Driving operational excellence in
LIFE SCIENCE

Smarter operations – Improved performance – Sustainable value

CHALLENGES


EFFICIENCY

Organizations are under increasing pressure to simultaneously increase productivity and reduce waste.

Life Science companies operate in a competitive global marketplace being intensified by expiring patents, new product introductions, price pressure from generics and concern over rising healthcare expenditure.

Modernization combined with digital transformation is one of the biggest challenges today. Better use of data and analytics is needed to drive a continual cycle of improvement that improves production capacity, increases availability, reduces downtime, improves processes and decision making, and eliminates waste.

FLEXIBILITY

Stability and meeting production targets are no longer enough. Time to market is critical and companies have to be able to react and adapt quickly.

The ability to respond quickly to opportunities and challenges is now a key success factor within all areas of Life Science activities.

Whether driven by market dynamics, company strategy or short term targets, management are demanding greater flexibility from operations. An agile approach is needed to meet production changes (e.g. product value, potency and volumes), implement new technologies, increase delivery precision, and shorten time to market.

QUALITY

Quality systems need to be established and managed in a way that meets requirements and strengthens operations.

Life Science companies operate within a stringent regulatory framework, which is subject to constant change and is strictly controlled by different national and regional authorities.

It is a complex environment where patient safety is paramount. Quality systems need to support GxP guidelines, ensure compliance with regulations and facilitate regulatory inspections. Being successful requires an integrated and pragmatic risk-management approach that strengthens operations and optimizes the use of resources.

CHANGE

Around 80% of change programs fail to meet expectations. Ensuring change delivers sustainable value is today’s key business challenge.

Meeting the combined challenge of efficiency, flexibility and quality requires change in some form. Implementing change, however, is only half the battle. Ensuring it results in greater sustainable value is the real challenge.

Change is almost never a straight journey from A to B. Succeeding with value-driven change requires taking a persistent, stepwise journey along a winding path. It requires insight and an integrated, flexible approach that combines people, processes and technology.

ADDING VALUE


Welcome to the Life Science market’s most complete and qualified offering.
CONSULTING, SERVICES & SOLUTIONS.


  • Connector.

    PlantVision is Scandinavia’s leading consultancy for realizing operational improvement. We support pharmaceutical, biotech and medical device companies with a broad range of services and solutions, covering research, development, manufacturing and production lifecycle management.

  • Connector.

    We specialize in helping customers to realize greater value from operational change. We combine business insight with specialist expertise and project excellence to help customers reach the market sooner, operate more efficiently, and generate greater sustainable value.

CUSTOMER STORIES

Visualizing performance at AstraZeneca

AstraZeneca’s tablet manufacturing plant in Södertälje, Sweden is one of the largest in the world, responsible for the global supply of six of the company’s top ten products.

Data used to be collected by hand from the various production units and manually entered into spreadsheets. The information could only be interpreted at a high level since handling the large data volumes required for more in depth analysis proved to be unmanageable.

To take full advantage of the vast amounts of production data available in order to improve production performance, drive lean initiatives and enable faster decision support.
PlantVision helped AstraZeneca to develop, implement and optimize a real-time performance management and decision support solution (based on PlantVision’s PlantPerformance).

  • The system collects and logs production-related data from over 200 diverse individual machine units and more than 100 analysis instruments.
  • Managers, operators, lean coordinators, and maintenance staff all have access to the same comprehensive central database of real-time and historical data.
  • Results are visualized in a user-friendly graphical format making them quick and easy to understand and use. Information can be viewed on any level, making it possible to drill down from an overview level to uncover root cause with a few simple clicks.
  • Each production unit uses large screen LCD monitors to provide employees with visual, real-time feed-back about production status and events.
  • Capacity utilization improved > 10% within first 12 months of operation.
  • Number of machines across production lines reduced without affecting production volumes.
  • Reduced machine support and maintenance requirements.
  • Almost 100% of production time is now logged (including the reasons for stoppages where they occur). Day-to-day productivity has improved as problems are now dealt with as soon as they arise.
  • Ability to identify trends and follow up improvement programs. Can identify areas of best practice and implement them across all production units.
Visual performance
Smarter monitoring

Smarter monitoring at Galderma

Galderma’s site in Uppsala, Sweden (previously Q-Med) is the company’s Global Aesthetic Center of Excellence with nearly 450 employees carrying out world-class research and manufacturing.

A key aspect of compliance when manufacturing medical devices is monitoring the production environment – temperature, humidity and air pressure, etc.

The company was operating independent facility monitoring systems (FMS) for each production unit, which was time consuming and complicated. Data needed collecting from each unit and compiling manually.

The company had built a new clean room production unit and wanted an expandable and future-proof FMS solution that could boost efficiency and eliminate information islands.
PlantVision helped to develop, implement and optimize an integrated solution combining process automation, information management and quality assurance.

