Milan Paperless validation event 20/09/2018

Qualitate showcases ViMS: cutting edge technology to accelerate Quality and Compliance.

On September 20th, Qualitate, in collaboration with Micro Focus and NL42 organized a breakfast and lunch session in Milan attended by representatives of important pharmaceutical companies from the region.

Micro Focus shared their vision on Application Delivery and how their wide range of tools enable customers to deliver applications at higher speed and confidence. Andrea Viola, responsible for the Southern Europe partner ecosystem, explained the Micro Focus partner strategy and the support to partners who develop custom solutions based on their toolset. Qualitate, a Micro Focus Silver Business Partner, has developed ViMS for ALM to enable regulated companies to accelerate quality and compliance by removing all paper from their validation processes.

NL42 co-founder Roberto Castelnovo set the stage for paperless laboratories highlighting how increasing requirements for Data Integrity make the use of computerized systems a necessity rather than a luxury. He explained some of the common pitfalls when acquiring a paperless management solution and shared insights to improve the efficiency and quality in the acquisition, implementation and management of paperless lab solutions.

Qualitate founder Ewout van Driel then performed a live demo of how ViMS enables us to manage the entire validation lifecycle in a paperless way. The session generated a lot of interaction of participants about validation practices and how these can be managed with ViMS. Some highlighted topics are:

  • The ever-increasing workload of QA and validation departments and how manual, paper based processes are simply not sustainable.
  • How the management of the entire validation process in ViMS optimizes the validation effort by eliminating duplicate activities, reduces review cycles by up to 90% and fosters cross-departmental collaboration.
  • The speed at which we can generate and obtain the required approvals for validation documentation using ViMS electronic signatures.
  • The ease of configuration of ViMS to be adapted to each customer´s requirement.

The main conclusion of the session is that cutting edge technology is now available to manage the compliance of computerized systems, and today’s professionals need to take the opportunity to use this and let it help them to work in a structured yet optimized way, eliminating waste such as paper and its filing from the validation process.

The average rating of the event – 4.4 out of 5 – reflected the interest and participation observed during the presentations and demo and the relevance of the presented topics in today’s challenging environment.

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Paperless Validation with ViMS – Milan event 20/09/2018

Accelerating the validation of computer systems in the pharmaceutical sector through the use of application life cycle management.

YOU’RE INVITED

Paperless Validation – Accelerating Quality and Compliance.

Qualitate invites you to a breakfast session where together with Micro Focus and the Paperless Lab Academy we will share the benefits of leveraging cutting edge technology to accelerate Quality and Compliance.

If you wish to attend this session, please register at the bottom of this page.

Paperless Lab Academy

The Paperless Lab Academy is an European annual congress and a learning platform for discussions on strategies and implementation of 21th century technologies in the laboratory. It is about discussing key milestones to generate solid business insights from the laboratory, connecting with colleagues who share similar operational issues as you have, learning about user’s case studies and how they are deployed into their processes, discovering the informatics trends from cutting-edge thought leaders, being in the know about the last informatics tools and methodologies in a creative and productive atmosphere. The 6th edition has ran in Baveno, Italy and so will the 7th edition on April 2019.

Validation information Management System

ViMS is a turnkey solution built on Micro Focus ALM, fully adapted to the regulatory environment. It provides integrated management of requirements, designs, risks, testing, validation protocols, deviations and reporting according to GAMP5.
ViMS incorporates electronic signatures and configurable routing for review and approval, decreasing the use of and need for hard-copy document based records, streamlining the validation and registration processes, and providing total traceability and control of changes.

AGENDA

09:30 – 10:00 Welcome
10:00 – 10:20 Introduction Micro Focus ADM, Andrea Viola, South Channel Manager Micro Focus
10:20 – 10:50 Setting the stage for a “Paperless” Lab – Roberto Castelnovo, owner NL42 Consulting
11:00 – 12:30 Introduction and hands on demo ViMS for ALM – Ewout van Driel, owner Qualitate
12:30 – 12:45 QA and wrap-up
12:45 Networking and lunch

DATE AND PLACE

Date: Thursday 20th September
Location: Starhotels ECHO
Address: Viale Andrea Doria 4 20124 Milano – Italia.

REGISTRATION

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    Use case presentation – ViMS at Kern Pharma

    Presentation of the use of ViMS – Validation information Management System at Kern Pharma.

    On May 22nd, Qualitate, in collaboration with Micro Focus and Kern Pharma, organized a breakfast session in Badalona attended by important pharmaceutical companies from the region.

    We were glad to welcome representatives of important pharmaceutical companies such as o Ferrer, Grifols, Hipra, Kern Pharma, Menarini and Reig Jofre.

    After introductions by Qualitate and Micro Focus, representatives of the Kern Pharma IT Validations department presented their experiences of using ViMS on a day-to-day basis, including a demonstration of how they manage the validation process with ViMS.

    The presentation generated a lot of participation and a good debate about validation practices and how these can be managed with ViMS. Among the many benefits, those that generated most interaction and interest were the following:

    • Ability to manage user requirements, design reviews, risks, tests protocols, executions and evidences, reports and defects registered in a single online system.
    • Reduction in time and effort required for reviews and apporvals and the overall validation process.
    • Fully paperless validation leveraging the electronic records and signatures in the system.
    • Easy generation of standard and custom reports.
    • Convenient online execution of protocols and capture of test evidence.
    • Complete traceability and visibility of the content registered in the system and its audit trail to guarantee the integrity of the validation data and records.

    The main conclusion of the session is that although organizational structures may vary, compliance and regulatory requirements are common to all, and for that reason ViMS is an excellent opportunity to work in a structured way, eliminating any paper and its filing for the validation of  computerized systems.

    The average rating of  the event – 4.7 out of 5 –  reflected the interest and participation observed during the presentations.

     

    We want to thank Kern Pharma for its magnificent presentation of ViMS, highly valued by the attendees, and all the attendees and speakers for their participation in a very interesting event.

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