NEWS

DID YOU KNOW? 17th May 2022

Did you know? prime4services informs about GAMP D-A-CH Information

Aim and Purpose

  • GAMP D-A-CH is a neutral platform for the exchange of information in the field of the life science industry, suppliers and authorities in the German-speaking countries Germany (D), Austria (A) and Switzerland (CH). Communication language is German.
  • The aim is to strengthen the acceptance, awareness and application of the current GAMP Guide and to contribute to further developments and the success of the GAMP Guide.

GAMP D-A-CH activities (forums, working groups, conferences)

  • GAMP D-A-CH organizes two one-day forums per year for the exchange of experiences and for the presentation of current new topics in the field of computer system validation. The meeting location changes, the member companies (sponsors) provide premises.
  • In special working groups (so-called Special Interest Groups – SIGs), which meet more often per year, topics are developed which are published in GAMP publications, VDI/VDE guidelines and journal articles.
  • In cooperation with 4 organizations (ISPE D/A/CH, VDI/VDE-GMA, APV and Concept Heidelberg), GAMP D-A-CH organizes an annual conference on computer system validation, which is usually held in early December.

SIGs or working groups (actual status)

  • R&D and Clinical Systems
  • Validation of M2M interfaces
  • Supplier auditing
  • Application of GAMP principles to the manufacture of medical devices and products
  • Audit trail review
  • Data protection/IT security in the GxP environment
  • Blockchain in the GxP environment
  • AI in the GxP environment

Annual Conferences

  • GAMP D-A-CH is a local CoP (Community of Practice) of ISPE D/A/CH and a technical committee of the VDI/VDE-Gesellschaft Mess- und Automatisierungstechnik (GMA).
  • It is managed by a mixed steering committee, where at least four members shall be from life science companies, one from authorities and the rest from supplier companies, consultancies or universities.
  • The steering committee will be led by a leader and a deputy leader, who will ensure the integration into the international GAMP organization (GAMP-CoP of ISPE) and cooperate with the offices of ISPE-D/A/CH and VDI/VDE-GMA.
  • The secretariat tasks are covered by the VDI/VDE-GMA.

Membership in GAMP-D-A-CH

  • Those interested in joining GAMP D-A-CH should be from the IT/Automation/Life Science professional environment.
  • To become a member, you must register in the website.
  • Full name, company name and address, including phone number and email address has to be provided.
  • An indication shall be give whether the company is a life science company, a manufacturing company, a consulting company, a government agency, or a university.
  • Once registered, the new member will receive the associated invitation approximately four weeks before the next meeting.

For more information please visit the following link: https://www.vdi.de/tg-fachgesellschaften/vdi-gesellschaft-mess-und-automatisierungstechnik/engineering-und-betrieb-automatisierter-anlagen/gamp-d-a-c-h-forum

 

DID YOU KNOW? 10th May 2022

Did you know? prime4services informs about GAMP Open-Source Software (OSS)

GAMP Considerations when relying on Open-Source Software

An ISPE article aims to refresh information on open-source software (OSS) within regulated computerized systems that was first discussed in 2010 in the ‘Pharmaceutical Engineering’ Magazine

The article explains the importance of understanding the benefits and risks organizations face when relying on OSS from a GAMP®5 perspective

Changes since 2010

While a lot has recently changed in IT, the principles of GAMP mentioned in the 2010 article is still valid for most companies that leverage OSS.

However, there have been significant developments in the way organizations develop and maintain OSS.

The collaborative development process and the accessibility to access the source code to study, use, or modify must be considered to meet regulatory requirements.

Risks and Considerations for relying on OSS in regulated environments

  • Understand what software you are relying on
  • Create an OSS catalog
  • Have confidence in the size and sustainability of the OSS community
  • Look for the use of development standards and good documentation
  • Know what version you are using
  • Understand the governance model
  • Keep up to date
  • Participation

DID YOU KNOW? 3rd May 2022

Did you know? prime4services informs about  Quality Agreements for software as a service (SAAS) Solutions

Quality Agreements for SAAS Solutions intended for GxP Use

  • ISPE has posted an article in ‘Pharmaceutical Engineering’ about an approach how to create Quality Agreements for SAAS Solutions in GxP environments
  • As adoption of cloud technology continues to increase across the life sciences industry, there is a strong need to establish a standardized pragmatic approach for ensuring the quality of software applications used in support of GxP areas
  • The article focuses on the application level and the growing use of software as a service (SaaS) within the life sciences industry

SAAS Application Quality Pillars

  • Many elements contribute to the overall quality of a SaaS solution.
    These elements may be grouped into the following key pillars:

    • Infrastructure quality
    • Software quality
    • Service quality

Recommended Quality Agreement Contents

  • The quality agreement serves as a binding document which lists the actions and commitments that the SaaS provider agrees to accept to meet the industry standards and quality requirements deemed relevant by the regulated company
  • The regulated company will need to ensure the SaaS provider can fulfill the quality requirements, and both parties must agree on the responsibilities for meeting these requirements

Considerations and recommended controls

  • Roles and Responsibilities
  • Quality System
  • Standard Operating Procedures
  • Software Development Life Cycle
  • Security
  • Data Integrity and Record Management
  • Software Release Cycle
  • Testing
  • Documentation
  • Change Control
  • Service Support and Communications
  • Monitoring
  • Service/Application Review
  • Supplier Assessment
  • System Retirement/Contract Termination

DID YOU KNOW? 26th April 2022

Did you know? prime4services informs about EudraLex Volume 4!- Summary

EudraLex – Summary 

The Chapters of Part I includes :

  • Basic requirements
  • Quality Management
  • Each chapter includes:
  • Quality management objectives
  • Sufficient manufacturers information

Part II is established based on a guideline developed on the level of ICH and published as ICH Q7A on “active pharmaceutical ingredients”.

