Consulting Services

Business Consulting / Project Management

Supporting you on your digitalisation journey. From business analysis, business case development, supplier selection, implementation to business embedding. Done with all required documentation for a successful GxP validation.

Experience from

ERP system selection and implementation
Implementing Quality Management Systems and its supporting IT System
Regulatory system implementation for registrations, submissions and archiving
Implementing Patient Safety system for case processing and reporting
Human Resource HRM system implementation
Corporate communication system and Document Management Systems processes and its IT systems
Governance of IT systems including Application support set-up
IT QA and Data Integrity processess and operations

Applications such as IFS, Veeva Safety, Veeva RIM, Veeva QMS and Veeva QDocs has been used to successfully implement business processes.

Quality and IT Security Processes Support

By using structured problem solving and lean tools, the business processes will be designed for sucessful operation. With the experience from big pharma to small start-up, we know how to adjust the processes to your needs.

Experience in implementing and operation of key quality and security processes, such as

Complaint Management
Change Management
Deviation Management
Audit and Inspection Management
Document Management GxP, Medical Device and Cosmetics
Quality Management Review
Computer System Validation
Data Integrity
IT Service Management
IT Security Managment - ISO 27000, NIST

Training courses in

Computer System Validation and Data Integrity
Automation, ISA 88 Batch Management and ISA 95 MES
IT Security

Reporting and KPIs

By having regular reporting from your quality processes you can demonstrate that your are in control and focus your improvement projects in right area.

For clients we have built dash boards and reports that collect data from various systems and present these in one collective view out of Microsoft powerBI.

Azure Purview compliance management reporting - excellent tool to drive security and complince improvements in your organisation.