This week a Medium sized San Francisco Bay area biotech company acquired DeltaPoint. The aim is to use DeltaPoint as an important tool in the ongoing validation process.

Most mature Life Science companies is now acknowledging that staying in a validated state depends on a well-defined and performed validation plan. DeltaPoint has the capability of doing most of the activities automatically, saving Life Science companies loads of resources.

Now more than 25 Pharmaceutical and biotech companies has bought the DeltaPoint software or licensed it during implementation and validation projects.

Epista IT CEO Klavs Esbjerg; We are of course very happy to recognize the fact that DeltaPoint is one of few tools which actually reduce the Compliance burden of Life Science companies while meeting legislation.

Read more about DeltaPoint and view short demos…

Contact: If you wish direct contact to epista IT or a open dialogue of how DeltaPoint might help your business please contact:

Bobby William Gray
Marketing and Sales Manager
M: +45 23 60 26 62
E:  bwg@epistait.com

The South Korean multinational company Samsung made a joint bio-similar venture with US Biogen Idec, named Samsung Bioepis.

epista IT is engaged by Samsung Bioepis to perform the SharePoint Qualification of their Compliance SP installation. Furthermore epista IT is responsible for the implementation of Compliance SP, configuration and tests in two environments.

epista IT will perform a Qualification plan to fit Samsung Bioepis. As part of the Qualification epista IT will deliver a full set of documentation including Qualification plan, Configuration Specification and perform all scripts for IQ, OQ and PQ. Furthermore epista IT is responsible for executing and assisting in the test activities.

epista IT is now present in most of Europe, North America and Asia, assisting more than 50 customers in the Life Science industry.

Would you like to get more information about how your business could gain from the knowledge and assistance of epista IT?  Then write an e-mail to info@epistait.com and we will get back to you soon.

Read more about epista IT Compliance services

Read more about epista IT 

Read more about QUMAS Compliance SP 

Karin Grostøl Nielsen brings more than 11 years of experience within the Life Science industry to epista IT. Karin holds a degree in Biology from the University of Copenhagen. Her industry expertise is grown through 9 years as Life Science consultant in NNIT, including roles as validation and technical responsible for IT systems as eCTD, document and quality management systems. Furthermore Karin has 2 years of experience working with regulatory IT systems and as product responsible at Statens Serum Institut.

Mike Redmond has 21 years of experience in the Pharmaceutical industry. He is a graduate Chemical Engineer experienced in Manufacturing Supervision, Process and Safety Engineering, Process Automation Systems, Engineering Project Management and Validation. Most of his industrial experience is earned at Pfizer.

At epista IT we are very satisfied about the accession of these two highly qualified consultants.

epista IT is still looking for highly experienced consultants to meet our growing activities in the Life Science industry. Read our job posting here…

- epista IT is now recruiting compliance consultants to the highly skilled team.

Job Description

You will be part of a team of 12 highly dedicated and skilled employees responsible for the development of quality plans, systems specifications and test strategies.

The tasks include business development and improvement projects, quality management of IT systems, test & validation in connection with new implementations or upgrades against compliance with regulations from authorities & internal business procedures.

Your assignments will be both individual and collaborative, depending on the customer and project need.

Desired Skills & Experience

The job function requests analytical skills and a professional, proactive and structured mindset.

You like to be in dialogue with people and feel comfortable in the role as advisor.

The ideal candidate will have a track record within the Life Science industry business processes,  especially in production, quality control and assurance or regulatory affairs.

Experianced in working with IT in the Life Science industry – long term projects in validation of IT systems or quality improvement of IT work processes is preferred. Furthermore experience in test management, test planning, test design and test execution are also valued.

You have at least a master degree and at minimum 4 years of experience working with IT-system development/operations, natural science or other business processes within the Life Science industry.

The ability to estimate validation activities is also preferred.

What you can expect

epista IT is a modern company, with a flat organizational structure. We believe that valuable knowledge is created in hybrid organizations with rapid flow of communication and knowledge sharing between heterogeneous individuals. Any employee are being challenged and advanced in their direction of interest.

Contact & Apply

For further information please contact Morten V. Larsen – ml@epistait.com

For applying send your Curriculum Vitae to Klavs Esbjerg – ke@epistait.com

The Norwegian pharmaceutical company Weifa has chosen to implement an Electronic Quality Management System (EQMS) to manage regulatory documents and quality processes across the organization.

The chosen solution is ComplianceSP provided by QUMAS, which are an innovative compliance management platform that combines the power of Microsoft SharePoint 2010 with the proven regulatory domain expertise of QUMAS. Combined with a best practice approach for managing documents, processes, people and tasks, ComplianceSP on SharePoint 2010 delivers a unique solution that can manage a wide range of compliance activities on the latest technologies.

During the project epista IT will assist in Project Support, Validation activities, User Training, System installation and configuration.

epista IT has additionally been assisting Weifa in the ‘Search & Selection’ process of finding the right solution.

Read more about:

epista IT Compliance Services

epista IT Validation Services

ProductLife, EXTEDO & epista IT would like to invite you to a joint webinar on 29 february covering the new challenges related to the EMA guidance on XEVMPD .

