnosis revealed an inadequate laboratory infrastructure (fume cupboards, office space, equipment, route planning) as well as a lack of interfaces between production and research and development. In addition, time-consuming documentation was done in paper-based journals and the control of laboratory utilisation and throughput was manually compiled from various data sources. A visual laboratory performance management was not available and it was not possible to plan the utilisation due to the lack of interface communication and the lack of granularity of the sample forecast.- Introduction of a new laboratory structure with clear roles and responsibilities
- Restructuring of the organisational set-up within the QC with autonomous, self-organised working groups
- Training staff in new technologies and lean philosophies
- Revision of the process landscape incl. sample receipt, physical sample flow, capacities and route planning
- Definition of suitable KPIs and design of digital dashboard prototypes
- Promoting interface collaboration through Joint Understanding Workshops
25%
Improving productivity or sample throughputMind-Set Change
and enjoyment of continuous optimisation across all quality control interfaces45%
Reduction of the effort for documentation and controlIncrease QC productivity in 9 months
Case Studies
Our Case Studies in Laboratory Operations.
Blog
Recent Blog Articles.
What collaboration with Entourage is all about.
- Unique combination of Project Consulting and Strategy Consulting as Hybrid Consulting
- In-depth expertise in pharma, biotech, medical technology and IVD
- Empathic approach with hands-on mentality
- Precise and goal-oriented way of working
- Sustainable success through continuous support
We specialize in life sciences.
Experience how Entourage's expertise creates concrete benefits for your company.
Medical technology.
Medical devices / IVD.
- Regulatory Affairs
- Clinical Affairs
- Quality
- Research & Development
- Software as a device
Pharmaceutical products.
Pharma / Biotech.
- Manufacturing Science and Technology (MS&T)
- Quality Management
- Medical. Clinical. Pharmacovigilance.
- Regulatory Affairs
- Research & Development
How we support you with MDR Consulting Services.
- Identification of the new requirements for your products (e.g. through reclassification)
- Strategic advice on a roadmap for the compliance of your products after MDE
- Support with labelling and introduction/maintenance of the UDI
- Planning and preparation of approval documentation
- Supply
- Support a strategic plan for the submission of dossiers under MDR
- Maintenance of product dossiers for sustainable compliance
- Intensive stocktaking and analyses at different levels of depth
- Identification of pain points
- Creation of a strategy to close gaps quickly
- Documentation control and creation over the life cycle of your products from design to production and approval, to post-market surveillance and post-market clinical follow-up (PMCF).
- Risk-based assurance of the quality of your products with the help of pragmatic and individual solutions
- Validation and qualification of your processes and systems
- Strategic planning of clinical investigations and clinical follow-up, tailored to your product class
- Preparation and support of the clinical documentation required under MDR