  • The fully automated solution logs GxP data from sensor readings, including high and low value alarms. It handles approx. 2,000 measurement points across different production lines, plants and buildings.
  • It includes a process data overview system for the presentation, reporting and long-term archiving of critical GxP data.
  • All data is stored centrally. A web-based interface means all users can access the information from their own PC.
  • Development and implementation was carried out under PlantVision’s stringent quality management system helping to ensure a smooth validation process.
  • Significant time savings as users can now monitor all production units in real time from their own PC.
  • Operators, process engineers, quality assurance and technical services all access and share the same real-time information.
  • Automated and ad hoc reports can be quickly and easily generated making review and approval processes more efficient.
  • The standardized approach simplifies administration and upgrading.
  • The system facilitates regulatory inspections as the same underlying platform is used for all production units.
  • Provides an expandable platform capable of incorporating new and existing production units.

Reusable quality at Sicor Biotech

Sicor Biotech UAB is a biotech pharmaceutical company that develops and produces recombinant biopharmaceuticals using advanced science and production technologies.

The company needed to validate a large number of electronic spreadsheets used as calculation templates at its production facility in Vilnius, Lithuania.

Validation is a mandatory requirement of cGMP. Any computerized system that affects patient safety, product quality or data integrity must be appropriately validated.

To develop and implement a pragmatic strategy that would enable validation to be carried out as efficiently as possible in full compliance with regulations.
Based on Sicor Biotech’s Quality Management System and “GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems,” PlantVision helped to develop a modular and reusable concept for the validation of the electronic spreadsheets. Validation was carried out in two phases.

An initial electronic spreadsheet of medium complexity was validated. During the process, specific but reusable documents were developed, e.g. combined User Requirement Specification and Functional Specification (URFS), Risk Assessment, Qualification Protocol, Final Report, and a common Validation Plan.

The lessons learned were used to optimize working methods. The remaining electronic spreadsheets were then validated in parallel, reusing the templates and principles established during phase one.

  • By establishing close cooperation, PlantVision gained a thorough understanding of Sicor Biotech’s internal processes, enabling the project to be planned very effectively.
  • Using a modular, risk-based and reusable validation concept enabled the company’s cGMP-critical electronic spreadsheets to be validated extremely quickly and cost effectively.
  • Carrying out risk assessment analyses for each electronic spreadsheet meant qualification tests could focus on the functions representing the most risk. This enabled validation to be carried out in a flexible, focused and scalable manner.
Reusable quality

CUSTOMER STORIES


Placeholder

Visualizing performance at AstraZeneca

AstraZeneca’s tablet manufacturing plant in Södertälje, Sweden is one of the largest in the world, responsible for the global supply of six of the company’s top ten products.

Data used to be collected by hand from the various production units and manually entered into spreadsheets. The information could only be interpreted at a high level since handling the large data volumes required for more in depth analysis proved to be unmanageable.

To take full advantage of the vast amounts of production data available in order to improve production performance, drive lean initiatives and enable faster decision support.
PlantVision helped AstraZeneca to develop, implement and optimize a real-time performance management and decision support solution (based on PlantVision’s PlantPerformance).

  • The system collects and logs production-related data from over 200 diverse individual machine units and more than 100 analysis instruments.
  • Managers, operators, lean coordinators, and maintenance staff all have access to the same comprehensive central database of real-time and historical data.
  • Results are visualized in a user-friendly graphical format making them quick and easy to understand and use. Information can be viewed on any level, making it possible to drill down from an overview level to uncover root cause with a few simple clicks.
  • Each production unit uses large screen LCD monitors to provide employees with visual, real-time feed-back about production status and events.
  • Capacity utilization improved > 10% within first 12 months of operation.
  • Number of machines across production lines reduced without affecting production volumes.
  • Reduced machine support and maintenance requirements.
  • Almost 100% of production time is now logged (including the reasons for stoppages where they occur). Day-to-day productivity has improved as problems are now dealt with as soon as they arise.
  • Ability to identify trends and follow up improvement programs. Can identify areas of best practice and implement them across all production units.

Placeholder

Smarter monitoring at Galderma

Galderma’s site in Uppsala, Sweden (previously Q-Med) is the company’s Global Aesthetic Center of Excellence with nearly 450 employees carrying out world-class research and manufacturing.

A key aspect of compliance when manufacturing medical devices is monitoring the production environment – temperature, humidity and air pressure, etc.

The company was operating independent facility monitoring systems (FMS) for each production unit, which was time consuming and complicated. Data needed collecting from each unit and compiling manually.

The company had built a new clean room production unit and wanted an expandable and future-proof FMS solution that could boost efficiency and eliminate information islands.
PlantVision helped to develop, implement and optimize an integrated solution combining process automation, information management and quality assurance.