It has an extended application both for the human and the veterinary sector.

Part III is intended to host a 10 GMP related documents, which are different to the generic guidelines on the principles of GMP laid down in Directives 2003/94/EC and 91/412/EC.

Part IIII

  • Compliance with good manufacturing practice (“GMP”) is mandatory for all medicinal products that have been granted a marketing authorization.
  • Advanced therapy medicinal products (“ATMPs”) must be manufactured under equivalent quality standards.

Part IIIII

  • Part IIII includes a series of annexes (19) providing details about specific areas of activity.
  • For some manufacturing processes, different annexes will apply simultaneously

 

DID YOU KNOW? 19th April 2022

Did you know? prime4services informs about EudraLex Volume 4!- Chapter 5

EudraLex – Annexes

In addition to the general matters of Good Manufacturing Practice outlined in Part I and II, a series of annexes providing detail about specific areas of activity is included.

For some manufacturing processes, different annexes will apply simultaneously (e.g. annex on sterile preparations and on radiopharmaceuticals and/or on biological medicinal products).

  • Annex 1 Manufacture of Sterile Medicinal Products
  • Annex 2 Manufacture of Biological active substances and Medicinal Products for Human Use
  • Annex 3 Manufacture of Radiopharmaceuticals
  • Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
  • Annex 5 Manufacture of Immunological Veterinary Medicinal Products
  • Annex 6 Manufacture of Medicinal Gases
  • Annex 7 Manufacture of Herbal Medicinal Products
  • Annex 8 Sampling of Starting and Packaging Materials
  • Annex 9 Manufacture of Liquids, Creams and Ointments
  • Annex 10 Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
  • Annex 11 Computerised Systems
  • Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products
  • Annex 13 Manufacture of Investigational Medicinal Products
  • Annex 14 Manufacture of Products derived from Human Blood or Human Plasma
  • Annex 15 Qualification and validation
  • Annex 16 Certification by a Qualified Person and Batch Release
  • Annex 17 Parametric release
  • Annex 19 Reference and Retention Samples
  • Annex 21 Importation of medicinal products

DID YOU KNOW? 12th April 2022

Did you know? prime4services informs about EudraLex Volume 4!- Chapter 4

EudraLex – GMP requirements for Advanced Therapy

  • Compliance with good manufacturing practice (“GMP”) is mandatory for all medicinal products that have been granted a marketing authorization.
  • Likewise, the manufacture of investigational medicinal products (IMPs) must be in accordance with GMP. Advanced therapy medicinal products (“ATMPs”) that are administered to patients under Article 3(7) of Directive 2001/83/EC1 (so called “hospital exemption”) must be manufactured under equivalent quality standards.

 

DID YOU KNOW? 5th April 2022

Did you know? prime4services informs about EudraLex Volume 4!- Chapter 3

EudraLex – GMP related documents

  • Part III is intended to host a collection of GMP related documents, which are different to the generic guidelines on the principles of GMP laid down in Directives 2003/94/EC and 91/412/EC.
  • The aim of Part III is to clarify regulatory expectations
  • Includes information on current best practices.
  • In addition to details on the applicability which are described separately in each document

Documents included:

1.Site Master File

2.Q9 Quality Risk Assessment

3.Q10 Note for Guidance on Pharmaceutical Quality System

4.MRA Batch Certificate

5.Template for the „written confirmation“ for active substances exported to the EC for medicinal products for human use

6.Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

7.Guidelines of 19 March 2015 on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use

8.Template for IMP batch release

9.Reflection paper on Good Manufacturing Practice and Marketing Authorization Holders

 

for more information visit the following link  https://ec.europa.eu/health/medicinal-products/eudralex/eudralex-volume-4_en

DID YOU KNOW? 29th March 2022

Did you know? prime4services informs about EudraLex Volume 4!- Chapter 2

EudraLex – Basic Requirements for Active Substances used as Starting Materials

  • Part II is established based on a guideline developed on the level of ICH and published as ICH Q7A on “active pharmaceutical ingredients”.
  • It has an extended application both for the human and the veterinary sector.

for more information visit the following link  https://ec.europa.eu/health/medicinal-products/eudralex/eudralex-volume-4_en

DID YOU KNOW? 22nd March 2022

Did you know? prime4services informs about EudraLex Volume 4!-Chapter 1

EudraLex – GMP requirements for Advanced Therapy Medicinal Products

  • The Chapters of Part I on “basic requirements” are headed by principles as defined in Directives 2003/94/EC and 91/412/EEC
  • Chapter 1 on Quality Management outlines the fundamental concept of quality management as applied to the manufacture of medicinal products
  • Each chapter includes:
    • Quality management objectives
    • Sufficient manufacturers information to be considered when implementing every principle

Chapter 1 Principles

  • Personnel
  • Premise and Equipment
  • Documentation
  • Production
  • Quality Control
  • Outsourced activities
  • Complaints and Product Recall
  • Self Inspection

for more information visit the following link  https://ec.europa.eu/health/medicinal-products/eudralex/eudralex-volume-4_en

DID YOU KNOW? 15th March 2022

Did you know? prime4services informs about EudraLex Volume 4!

