Life Science Practice
“Companies in the life sciences industry will do very well in the decades to come, as long as they tackle the double challenge of increasing regulatory pressure and high efficiency required to outpace low-cost new entrants in the market. While new technologies like artificial intelligence, continuous manufacturing or virtual reality tools dominate the scene in public events, basic challenges like smart deviations and CAPA management, etc. remain an issue in everyday operations.“
Life Science Practice
“Companies in the life sciences industry will do very well in the decades to come, as long as they tackle the double challenge of increasing regulatory pressure and high efficiency required to outpace low-cost new entrants in the market. While new technologies like artificial intelligence, continuous manufacturing or virtual reality tools dominate the scene in public events, basic challenges like smart deviations and CAPA management, etc. remain an issue in everyday operations.“
What we deliver.
We are a challenging but empathic hands-on provider for compliant and evidence-based process efficiency, continuous QM-system transformation, and fast effective responses to audit findings and quality events. Through the proven uQualize+ approach we weld operational efficiency and GxP-compliance into two sides of the same coin.
Trust us – efficient compliance works!
(Below are some areas we serve in, followed by selected best practices)
What we deliver.
We are a challenging but empathic hands-on provider for compliant and evidence-based process efficiency, continuous QM-system transformation, and fast effective responses to audit findings and quality events. Through the proven uQualize+ approach we weld operational efficiency and GxP-compliance into two sides of the same coin.
Trust us – efficient compliance works!
(Below are some areas we serve in, followed by selected best practices)
End-2-End Site Transformation.
Depending on your business, your operations may be structured in the form of dedicated factories or mixed sites. Whichever approach is picked, it is imperative to ensure end-2-end optimization to eliminate the inefficiencies that destroy your bottom line.
Our highly skilled pool of experts swiftly weed out the bad stuff, and make your factory a much more structured, effective, and at the same time engaging workplace for your employees.
Our proprietary “3P” transformation approach systematically tackles the three dimensions, processes-procedures-people, in sync. This ensures sustainable transformation results. Additionally, our E2E service includes all different kinds of optimizations accompanying the value chain, such as: Sales forecasting & demand planning, intra(er) site logistics optimization or simply master data management.
End-2-End Site Transformation.
Depending on your business, your operations may be structured in the form of dedicated factories or mixed sites. Whichever approach is picked, it is imperative to ensure end-2-end optimization to eliminate the inefficiencies that destroy your bottom line.
Our highly skilled pool of experts swiftly weed out the bad stuff, and make your factory a much more structured, effective, and at the same time engaging workplace for your employees.
Our proprietary “3P” transformation approach systematically tackles the three dimensions, processes-procedures-people, in sync. This ensures sustainable transformation results. Additionally, our E2E service includes all different kinds of optimizations accompanying the value chain, such as: Sales forecasting & demand planning, intra(er) site logistics optimization or simply master data management.
Shared Service Optimization.
Ever thought “Why do we duplicate work at each production site”? You are not alone. Centralizing and carving out high-end services in one unit to save money and nerves is the name of the game in the industry.
The concerted approach of Global Business Services knits the idea of shared service centers into a consistent framework of customer value centered operations.
We accompany you on that road from conceptual design through implementation and operational go-live to robotic process automation (RPA) wherever you want to multiply your speed in service delivery. You call the shots, we get you the savings on the table.
Quality Emergency Remediation.
When quality emergencies happen, organizations can quickly go haywire. What is needed in such situations is a very clear-cut approach to systematically tackle the full bandwidth of the problem, understand the standards of compliance and existing gaps.
Key is here to “marry” compliance and efficiency experts in mixed teams – because this delivers your roadmap to the optimal response.
Precise monitoring of both progress and de-risking throughout the remediation program brings about the needed transparency that regulatory authorities expect from you. We will be glad to provide you with a cool head in the heat of this trip. From experience we know that there is a safe way out.
Quality Emergency Remediation.
When quality emergencies happen, organizations can quickly go haywire. What is needed in such situations is a very clear-cut approach to systematically tackle the full bandwidth of the problem, understand the standards of compliance and existing gaps.
Key is here to “marry” compliance and efficiency experts in mixed teams – because this delivers your roadmap to the optimal response.
Precise monitoring of both progress and de-risking throughout the remediation program brings about the needed transparency that regulatory authorities expect from you. We will be glad to provide you with a cool head in the heat of this trip. From experience we know that there is a safe way out.
Do you observe an inconvenient piling up of deviations and CAPAs? Do you feel that your laboratories could benefit from a more lean and efficient form of operation?
In fact, most manufacturers face these problems, even if they don’t talk about it. We have a very structured approach and toolkit to quickly get your labs in top shape and backlogs down to zero, together with your team.
It includes many small but highly relevant moves in how to i.e. optimize your complaints & deviations handling, ensure data integrity, speed up your registration process, simplifying the SOP landscape or the evergreen: a seamless product & batch record release! We compose your teams to trigger rapid and smart decision making and save you tons of money by straightforward getting the clutter out of the way.
Quality Excellence.
Quality Excellence.
Do you observe an inconvenient piling up of deviations and CAPAs? Do you feel that your laboratories could benefit from a more lean and efficient form of operation?
In fact, most manufacturers face these problems, even if they don’t talk about it. We have a very structured approach and toolkit to quickly get your labs in top shape and backlogs down to zero, together with your team.
It includes many small but highly relevant moves in how to i.e. optimize your complaints & deviations handling, ensure data integrity, speed up your registration process, simplifying the SOP landscape or the evergreen: a seamless product & batch record release! We compose your teams to trigger rapid and smart decision making and save you tons of money by straightforward getting the clutter out of the way.
GmP-Compliance Trainings.
Effective GmP-Training is highly critical in a VUCA world of quickly growing companies, evolving regulatory requirements, rapidly developing and changing staff compositions.
Our GmP Training features open courses at our ifss Academy or custom trainings. These range from more role oriented like “shift teams effectiveness, maximizing supervisor performance, or kata site leadership” to more tool oriented such as “using batch records and SOPs, equipment qualification (i.e. iQ/oQ), or investigators trainings & root cause analysis for deviations”.
GmP-Compliance Trainings.
Effective GmP-Training is highly critical in a VUCA world of quickly growing companies, evolving regulatory requirements, rapidly developing and changing staff compositions.
Our GmP Training features open courses at our ifss Academy or custom trainings. These range from more role oriented like “shift teams effectiveness, maximizing supervisor performance, or kata site leadership” to more tool oriented such as “using batch records and SOPs, equipment qualification (i.e. iQ/oQ), or investigators trainings & root cause analysis for deviations”.