  • The fully automated solution logs GxP data from sensor readings, including high and low value alarms. It handles approx. 2,000 measurement points across different production lines, plants and buildings.
  • It includes a process data overview system for the presentation, reporting and long-term archiving of critical GxP data.
  • All data is stored centrally. A web-based interface means all users can access the information from their own PC.
  • Development and implementation was carried out under PlantVision’s stringent quality management system helping to ensure a smooth validation process.
  • Significant time savings as users can now monitor all production units in real time from their own PC.
  • Operators, process engineers, quality assurance and technical services all access and share the same real-time information.
  • Automated and ad hoc reports can be quickly and easily generated making review and approval processes more efficient.
  • The standardized approach simplifies administration and upgrading.
  • The system facilitates regulatory inspections as the same underlying platform is used for all production units.
  • Provides an expandable platform capable of incorporating new and existing production units.

Placeholder

Reusable quality at
Sicor Biotech

Sicor Biotech UAB is a biotech pharmaceutical company that develops and produces recombinant biopharmaceuticals using advanced science and production technologies.

The company needed to validate a large number of electronic spreadsheets used as calculation templates at its production facility in Vilnius, Lithuania.

Validation is a mandatory requirement of cGMP. Any computerized system that affects patient safety, product quality or data integrity must be appropriately validated.

To develop and implement a pragmatic strategy that would enable validation to be carried out as efficiently as possible in full compliance with regulations.
Based on Sicor Biotech’s Quality Management System and “GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems,” PlantVision helped to develop a modular and reusable concept for the validation of the electronic spreadsheets. Validation was carried out in two phases.

An initial electronic spreadsheet of medium complexity was validated. During the process, specific but reusable documents were developed, e.g. combined User Requirement Specification and Functional Specification (URFS), Risk Assessment, Qualification Protocol, Final Report, and a common Validation Plan.

The lessons learned were used to optimize working methods. The remaining electronic spreadsheets were then validated in parallel, reusing the templates and principles established during phase one.

  • By establishing close cooperation, PlantVision gained a thorough understanding of Sicor Biotech’s internal processes, enabling the project to be planned very effectively.
  • Using a modular, risk-based and reusable validation concept enabled the company’s cGMP-critical electronic spreadsheets to be validated extremely quickly and cost effectively.
  • Carrying out risk assessment analyses for each electronic spreadsheet meant qualification tests could focus on the functions representing the most risk. This enabled validation to be carried out in a flexible, focused and scalable manner.

OPPORTUNITIES


SMART MANUFACTURING

Combining digitization, process integration and the role of individuals.

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OPERATIONAL INTELLIGENCE

Drive continuous improvement by empowering employees.

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QUALITY & REGULATORY EXPERTISE

Experience and expertise ensure compliance with added value.

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MANAGING CHANGE

Value-driven change propelled by insight and project excellence.

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PROCESS ENGINEERING

Design and implement effective production processes using an agile approach.

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SMART LAB

Combine automation, business processes and good information practice.

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PRODUCT SECURITY

Ensure data integrity and serialization projects deliver business value.

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MARKET ACCESS

Effective tech-transfer and regulatory expertise reduce time-to-market.

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HOW WE WORK


  • Connector.

    DEVELOP

    Typically, we are involved from an early stage, helping you to analyze the situation, define challenges and opportunities, and create a successful future vision. To achieve this, we take a holistic approach, encompassing people, processes and the entire life cycle of solutions. We support business case development, carry out pre-studies, and develop concept solutions and prototypes as necessary. We also make sure change can be effectively managed throughout all project phases so that your solution generates maximum sustainable value.

  • Connector.

    EXECUTE

    We take an agile approach to project deliver, applying our extensive experience in the areas of IT infrastructure, systems integration, engineering, quality assurance and project management. It means we can efficiently deliver fit-for-purpose concepts and solutions even in the most complex, regulated environments. Experienced project managers can take responsibility for an entire project, while technical lead engineers, technical experts and sub-project consultants provide specialized capabilities as needed. We also make sure your personnel are properly trained and motivated, so there is a smooth transition to the operational phase.

  • Connector.

    IMPROVE

    Our value-lifecycle approach ensures your solution delivers a maximum return on investment. We help you to develop strategies for business development, service management and change management, as well as provide hands-on expertise and ongoing support. In-built quality platforms mean you can be confident that solutions can evolve and are easily upgradable to meet future operational requirements. The aim is to ensure the long-term reliability of your solution while continuously improving working methods and processes to support a value-adding company culture.

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About PlantVision

PlantVision is Scandinavia’s leading consultancy for realizing operational improvement.

We offer an integrated approach, broad experience across industries, and in depth solutions expertise. Since starting in 1999, we have delivered value in thousands of projects across Scandinavia and around the world.

We support customers at every stage with professional services and a sound quality approach – from idea, analysis and planning, to implementation, training and long-term support. We also offer the market’s most complete range of close-to-production information solutions.

PlantVision is the ideal partner for companies that want to generate maximum sustainable value from business change.

www.plantvision.se

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