Introduction EudraLex 

  • The European Commission (EC) has posted the current rules and guidelines about medicinal products on internet pages called ,EudraLex’
  • In this, two volumes about rules governing medicinal products for human (Vol 1) and veterinary use (Vol 5) show the EC legislation and actual status
  • The basic legislation is supported by a series of guidelines that are also published by 8 volumes of „The rules governing medicinal products in the European Union“
  • Within the next weeks, we will dive deeper into Vol 4 – Good Manufacturing Practice (GMP) guidelines

for more information visit the following link  https://ec.europa.eu/health/medicinal-products/eudralex/eudralex-volume-4_en

DID YOU KNOW? 08th March 2022

Did you know? ISPE APQ Guide: Change Management (CM) System has been released

  • APQ = Advancing Pharmaceutical Quality
  • What is the current state of your organization’s Change Management (CM) System?
    • Effective management of change throughout the product lifecycle enables quality improvement and is critical to patient safety, supply reliability, as well as operational effectiveness and efficiency
  • The Guide has been revised to align with current industry practice
  • This Guide focuses on
    • how to evaluate and optimize the system a company has
    • provides tools that can be used to improve the system
    • offers guidance on how to improve and develop a Change Management System that fits to a company’s maturity level

For more information, please check https://ispe.org/publications/guidance-documents/apq-guide-change-management-cm-system?utm_source=smartbrief&utm_medium=newsletter3/1/2022&utm_campaign=2022gdocs

DID YOU KNOW? 01st March 2022

Did you know? ISPE GPG Controlled Temperature Chambers 2nd Edition has been released

  • With the increasing complexity of global distribution for medicines requiring controlled temperatures, the new guideline provides guidance on the lifecycle management of GMP controlled temperature chambers
  • The guide has been revised to align with current industry practice, presenting a cost-effective way of demonstrating and maintaining compliance
  • The most significant changes are:
    • Improvements to the commissioning and qualification activities resulting in more efficient processes
    • Determining the periodic review frequency based on risk of failure
  • Additional revisions include:
    • Expansion of freezer types
    • Discussion about impact of construction materials
    • GxP storage facilities and warehouses descriptions
    • Enhanced descriptions of monitoring systems
    • High-level overview of decommissioning a unit
    • Considerations for using air-conditioned containers

For more information, please check Good Practice Guide: Controlled Temperature Chambers 2nd Edition | ISPE | International Society for Pharmaceutical Engineering

The NNIT Group acquires prime4services and further boosts its Production IT offering 25th February 2022

The NNIT Group acquires prime4services and further boosts its Production IT offering to the life sciences industry

With the acquisition of prime4services, Europe’s leading provider of Manufacturing Execution System services, the NNIT Group further solidifies its position within the international life sciences industry.

prime4services operates solely within the life sciences industry providing supplier-independent consulting and engineering services for digitalization of manufacturing processes, primarily through conception, implementation and validation of Manufacturing Execution Systems (MES): Improving manufacturing excellence through the efficient integration of MES into the existing system landscape is a key focus.

The company employs approximately 60 experts and is headquartered in Karlsruhe, Germany, with subsidiaries in Italy, Spain and Switzerland. In time, prime4services will be fully integrated with NNIT to form a MES Powerhouse, combining the Production IT Excellence capabilities of both companies.

Becoming a global leader within Pharmaceutical Production IT
In acquiring prime4services, the NNIT Group will be adding significant expertise and resources to its collective Production IT offering, which has already been significantly strengthened by the additions of Excellis (2020) and SL Controls (2021).

prime4services is home to one of the largest teams for Pharma MES implementation services in Europe, including its founding management who in combination have more than 100 years of experience within this field.

The Pharmaceutical Production area is one of the fastest growing IT areas within the Life Sciences industry, and with the acquisition of prime4services, NNIT will be well positioned to become a leading global player.

With the acquisition, NNIT’s Production IT offering will cover all aspects of the production value chain and have +350 life sciences experts working in the area.

CEO Pär Fors, NNIT comments:
“We see a strong strategic and cultural fit with excellent potential for making the NNIT Group one of the largest MES implementation services partners within life sciences. In order to maintain our momentum and ensure we can scale with opportunity, we need to accelerate our capabilities within this area. We heartedly welcome prime4services to the NNIT Group and look very much forward to joining our forces in a combined effort to deliver the very best service to our customers.”

Managing Director & Partner Beate Krüger, prime4services comments:
„Jointly, my partners from the initial days Yasmine Peters, Marco Glauner and I identified the opportunity to lift our prime4services business model to a completely different, globally acting, level by merging our methodologies, talents, and capacities with the NNIT Group. Over the past weeks, the open and constructive discussions we have had with the NNIT Life Sciences leadership team has confirmed our common company philosophy and values. As a joint team, we will cater to the demand of the life sciences manufacturing market for top-class Production IT consulting, implementation and operations services at a global scale.”

