OPPORTUNITIES

SMART Lab

A SMART Lab systematically creates and encourages innovations in the lab, which are enabled by talented people and integrated technology solutions.

It provides a basis for more efficient operations, managing quality, facilitating compliance and increasing productivity.

There are three key areas to consider:

  • Business process re-design – Replacing manual steps with automated processes that utilize configurable and harmonized workflows, allowing seamless integration of business processes and laboratory data.
  • Connectivity – LIMS, integrated systems and seamless data transfer, allowing shared access, transparency and faster decision support. Needs to be based on standardized, configurable solutions that reduce complexity and enable consistent information management.
  • Good Information Practice – Ensuring the integrity of data throughout its entire lifecycle and allowing access, extended usage and preservation of information. Replacing paper-based systems with electronic records, generated in long term preservation-ready formats.

Successful change requires that you start by knowing exactly what you want to achieve in terms of prioritized benefits and value goals. By taking a user story and case driven approach you also ensure usability and higher perceived value of the final solution.

  • Improve quality
  • Increase efficiency and productivity
  • Improve service levels and customer satisfaction
  • Facilitate faster and easier regulatory compliance
  • Improve employee satisfaction and motivation
  • Develop employee knowledge and skills
  • Achieve fast return on investment and sustainable business value

 

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Insights & stories to share

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SGS DNA Köping produces large biomolecules for customers in the Life Science sector. It’s a complex production process with many teams involved, data scattered in locally developed systems, and paper-based batch records manually signed multiple times.

Batch review and approval is a work-intensive process involving the QA team. A paper-based Certificate of Analysis is produced as a result of the release process.

Batch documentation and release needed improving without risking product quality.

CHALLENGE
Improve the batch documentation process in order to:

  1. Give all teams an overview of the customer order
  2. Support/lead operators through the production process
  3. Eliminate mistakes and transcription errors, thereby, minimizing the need to check data
  4. Give teams easy access to each other’s data to simplify decision making during the process
  5. Gain a better overview of batch data for QA
  6. Allow automated data transfer from instruments
  7. Shorten production lead time

SOLUTION
PlantVision and SGS DNA worked in close partnership to implement a new Electronic Batch Records solution based on SampleManager®.

An extension was added to SampleManager to provide a tool for registering customer orders.
Workflows and templates in SampleManager were configured to reflect SGS DNA’s production chain and documentation needs, as well as the Certificate of Analysis.

SampleManager standard functionality was used to provide a platform for label printing, instrument and stock handling and future integrations to other systems and instruments.

RESULTS

  • Standardized way of documenting – Same structure for all products and validated calculations, minimizing the need for checking.
  • Increased efficiency – Less time spent filling in and copying paper documents. Several users can view the same data simultaneously.
  • Data security – System controls which personnel are allowed to access or edit the data. Backups easily carried out by IT.
  • Data overview for QA – Faster review and approval process.

“We are pleased with the customized LIMS system and the support from PlantVision both during development project and drift phase. PlantVison has supported our project with skillful and engaged specialists.”
Bernadeta Losy, QA Manager, SGS DNA, Köping

LEARN MORE: Find out more about SampleManager »

 

cycle_timesEnsuring consistent product quality in process-based production is an ongoing task. A constant cycle of sampling, analysis and reporting is needed to feed results back into production in order to optimize process parameters.

For one of our customers, this procedure had become an area of concern.

Results from the various analysis instruments were registered manually in the existing lab information system. Test results were then entered into a report, printed out and passed to production in paper format.

The long lead time between each test result led to excessive variations in process parameters, resulting in variations in product quality. This was compounded by instances where incorrect results were delivered due to human error.

PlantVision was tasked with helping to shorten cycle times and ensure the accuracy of results.

Through careful analysis of the customer’s processes, including user case workshops, we were able to develop and implement a new solution. All lab instruments used for analysis were integrated with the lab information system, enabling data handling to be automated.

In turn, the lab system was also integrated with the production system, enabling automated reporting of test results directly to the production floor.

Benefits realized:

  • Significantly shorter lead times
  • Higher and more consistent quality in production
  • Elimination of manual errors associated with handling of test results
  • Time gains for lab personnel – able to carry out additional tasks

LEARN MORE: Find out more about value-driven change »

When you’re running a successful contract services business, things move fast. Operations grow, facilities expand, people and equipment are added.

Before you know it, your lab-based IT system has grown into something of a monster, demanding to be fed with ever more time and resources.

This was the situation experienced by one of our customers who faced a mounting list of challenges. The IT infrastructure was not qualified and instruments were not validated. Instrument systems and lab PCs were running on a wide range operating systems. Getting disaster & recovery support was expensive and complicated. Result files were being stored locally and needed manual backup.

What was needed was a new IT solution, adapted for a complex environment. As well as resolving the current issues it also needed to be able to support the company’s continued success.

Drawing on a combination of project excellence, experience of similar complex IT environments, technical skills and QA expertise, we were able to help the customer reclaim control of their lab IT.

  • A qualified IT infrastructure providing a basis for validating systems.
  • Lab PCs with different operating systems able to coexist in an office environment.
  • Secure communications between lab and office systems.
  • Secure remote and off-site access.
  • Automated storing and backup of electronic raw data.
  • Possibility to integrate LIMS and other systems that use instrument data.
  • Enabling flexibility and system evolution to meet growing business needs

LEARN MORE: Download our information sheet » SMART LAB INFRASTRUCTURE – Greater lab digitization boosts lab performance

LEARN MORE: Find out more about value-driven change »

One company – with different labs – in different countries – using different processes – and different systems. Harmonization is needed. And the larger the organization, the larger the potential performance and business benefits harmonization will bring.

Let’s take the example of an established global pharmaceutical company.

Operations are carried out in an environment of mergers, acquisitions and continual organizational and infrastructure changes. There’s a lack of standardization, and high demands on productivity due to an increasing number of drug development projects.

The result is a culture of “My process, my data.” Local systems have become highly customized, there’s little systematic integration of information, limited degrees of automation and very little assimilation between labs.

What should be done?

There are a number of integrated steps the organization could take to generate greater sustainable value.

  • Start by creating a vision; “To capture, structure and secure instrument and laboratory data in ONE system, according to ONE process, using ONE set of business rules.”
  • Define a systematic (yet flexible) roadmap for change. Harmonization is likely to require at least 3-5 years.
  • Consolidate systems by adopting a principle of buy not build.
  • Create a dedicated enabling service organization supported by IS/IT
  • Establish long-term relationships with external vendors and CRO/CMOs

In addition to realizing a wide range of direct benefits associated with usability, quality and cost avoidance, this approach will also deliver some powerful business level advantages:

  • Effective company-wide utilization of informatics solution investments
  • Effective business development utilizing laboratory information
  • A foundation for achieving continuous improvement of all lab-based operations

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LEARN MORE: Find out more about value-driven change »

SPEAK TO AN EXPERT

Johan Granérus
Business Area Manager, Laboratory Information
Tel: +46 (0) 31 380 2114
Email: johan.granerus@plantvision.se
Connect: LinkedIn »
Anders Jernberg
Specialist Consultant, Laboratory Information
Tel: +46 (0) 523 488 46
Email: anders.jernberg@plantvision.se
Connect: LinkedIn »

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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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