OPPORTUNITIES

Product Security

In life science, patient safety is paramount.

Everyone understands the critical need to consistently meet high standards of product quality, security and safety to ensure continued license to operate.

The difficulty comes due to the fact life science organizations are also under extreme pressure to shorten lead times, reduce costs, and improve productivity. Change programs need to be viewed from a wider perspective to ensure they deliver added value.

Increased focus on Data Integrity

After a number of high-profile breaches in recent years, regulatory agencies have increased the scope of the meaning of data integrity. This has led to a significant increase in warning letters with data integrity citations.

Pharmaceutical companies are under pressure to ensure their computerized and paper-based systems meet strict regulatory requirements for the integrity of data over its entire life cycle.

It is major challenge. However, with the right approach, it also represents a key opportunity to realize operational improvements and generate additional sustainable value. Read more »

The dual goals of Serialization

Counterfeit medicines represent one of the greatest threats to the industry today.

Companies have both an ethical and legal responsibility to ensure their products reach the market in the correct way. Failure to do so can seriously impact a company’s reputation and global brand value.

Meeting new regulations relating to serialization is a company-wide challenge. But it is still only half the battle. Success requires that operational change also delivers additional business value.

 

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Insights & stories to share

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Meeting the Data Integrity challenge

Increased regulatory focus on data integrity is affecting the entire pharmaceutical industry. Data-generating systems and processes are, today, coming under intense scrutiny.

Electronic and paper-based data must meet stringent requirements over the entire data life cycle. For example, as defined by ALCOA – requiring data to be Attributable, Legible, Contemporaneous, Original and Accurate.

Companies need to ensure correct controls are in place and continually managed in order to reduce the risk of non-compliance. It is a complex issue affecting many functions within an organization, including operations, technology, lab, production, QA and IT.

PlantVision has taken a leading position within the area of data integrity. We can help to drive comprehensive data integrity initiatives, or provide specific services to support whatever stage your organization has reached.

  1) KNOWLEDGE – Basic and advanced training for those affected by data integrity.

  2) INSIGHT – Workshops to identify challenges/opportunities and carry out GAP analyses.

  3) INVENTORY – Inventories of all instruments and systems that impact data integrity.

  4) ASSESSMENT – Mapping out of risks and identifying where/how business value will be realized.

  5) DECISION – Planning project implementation and developing an implementation strategy.

  6) ACTIONS – Carrying out planned, prioritized actions, such as instrument/system qualification and validation, implementing new technical solutions, and developing SOPs, etc.

  7) LIFE CYCLE MANAGEMENT – Implementing routines and support processes to ensure continued compliance.

 

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Efficient implementation + improvement opportunities

Working with PlantVision brings with it additional benefits. We combine a holistic approach with in-depth expertise for integrating information systems, upgrading/implementing new technical solutions, and improving processes and working methods.

It means your data integrity project can simultaneously achieve operational improvements and generate additional sustainable business value.

  • Ensure GMP/GLP/GxP compliance relating to data integrity
  • Enhance quality systems and streamline processes
  • Improve production performance
  • Increase operational flexibility
  • Reduce costs, shorten lead times and minimize waste

LEARN MORE: Contact us today (email) »

LEARN MORE: Download our Data Integrity White Paper (Swedish only) »

LEARN MORE: Download our ‘cGMP Data Integrity’ information sheet (Swedish only) »

LEARN MORE: Download our ‘SMART Manufacturing (data integrity)’ information sheet (Swedish only) »

LEARN MORE: Free introductory INSIGHT Workshops »

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When it comes to GxP and data integrity, there are a number of issues your lab organization needs to focus on, including:

  • How do you ensure user identities are correctly used?
  • How do you ensure that all data is reported? How are atypical results handled? Are batches pre-tested?
  • How do you ensure that data is not lost or modified?
  • Do you save the same data in different places? (Primary data in relation to raw data?) How is data stored?
  • Is your data transfer process from lab instruments to LIMS properly validated?
  • Do you have permission routines? Who has access to results data on lab instruments/storage media?
  • Are your systems and software configured and validated for their intended purpose?
  • Are your standard routines specific enough? Are all routines followed?
  • How do you ensure researchers and QC personnel have the required training (in data integrity and/or the methods performed)?
  • What does your infrastructure look like for lab instruments and equipment?

Smart Lab Solutions

We have extensive experience with smart lab solutions, quality assurance and change management. We can support you with effective integration of lab processes, personnel and systems to meet GMP/GLP/GxP demands relating to data integrity while simultaneously:

  • Enhancing quality systems and streamlining processes
  • Increasing productivity
  • Improving operational flexibility
  • Reducing costs and shortening lead times

We support you at every stage

1) KNOWLEDGE – Basic and advanced training for those affected by data integrity.

2) INSIGHT – Workshops to identify, prioritize and explore challenges/opportunities.

3) INVENTORY – Inventories and gap analysis relating to instruments and systems that impact data integrity.