About prime4services
prime4services is an international consulting and engineering services provider with offices across Europe. Since 2009, the company has successfully supported the life sciences industry on a worldwide basis. The customer list includes numerous Fortune Global 500 pharmaceutical companies. prime4services actively engages with life science customers on their journey towards Industry 4.0. The team consists of 60+ experts specializing primarily in MES, T&T, OEE, LIMS, Quality & e-Compliance areas. Read more at https://www.prime4services.com/

 

Read more about NNIT’s Production IT solutions: Pharmaceutical production of the future is digital – NNIT

Read more about the NNIT Group: Our Group (nnit.com)

DID YOU KNOW? 15th February 2022

Did you know? PIC/S revises GMP guide to reflect new EU clinical trials regulation.

  • The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has revised its good manufacturing practice (GMP) guide (PE 009-16) to reflect the new EU clinical trials regulation (CTR), which took effect after years of delays
  • Specifically, Annex 13 of the PIC/S GMP guide, which relates to the manufacture of investigational medical products, is being replaced by the new EU Annex 13
  • PIC/S also announced the introduction of a new Annex 16 on certification by authorized persons and batch release
  • Both Annexes were approved by the PIC/S Committee and entered into force on 1 February 2022. The group encourages non-European Economic Area authorities and PIC/S applicants to transpose the annexes into their own guidelines

LINK to all GMP guide appendices: https://picscheme.org/docview/4590

PIC/S GMP guide: https://picscheme.org/en/publications?tri=gmp#zone

WE ARE HIRING 09th February 2022

 

#wearehiring #newjob #prime4services #greatplacetowork #lifescienceindustry

We are hiring!

We’re looking for energetic & passionate #consultants #mbr/recipedesigners #projectengineers #projectmanagers #qualitymanagers #qualityengineers & #experts with different levels of experience who want to support our MES, T&T, OEE, LIMS, Quality & eCompliance as well as Industry 4.0/Digital Factory projects in the Life Science Industry.
Interested? Get in touch with us: Jobs@prime4services.com

WE ARE HIRING 31st January 2022

#wearehiring #newjob #prime4services #greatplacetowork #lifescienceindustry

We are hiring!

We’re looking for energetic & passionate #consultants #mbr/recipedesigners #projectengineers #projectmanagers #qualitymanagers #qualityengineers & #experts with different levels of experience who want to support our MES, T&T, OEE, LIMS, Quality & eCompliance as well as Industry 4.0/Digital Factory projects in the Life Science Industry.
Interested? Get in touch with us: Jobs@prime4services.com

DID YOU KNOW? 25th January 2022

Did you know? ICH releases revised Q9 guideline to improve risk assessments.

The International Council for Harmonization (ICH) issued a revision of the Q9 guideline that aims to address the shortcomings of the current guideline. The goal of the revision is to provide „more scientific and robust applications of quality risk management principles (QRM)“ leading to „fewer quality defects and recalls“ and reduced costs for the pharmaceutical industry, according to an ICH business plan.

  • The ICH Q9(R1) guideline was published on the European Medicines Agency (EMA) website on 16 December and updates the original ICH Q9 guideline, which is now 16 years old.
  • The revision is intended to address four shortcomings of the current document:
    • High levels of subjectivity in risk assessments and in QRM outputs
    • Failure to adequately manage supply chain and product availability risks
    • Lack of understanding as to what constitutes formality in QRM work
    • Lack of clarity on risk-based decision making

ICH_Q9-R1_Document_Step2_Guideline_2021_1118.pdf

DID YOU KNOW? 18th January 2022

Did you know? FDA released a new draft guideline “Inspection of Injectable Products for Visible Particulates”.

  • The US Food and Drug Administration (FDA) has issued a draft guidance to help manufacturers set up inspection testing programs to ensure that their injectable drugs are free of visible particles.
  • Numerous recalls have been announced stemming from particle contamination of injectable products.
  • Other enforcement actions, such as warning letters, have followed from inadequate investigation of particles in injectable drugs.

 

  • The draft guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates
    • Product development
    • Manufacturing controls
    • Visual inspection techniques
    • Particulate identification
    • Investigational and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination

 

The deadline for commenting is 14 February 2022.

https://www.fda.gov/media/154868/download

DID YOU KNOW? 04th January 2022

Did you know the Twelve Principles of Agility?

  1. Highest priority is to satisfy the customer through early and continuous delivery of valuable products.
  2. Welcome changing requirements, even late in development. Agile processes harness change for the customer’s competitive advantage.
  3. Deliver working products frequently, from a couple of weeks to a couple of months, with a preference to the shorter timescale.
  4. Business people and developers must work together daily throughout the project.
  5. Build projects around motivated individuals. Give them the environment and support their needs and trust them to get the job done.
  6. The most efficient and effective method of conveying information to and within a development team is face-to-face conversation.
  7. The working product is the primary measure of progress.
  8. Agile processes promote sustainable development. The sponsors, developers, and users should be able to maintain a constant pace indefinitely.
  9. Continuous attention to technical excellence and good design enhances agility.
  10. Simplicity – the art of maximizing the amount of work not done – is essential.
  11. The best architectures, requirements, and designs emerge from self-organizing teams.
  12. At regular intervals, the team reflects on how to become more effective, then tunes and adjusts its behavior accordingly.
DID YOU KNOW? 16th November 2021

Did you know? ISPE recently released the ISPE GAMP® Good Practice Guide Enabling Innovation.

