Electronic Document Management System (EDMS)

A well-functioning Electronic Document Management System (EDMS) is one of the cores of any Pharma Company. We have helped larger as well as smaller organizations with guidance and efficiency on already implemented solutions, but also strategies, request for proposals processes, implementation project and finally support and administration of EDMS solutions. In recent time we have been involved in quite a few Veeva Vault Projects, but we are technology agnostics and can do consultancy on a wide range of system vendors. Our services include:

Strategy

  • Scoping
  • Clarification of documents and processes to include in project and proposed phasing
  • Business case on implementation (optional)

RfP/Vendor Selection

  • Vendor Demos
  • Vendor Evaluation and Request for Proposal
  • Vendor selection
  • Negotiation
  • Contract management

Implementation

  • Project Management
  • Process and SME expertise
  • Quality Planning
  • Specification, Configuration and Construction with Vendor
  • Qualification/validation
  • Preparation for Go-Live

Maintenance

  • System maintenance and support
  • Training
  • Change Control
  • System Life Cycle Management

 

Meet the EDMS team:

Business Consultant
Peter Noes

Information technology professional with more than 13 years of experience from the pharmaceutical industry. Extensive business understanding and experience from IT projects mainly within the areas of Regulatory Operations – eSubmission (eCTD), Electronic Documents Management Systems (EDMS), Regulatory Information Management Systems (RIMS), XEVMPD and IDMP. Broad experience with project management, system administration and system implementation and with establishing and optimizing business processes within GxP areas.

Certified Veeva Vault Administrator, Computerized System Validation/GAMP5 and GDPR Foundation, Veeva
Business Consultant, Quality & Compliance Consultant
Lene Hyldgaard Jensen

Experienced Business Consultant with more than  10 years’ experience in the pharmaceutical industry working in various business partnering roles, preparing business analysis, facilitating workshops, transforming business requirements into IT development and implementation projects and delivering subject matter expert assignments, especially in the Regulatory area. Hands on Quality and Compliance experience with GxP IT systems and writing of Standard Operating Procedures.

ISPE GAMP 5, ITIL, Project Management, GLP, GCP, Veeva
JakobJuulRasmussen
Partner, Management Consultant
Jakob Juul Rasmussen
+ 45 24 34 26 55

IT Program/Project Manager with 16 years of experience within the pharmaceutical industry, finance and the public sector. Experience with infrastructure, service delivery management, application development, SOA and SAP projects

Project and Program Management certified in IPMA level A, PMP, MoP, PRINCE2, MSP and Professional SCRUM master
JRK 2017 BW
Business Consultant
Jannie Rosenkjær Melbye

Senior Pharma Consultant with 11 years’ experience within document/information and application management. 17 years’ of experience in the field between IT and business. Experience with GxP, application management – especially document management, functional and technical support, test and validation. Furthermore, experience within ITIL, vendor management, communication with end users, transition and application management.

Certified in ITIL, Computerized System Validation, SAFe Agilist