4) ASSESSMENT – Mapping out of information flows, quality systems and lab processes.

5) DECISION – Development of risk-based portfolio of prioritized, flexible and future-proof laboratory solutions that meet regulatory demands, enable data lifecycle management and minimize lab complexity.

6) ACTIONS – Lead, coordinate and carry out quality-related projects, and support change programs. Perform validation and qualification services, including risk assessment and requirements management.

7) LIFE CYCLE MANAGEMENT – Support for planning and implementation of efficient administration solutions.

 

LEARN MORE: Contact us today (email) »

LEARN MORE: Download our ‘Smart Lab – data integrity’ information sheet (Swedish only) »

LEARN MORE: Download our Data Integrity White Paper (Swedish only) »

LEARN MORE: Free introductory INSIGHT Workshops »

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Serialization

Counterfeit medicines are a growing problem on a global scale. It is an issue affecting the whole of the pharmaceutical industry as it concerns patient safety, business ethics and financial impact.

To combat the problem, regional and national authorities are implementing new regulatory requirements. Some are already in place, while the majority will come into force during the coming years.

Primarily, protection against counterfeit medicines covers four areas:

  • Serialization – All pharmaceutical packaging needs to be market with unique information (product-related information and a unique random serialization number).
  • Aggregation – The ability to read a single code on a transport unit in order to identify which products are included.
  • Tamper evident packaging – To show if the packaging is intact.
  • Verification – Uploading and checking serialization numbers on an information database, to ensure each unit is only sold/prescribed once.

To meet the new regulatory requirements, pharmaceutical companies face a major challenge. In most cases, implementing a ‘track & trace’ solution will require a company-wide change program, including:

  1. Indentifying requirements
  2. Anchoring change internally and ensuring stakeholder buy-in
  3. Selecting the right supplier and the right system solution
  4. Installing the new solution on the production line
  5. Establishing a data management solution
  6. Adapting routines to ensure the new system works in day-to-day operations
  7. Managing change, learning and improving

It is a complex journey affecting many different functions and levels within the organization. But it is also an opportunity to modernize and improve operational performance.

To be successful requires a holistic approach and an integrated strategy taking in the need for specialist expertise, for example, knowledge of applicable regulations, change management, system installation, validation activities, and administration of both automation and IT systems.

LEARN MORE: Read more in our white paper (Swedish only) »

 

 

Beyond the need to comply with current regulations, data integrity (or Good Information Practice) makes sound business sense.

For example, migrating batch release approval from a signed paper-based system to a fully electronic format offers clear advantages in terms of greater efficiency, easier information sharing, improved transparency and generating records in long term preservation-ready format.

Business benefits become even more pronounced for multisite and global companies. Often, each site operates as its own information island. There are no common processes or business rules for capturing, handling and securing data, and the opportunity to exploit global best practice is lost.

In this situation there are obvious performance and financial gains to be won by introducing a validated and simplified framework for company-wide data management.

However, the real business opportunity lies is in how you reach that goal.

Rather than a traditional waterfall approach, an agile risk-management approach leads to better performance and earlier ROI.

It allows you to prioritize and assign resources during a value-oriented planning phase. In turn, this enables quicker start up and more flexible delivery, with the ability to build in knowledge and learning as the project progresses.

  • Reduce risk by incremental launching
  • Reduce initial startup costs
  • Better liquidity, easier to finance
  • Reach break-even sooner by delivering value earlier and more frequently

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An agile risk-management approach reduces risk and provides an earlier return on investment.

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

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The primary goal of regulatory authorities is to protect public health. One of the ways they do this is to inspect regulated facilities to ensure they comply with regulations.

When one of our customers received a number of observations after an inspection by the Swedish Medical Products Agency, naturally, they wanted to react quickly.

However, as a small company with similar operations across three facilities, it was important to take a lean quality approach, i.e. to achieve optimal results using the least amount of resources possible.

Using a CAPA approach, PlantVision helped to investigate the root cause of problems and to define process goals. This enabled the current situation, as well as the future desired situation, to be mapped. Implementation, with specifically timed activities were then planned, carried out and validated efficiently.

The project delivered a clear description of a standardized way of working, with a formal road map for change and a common set of instructions for all three facilities. It also resulted in smarter operations!

  • Identification and correction of root cause
  • Improved processes and routines
  • Removal of unnecessary steps
  • Harmonized operations across facilities
  • Increased knowledge of GMP guidelines and regulations
  • Enabled a clearance from authorities – ‘License to Operate’

LEARN MORE: Find out more about our Quality Management services »

SPEAK TO AN EXPERT

Tony Forsberg
Senior Specialist Consultant, Quality Management
(Data Integrity)
Tel: +46 (0) 8 568 595 01
Email: tony.forsberg@plantvision.se
Connect: LinkedIn »
Linda Pell
Senior Consultant, Quality Management (Serialization)
Tel: +46 (0) 8 503 045 92
Email: linda.pell@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