The first such guidance to discuss critical thinking, agile and IT service management in relation to the life sciences industry, the Guide seeks to apply ISPE GAMP® 5 principles and current good practice to these areas to promote innovation and advancement.

  • IT Service Management
  • Critical Thinking
  • Agile Software Development

 

For more information, please check following link:

https://ispe.org/pharmaceutical-engineering/ispeak/new-ispe-gampr-gpg-supports-innovation-life-sciences-industry?utm_source=smartbrief&utm_medium=newsletter10/19/2021&utm_campaign=2021gdocs

Join prime4services at Pharma MES Asia 22nd November 2021

Don’t miss our Speech based on experience at the Pharma MES Asia digital event on 22nd November at 12:45 and find out more about “How can harmonization and streamlining of processes support MBR Design & MES implementation?”.

Vishal Shah will take you through the following topics during his half an hour session:

  • Bottom-Up approach
  • Understanding „As-Is“ to drive „To-Be“
  • Outcomes of Process Analysis
  • Risks of Overlooking
  • Tools & Templates
  • Summary: Reusability of Process Mapping

We are looking forward.

“prime4SkillSet” is LIVE now. 20th September 2021

is LIVE now!

Are you looking for experienced hands & minds to accelerate your project in MES, T&T, OEE, LIMS, Quality & eCompliance as well as Industry 4.0/Digital Factory for Life Science Manufacturing?

prime4SkillSet is your marketplace to find your experts to support your needs.

Visit prime4SkillSet through the following link: www.prime4skillset.com or via www.prime4services.com!

Join prime4services at Pharma MES event in Berlin 27th September 2021

Join us at Pharma MES event in Berlin on 27th September at 16:30 and challenge your peer Thomas Schumacher on the subject “MES Recipe verification – verify your MBR the right way”.

The following topics will be discussed during this one-hour session:

  • When is the best time to start designing the verification approach?
  • What are the operational challenges of the different verification approaches?
  • How to turn the formal verification requirement into a beneficial deliverable for the project/operations?
  • What are the formal GMP requirements for the recipe verification?

 

Don’t miss our Client Study at the Pharma MES event in Berlin on 27th September at 17:30 and find out more about “The human factor behind the digitalization”.

Yvonne Mullins (prime4services) and Alan Kelly (Takeda) will take you through the following topics during their half an hour session:

  • The main pillars & most common pitfalls related to the people behind Digital Transformation projects
  • How one bad apple (`resister to change`) can have a profound negative impact on the overall project
  • Local to Global Transformation – ways of working and how to merge these
  • Lessons Learnt & Best Practices related to the Human factor during Takeda Singen Digitialization Transformation

 

prime4services clients are invited to join the event for free on a virtual basis:

Please register yourself under the following link: https://www.pharma-manufacturing-execution-system.com/join-pharma-mes-process-minds-digital

 

We are looking forward to your visit.

Announcement: Launch of “prime4SkillSet” on 20th September 2021. 20th September 2021

prime4services launches on 20th of September. Stay tuned!

 

Are you looking for experienced hands & minds to accelerate your project in MES, T&T, OEE, LIMS, Quality & eCompliance as well as Industry 4.0/Digital Factory for Life Science Manufacturing?

prime4SkillSet is your marketplace to find your experts to support your needs.

prime4services España 01st February 2021

prime4services officially disembarks in Spain after its success in Germany, Switzerland and Italy and announces the launch of the new subsidiary in Madrid, which went operational in February 2021.

prime4services España is committed to locally support their life sciences industry customers by providing consulting, engineering, and digitalization services around pharmaceutical manufacturing.

For more information, please contact prime4services España S.L.:
Javier Goitia
Managing director
Email: Javier.Goitia@prime4services.com
Mobile: +34 656 853 288

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prime4services A decade of hard work! 10th October 2019

At prime4services GmbH we are celebrating a very big milestone this month! A decade of hard work, innovation, respect and continuous improvements. A very big thank you to the amount of people that have made it possible, and cheers to the next 10 years!

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prime4services und Werum IT Solutions schließen PAS-X MES Servicepartnerschaft 19th June 2019

prime4services und Werum IT Solutions schließen PAS-X MES Servicepartnerschaft

„PAS-X Endorsed Service Partner“ für Europa / Skalierbare Services für die Implementierung von PAS-X MES / Kunden profitieren von Beratungsleistungen und weitreichender Erfahrung bei der Implementierung von MES, Track & Trace und OEE

Lüneburg, 3. Juni 2019 – Werum IT Solutions erweitert sein Dienstleistungsangebot und zertifiziert prime4services als „PAS-X Endorsed Service Partner“ für Europa. Damit ist prime4services qualifiziert, Pharma- und Biotechhersteller bei der Einführung von Werum‘s PAS-X Manufacturing Execution System (MES) an Standorten in der DACH-Region und in Italien zu unterstützen. Als Anbieter von unabhängigen Consulting-, Engineering- und IT-Dienstleistungen legt prime4services seinen Fokus auf die Steigerung von Qualität und Effizienz in der Produktion.