Missed this Webinar? Revisit the ‘Challenges and Solutions to Meet the EMA XEVMPD’

If you missed this Webinar you can watch the video here.

02 July 2012 is a major deadline to complete your product information e-submission to the EMA. A new format has been defined: the Extended Eudravigilance Product Report Message (XEVPRM), and the information that needs to be submitted to the EMA is extensively described in the detailed guidance.

• But how will marketing authorization holders address this major step?
• Do we have a clear understanding of the information required on our products and how to collect this information?
• How are we going to meet the deadlines in 2012 – internally, outsourced, a mix?
• Are our IT systems ready?

During this webinar, we will address these questions and provide attendees with practical solutions to meet this crucial deadline.

Read more about the MPDmanager.

Speakers at the Webinar:

• Klavs Esbjerg (CEO, epista IT)
• Katrin Spaepen (Managing Director Benelux/Scandinavia, ProductLife)
• Christian Kravogel (Product Manager, EXTEDO)

epista IT will shortly describe the experiences implementing IT systems like MPDmanager. Furthermore the future strategy of IT compliance services in a regulated and uncertain industry will be presented.

ProductLife will discuss the challenges from a regulatory service point of view including consultancy and staff augmentation through an outsourced service platform.

EXTEDO will present its new software solution MPDmanager, a Regulatory Master Data platform for XEVMPD and IDMP compliance. It supports applicants with an XEVMPD author system including wizard based data entry, it provides Excel & XML based interfaces for data import and export from various sources and it integrates with the EXTEDOsuite, product databases and other RIMS.

Starting Time & Duration

• 14:00 European Time (Copenhagen, GMT+01:00)
• 01:00 p.m., UK Time (London, GMT)

Duration will be about 70 minutes.

Registration:

The registration for this webinar is free of charge. Please register online at: https://www3.gotomeeting.com/register/715095326

New implementations of FirstPoint in Scandinavia

26 November 2011 – epista IT just engaged in two new contracts for the implementation of the document management system FirstPoint at two Scandinavian clients: Leo Pharma, a Danish pharmaceutical company specializing in dermatologic care and Algeta, a Norwegian oncology company.

Running on SharePoint environment, CSC’s FirstPoint has been successful in meeting the demand for compliant, secure and user-friendly document and collaboration management.

epista IT has long experience in implementing and validating SharePoint-based document management and quality management systems. The in-depth knowledge of worldwide top 5 SharePoint-based EDMS & QMS comes through our fruitful cooperation’s with partners, CSC among others.

Read also:

Document and Quality Management systems

SharePoint, the benefits of a common platform

Meet our partners

 
 
Two new clients choose SharePoint-based document management system

 
01 September, 2011 – Two new Life Science clients have chosen epista IT and CSC to help them streamline their Document Management processes: the Swedish pharmaceutical company KaroBio and a Denmark-based industrial biotechnology company.

Starting this autumn, epista IT will be assisting these customers with different assignments within implementation and validation of CSC’s FirstPoint, an electronic document management system running on SharePoint platform.

Find out more:
The benefits of Document and Quality Management systems
SharePoint for regulated systems
Why epista IT?

 
 
Two new clients choose SharePoint-based document management system

 
01 September, 2011 – Two new Life Science clients have chosen epista IT and CSC to help them streamline their Document Management processes: the Swedish pharmaceutical company KaroBio and a Denmark-based industrial biotechnology company.

Starting this autumn, epista IT will be assisting these customers with different assignments within implementation and validation of CSC’s FirstPoint, an electronic document management system running on SharePoint platform.

Find out more:
The benefits of Document and Quality Management systems
SharePoint for regulated systems
Why epista IT?

 
 
epista IT opens its Swiss affiliate

 
2 July, 2011 - With the establishment of its first affiliate, the Denmark-based consultancy epista IT aims to expand its services to European customers and strengthen its position as a leading provider of specialty IT compliance solutions for Life Science companies.

One of the world’s leading Life Science clusters, the BioValley gathers the regions of Northwest Switzerland, South Baden in Germany and Alsace in France. The cluster consists of approximately 600 companies, ranging from global large pharmaceutical companies to start-ups.

epista IT has assisted some customers in the BioValley region since 2009, when the spin-off consultancy firm started in North of Copenhagen, Denmark. Establishing an affiliate closer to the BioValley cluster was just a matter of time but, first, epista IT wanted to consolidate its activities in yet another important Life Science region, the Medicon Valley, which encompasses Northeastern Denmark and Southern Sweden.

After only two years of existence, epista IT is well-recognized as a reliable, highly specialized provider of IT compliance solutions in the Scandinavian market. Today, epista IT’s client base comprises more than 40 companies. It’s time to go further.

“A huge potential for optimization of business processes through IT lies within many organizations in the BioValley region, especially in the small and medium Life Science companies, and we have to be closer to them to be able to meet the demand,” says Klavs Esbjerg, managing director at epista IT.

The new office was officially inaugurated on 1 July 2011 and it is located in a pleasant area by Lake Zürich, about 25 km southeast of Zürich city and 90 km from Basel.