„Mit prime4services können wir den Support für unsere europäischen Kunden weiter verbessern und ausbauen, insbesondere in Italien“, so Torsten Isenberg, Senior Director Services bei Werum IT Solutions GmbH. „Als PAS-X Endorsed Service Partner bietet prime4services unabhängige Beratungsleistungen – in der Regel vor Ort beim Kunden – und erweitert damit nahtlos Werum’s Serviceportfolio für unseren gemeinsamen Kundenstamm.“

„Durch die Bündelung der Expertise von Werum und prime4services profitieren unsere Kunden von der langjährigen, umfassenden Erfahrung beider Unternehmen. Diese Partnerschaft ist ein Meilenstein und eine zukunftsweisende Entscheidung sowohl für prime4services als auch für Werum. Wir freuen uns auf eine spannende Zusammenarbeit“, so Yasmine Peters, Geschäftsführerin von prime4services.

Die PAS-X Endorsed Service Partner erfüllen alle Anforderungen des „PAS-X Service Partner“-Programms von Werum. Ziel ist es, Werum-Kunden überall auf der Welt den gleichen Qualitäts- und Servicestandard von Werum anzubieten – durch verlässliche, erfahrene und zertifizierte Partner und deren Mitarbeiter. PAS-X Service Partner verfügen über umfangreiches PAS-X-Produktwissen, nehmen regelmäßig an PAS-X-Schulungen teil, besitzen Erfahrungen in der regulierten Industrie und setzen ein Qualitätsmanagementsystem ein. Die Zertifizierung muss regelmäßig erneuert werden.

Von links: Torsten Isenberg (Werum IT Solutions), Nicola Catania & Yasmine Peters (prime4services), Reiner Kühl (Werum IT Solutions)

Über Werum IT Solutions

Werum IT Solutions ist der international führende Anbieter von Manufacturing Execution Systems (MES) und Manufacturing-IT-Lösungen für die Pharma- und Biotechindustrie. Sein Softwareprodukt PAS-X ist weltweit bei den meisten der Top 30-Pharma- und Biotechunternehmen sowie auch bei vielen mittelständischen Herstellern im Einsatz. Werums Manufacturing-IT-Lösungen helfen Pharmaherstellern, die Effizienz ihrer Fertigung zu erhöhen, die Produktivität zu steigern und die regulatorischen Anforderungen zu erfüllen. Werum mit Hauptsitz in Lüneburg wurde 1969 gegründet und verfügt über zahlreiche Niederlassungen in Europa, Amerika und Asien.

www.werum.com

Werum ist Teil von Medipak Systems, dem Geschäftsfeld Pharma Systems des internationalen Technologiekonzerns Körber. Das Geschäftsfeld umfasst die Unternehmen Dividella, Fargo Automation, Mediseal, Rondo, Seidenader Maschinenbau, Systec & Services, Traxeed und Werum IT Solutions, die weltweit führende Anbieter für qualitativ hochwertige Lösungen für den Herstellungs- und Verpackungsprozess pharmazeutischer Produkte sind. Unter dem Dach von Medipak Systems bietet Werum integrierte IT-Lösungen für sämtliche Phasen im Bereich der pharmazeutischen und biotechnologischen Produktion – von der Prozessentwicklung über die kommerzielle Produktion bis zur Verpackung einschließlich Serialisierung mit Track & Trace. Körber vereint weltweit international führende Unternehmen und erzielt mit fast 10.000 Mitarbeitern einen Umsatz von 2,6 Milliarden Euro.

www.medipak-systems.com, www.koerber.de/en

Kontakt:

Dirk Ebbecke

Director Corporate Communications

Werum IT Solutions GmbH

Wulf-Werum-Str. 3

21337 Lüneburg, Germany

Tel. +49 4131 8900-689

Fax +49 4131 8900-20

dirk.ebbecke@werum.com

Über prime4services

prime4services ist ein globaler Beratungs- und Engineering-Dienstleister mit Niederlassungen in Europa und Asien. Seit 2009 unterstützen wir erfolgreich die Life-Science-Industrie. Zu unseren Kunden zählen zahlreiche „Fortune Global 500“-Unternehmen. Wir arbeiten aktiv mit diesen Unternehmen zusammen und begleiten sie auf ihrem Weg zu Industrie 4.0. Unser Team besteht aus mehr als 40 Experten, die auf die Bereiche MES, T&T, OEE, LIMS, Quality & e-Compliance spezialisiert sind. Mit viel Engagement setzen wir uns gemeinsam für Kundenzufriedenheit, Innovation und die erfolgreiche Umsetzung unserer Projekte ein.

www.prime4services.de

 

Kontakt:

Yasmine Peters

prime4services GmbH

Rüppurrer Str. 1

76137 Karlsruhe

Tel. +49 721 60 957 888

Fax +49 721 60 957 980

yasmine.peters@prime4services.com

 

 

prime4services and Werum IT Solutions enter service partnership 19 June 2019

MES project excellence & implementation support:
prime4services and Werum IT Solutions enter service partnership

Customers benefit from independent consulting and experience in the field of MES, Track & Trace and OEE implementation / Scalable and supplementary services to support PAS-X MES implementation / „PAS-X Endorsed Service Partner“ for Europe

Lüneburg, Germany, 3 June 2019 – Werum IT Solutions further extends its range of services: prime4services has been successfully certified as „PAS-X Endorsed Service Partner“ for Europe. This qualifies prime4services to support pharma and biotech manufacturers during the implementation phase of Werum’s PAS-X Manufacturing Execution System (MES) at production sites in the DACH region and Italy. prime4services is a service provider for independent consulting, engineering & IT services to optimize both quality and efficiency and to drive manufacturing excellence at the customer’s site.

„prime4services helps us further improve and expand support services for our European customers, in particular in Italy,“ Torsten Isenberg, Senior Director Services at Werum IT Solutions GmbH, is pleased to announce. „As PAS-X Endorsed Service Partner, prime4services provides independent consultancy services – typically at the customer’s – and thus enhances Werum’s service portfolio for our common customer base in a seamless way.“

„By combining Werum’s and prime4services’s expertise, our customers will benefit from the long-term, complementary experience of our two companies. This partnership is a landmark and future-oriented decision for prime4services and Werum. We look forward to an exciting cooperation,“ says Yasmine Peters, Managing Director at prime4services.

PAS-X Endorsed Service Partners meet all requirements of Werum IT Solutions‘ PAS-X service partner program. The main objective of our program is to offer the same quality and competence of services to Werum customers all over the world – through reliable, experienced and certified partners. Our service partners need to have comprehensive PAS-X knowledge, participate at PAS-X trainings on a regular basis, possess experience in the regulated industries and use a quality management system. The certification has to be renewed on a regular basis.

From left: Torsten Isenberg (Werum IT Solutions), Nicola Catania & Yasmine Peters (prime4services), Reiner Kühl (Werum IT Solutions)

About Werum IT Solutions

Werum IT Solutions is the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Its PAS-X software product is run by the majority of the world’s top 30 pharmaceutical and biotech companies but also by many mid-sized manufacturers. Werum’s manufacturing IT solutions help pharma manufacturers to increase efficiency, improve productivity, and meet regulatory requirements. Founded in 1969, Werum is headquartered in Lüneburg, Germany, and has many locations in Europe, America, and Asia.

www.werum.com

Werum is part of Medipak Systems, the Pharma Systems business area of the international technology group Körber. The Business Area’s companies, Dividella, Fargo Automation, Mediseal, Rondo, Seidenader Maschinenbau, Systec & Services, Traxeed and Werum IT Solutions, are global leading providers of high-quality solutions for the manufacturing and packaging process of pharmaceutical products. As a Medipak Systems company, Werum provides integrated IT solutions for all phases of pharmaceutical and biopharmaceutical production – including process development, commercial production, and packaging as well as track & trace serialization. Körber unites around 10,000 professionals in industry-leading companies worldwide, achieving annual earnings of 2.6 billion Euros.

www.medipak-systems.com, www.koerber.de/en

Contact:

Dirk Ebbecke

Director Corporate Communications

Werum IT Solutions GmbH

Wulf-Werum-Str. 3

21337 Lüneburg, Germany

Tel. +49 4131 8900-689

Fax +49 4131 8900-20

dirk.ebbecke@werum.com

About prime4services group

prime4services is a global consulting and engineering services provider with offices across Europe and Asia. Since 2009, we have been successfully supporting the life science industry and have worked with many of the Fortune Global 500 companies. We are actively engaging with our life science industry clients on the journey to their next milestone towards Industry 4.0. Our team consists of 40+ experts specializing in MES, T&T, OEE, LIMS, Quality & e-Compliance areas, and all are committed to ensuring customer satisfaction, innovation and successful delivery on all projects.

www.prime4services.com

Contact:

Yasmine Peters

prime4services GmbH

Rüppurrer Str. 1

76137 Karlsruhe, Germany

Tel. +49 721 60 957 888

Fax +49 721 60 957 980

yasmine.peters@prime4services.com

 

 

The way you do your process makes difference Do Them SMARTT 27th March 2019

Our ad on the Manufacturing Technology Insights Magazine / March 2019.

https://www.manufacturingtechnologyinsights.com/magazines/March2019/3D_Printing/#page=3

 

 

 

Heralding The New Age Of Digital Pharma 08th January 2019

Read our article „Heralding The New Age Of Digital Pharma“  in the Manufacturing Technology Insight Special Edition on MES :

https://manufacturing-execution-system.manufacturingtechnologyinsights.com/vendor/prime4services-heralding-the-new-age-of-digital-pharma-cid-342-mid-47.html

 

 

 

Marco Glauner will be presenting at the Annual Supply Chain Innovation Leaders Summit 15th November 2018

SPEAKER ANNOUNCEMENT Marco Glauner prime4services Managing Partner will be presenting at the Annual Supply Chain Innovation Leaders Summit on the 4th -5th of December 2018 Barcelona, Spain. find more about the event on the following link: https://lnkd.in/ddWtN2x

Christmas Donation Concept 1st November 2018

Christmas is all about giving!

We at p4s believe that every human being has the right to be educated and employed with this concept we have started our yearly Christmas donation concept. With our professional strong partner NETZ Bangladesh we have been able to support 16 children in Charitabari, a village in the North of Bangladesh, to attend primary school, In addition to supporting other project as poverty reduction, environmental protection and human rights.

You can join us and donate directly to NETZ Bangladesh through the following link:

https://bangladesch.org/en/donation/online-donation.html

Pharma MES 2018 CHALLENGE YOUR PEERS: prime4services’ Beate Krüger will be at Pharma MES event in Berlin. 24th September 2018

Join us at Pharma MES event in Berlin on 24th September at 15:45 and challenge your peer Beate Krüger on the subject “How to master challenges of driving digitalization into process management from early development to commercial transfer?”

The following topics will be discussed during this one hour session:

  • Laboratory, pilot plant, commercial scale-up → identifying the drivers and scoping the target
  • From product data to product intelligence: Requirements, experiences, challenges
  • Overcoming hurdles on positioning, justifying and implementing digitalization projects in R&D

We are looking forward to your visit.

Pharma MES 2108 SOLUTION STUDY: prime4services’ Beate Krüger will be at Pharma MES event in Berlin. 24th September 2018

Join us at Pharma MES event in Berlin on 24th September at 12:00 and find out more about “Advanced Data Management and Paperless Documentation in the R&D arena.”.

Beate Krüger will take you through the following topics during her half an hour session:

  • The importance of data in the pharmaceutical product life cycle
  • From early development to commercial transfer: data from, information on and documentation of new products
  • Where non-GMP meets GMP – Paperless from technical to clinical process management
  • Endorsing Digitalization for R&D – a practical approach
  • Benefit and ROI considerations.

We are looking forward to your visit.

Pharma TRACKTS! 2018 SOLUTION STUDY: prime4services’ Marco Glauner will be at TRACKTS! event in Berlin. 24th September 2018

Join us at TRACKTS! event in Berlin on 24th September at 14:30 and find out more about “Beyond the rush of implementation – prepare for Serialization Operations”.

Marco Glauner (prime4services), Antoine Tracq (Galderma) and Johanna Roosen (Galderma) will take you through the following topics during their half an hour session:

  • Tasks for Serialization Operations Management
  • Challenges in Operations
  • Setup the required organisation
  • Get the right tools and guidelines in place.

We are looking forward to your visit.

Pharma TRACKTS! 2018 CHALLENGE YOUR PEERS: prime4services’ Marco Glauner will be at TRACKTS! event in Berlin. 24th September 2018

Join us at TRACKTS! event in Berlin on 24th September at 15:55 and challenge your peer Marco Glauner on the subject “Role of T&T in a Digital Factory …!?”

The following topics will be discussed during this one hour session:

  • Data shared with other manufacturing applications
  • System integration
  • Isolated T&T application vs. embedded feature
  • Extended use cases for T&T.

We are looking forward to your visit.

Announcement: Launch of “prime4SkillSet” on 24th September 2018. 24th September 2018

Are you looking for an experienced individual to accelerate your projects within the areas such as MES, T&T, OEE, LIMS, Quality / e-Compliance and Industry 4.0/Digital Factory for Life Science industry?

Visit our website and you can be just a few clicks away from finding the right skills and expertise that you need: www.prime4skillset.com.

prime4SkillSet functions as a Marketplace where all the prime4services team members CV’s are included in anonymous way enabling you to select your best match.

In addition to the CVs, you can search for SMARTTTM packages (https://www.prime4services.com/smartt/) as well.

We are looking forward to your visit.

Switzerland new office opening 1st January 2018

Based on our Goal to have a better global reach and to be closer to our Clients, today we are pleased to announce the opening of our new subsidiary in Switzerland which went operational in January 2018.
prime4services Switzerland GmbH will be operating in the fields of Manufacturing Execution Systems (MES), Serialization (Track & Trace), Systems and Overall equipment effectiveness (OEE), Laboratory Information Management (LIMS) as well as in the raising arena of Pharma 4.0.
For more information please contact p4s Switzerland office:
Yvonne Mullins
Managing director
Email: Yvonne.mullins@prime4services.com
Mobile: +41 79 857 91 53

India & UK Sales Offices opening 1st January 2018

Based on the strategic direction of Prime4Services (P4S) to expand its global footprint and be closer to understanding customer’s needs better in different geographic locations, we are pleased to announce the opening of our new sales offices in both India and the UK. These offices were established in January 2018, and will act as p4s Sales & Services offices under the P4S head office (Karlsruhe, Germany). Contact details for our new offices is as follows:

India: Vishal.Shah@prime4services.com
Contact No: +49 176 40778453 / +91 996 0694596

UK: Geoff.Gillies@prime4services.com
Contact No: +44 (0) 7879 694164
Address: p4s, 2 Umberstones, Virginia Water, Surrey GU25 4JL, United Kingdom

OEE announcement 1st January 2018

There’s no Time like Present for Continuous Improvement….

Because we are always keen to satisfy customers’ needs and develop our knowledge. We proudly announce the expansion of our services into the new expertise area of “Overall Equipment Effectiveness” (OEE).
OEE is a way to measure and improve the effectiveness of manufacturing processes of any scale and focus area. With its main characteristics being simple and practical, detecting the most common and important sources of productivity loss, revealing the “Hidden Factories” and turning it into metrics, makes it an excellent basis for improvement in manufacturing. Being known in the industry since multiple years, the latest approaches follow methodology more than technology – resulting in actual benefits and avoiding dead data pools – and make use of modern technologies on system integration as well as big data analysis … forming an important part in today’s Pharma 4.0 concepts.