IT QMS & Computer System Validation

Pharma IT is experienced in all parts of computer System Validation. We have numerous consultants working with ensuring the compliance of GxP critical computer systems. We have experience in IQ/OQ/PQ, risk based validation and Agile methodology in the Pharmaceutical sector.

We can create and maintain the right levels of specifications and ensure your computer systems will pass through regulatory inspections.

Besides that, we can Audit you to ensure their compliance, and guide you in writing an IT QMS to assist your organization in meeting regulatory requirements.

Our services include:

  • Risk Assessments
  • Software Vendor Audits
  • User Requirement Specifications
  • Validation Plans and Reports
  • Installation, Operational and Performance Qualification plans and reports
  • Quality in Data Migration
  • System Management SOPs and processes
  • Commissioning and Decommissioning
  • Information Security Management System (ISMS)

We hold certifications within CISSP (IT security), ISO27001, CISA (Information System Audit), CISM (Security Manager), GxP, Computerized System Validation, Data Integrity, ALCOA principles, 21 CFR Part 11 / EU Annex 11

Meet the Computer System Validation team:

Senior Pharma Consultant
Maiken Forsberg

Pharmacist with 10 years of compliance and  IT System Management experience in line with GAMP 5, 21 CFR Part 11, ISO/IEC 27000 suite for IT security, ITIL and ICH guidelines (GMP, GLP, GCP, GVP). Maiken has helped several pharma companies establishing or improving IT documentation and SOPs prior audits or inspections with good results. She has implemented as well as retired a variety of complex pharmaceutical IT systems. 

ITIL 4 Foundation Certification, LEAN (cLEAN), eTIMS, GAMP 5 - 21 CFR Part 11 Data Integrity and IT Security, GAMP 5 ISPE, TIMS training
Senior Pharma Consultant
Pia Nøhr Ellegaard

Pia Nøhr Ellegaard holds more than 20 years of experience with Software-, Hardware and implementation projects of which 11 years have been in the pharmaceutical industry.
She is highly specialized in GxP. She has performed in roles such as Compliance Consultant , Test Manager, Trainer and QA. She has worked within most pharma domains.

ECA Certified Computer Validation Manager, ISEB Certified Tester
Quality & Compliance Consultant
Mike Astrup Nygaard

Experience from several pharmaceutical companies, working with various compliance and test assignments within GxP. Mike is experienced in taking lead and ownership of all types of compliance tasks from user requirement specifications, to validation plans, testing and reporting.

Mike has performed the role as Compliance Consultant, Validation Lead and Test Manager on IT projects and is specialized in GxP.

Mike has hands-on experience with preparing, reviewing and ensuring the right level of compliance in documentation for GxP systems – from Validation and Quality plans, URS, Risk Assessments, protocols and test cases to reports.

He has experience from international projects and teams with different nationalities. Mike is accustomed to working with several stakeholders and communicating at all levels of the organization.

ITIL, ISPE GAMP5
Quality & Compliance Consultant
Marianne Munck

More than 25 years’ experience in the Pharmaceutical Industry with a strong understanding of the pharma business by working in companies like Novo Nordisk, Bristol-Myers Squibb and NNIT in various areas: Quality Control, Quality Assurance, Organic Synthesis, Basic Research, Pharmacovigilance and life science IT Systems.

Computerized System Validation, Maintaining Control in Operation, Computer System Validation Master Class
Quality & Compliance Consultant
Tine Falk

More than 15 years of experience with implementation projects and system operation. She is highly specialized in GxP. She has performed in roles such as Compliance Consultant and Test Manager.

Tine also have 5 years of experience as SAP System Manager in a highly complex environment.

Computerized System Validation, ISEB Foundation and ITIL Foundation
Quality & Compliance Consultant
Pernille Juel Schjørring

Holds more than 16 years’ experience in the pharmaceutical and Medical device industry working with compliance documentation, validation, test best practices and testing of both GxP critical and no-critical IT-systems.

SAFe® Agilist Certification Exam, PRINCE2 ITIL®V3, ISTQB® Certified Tester, Advanced Level, Test Manager, GAMP, ISEB, 21 CFR Part 11.
Quality & Compliance Consultant
Nini Redøhl

More than 10 years of experience with IT compliance, Quality Management and System Administration within the Pharmaceutical industry. Working as Validation Track Lead in IT implementation and upgrade projects.

Experience primarily with Corporate GxP systems within the Regulatory, Quality and R&D area. Also experience with international projects, external vendors and offshore personnel.

Certification: ITIL Foundation, Computer Validation Manager, Lead Auditor and SAFe 4 Agilist
Quality & Compliance Consultant
Lea Elsborg Olsen

Holds experience working with data, modelling and statistical analyses within the cancer research industry. Assisting Compliance Manager experience.

Foundation ISTQB Certified Tester programme
Quality & Compliance Consultant
Jesper Damborg Bendtsen

Holds more than 17 years’ experience in the pharmaceutical industry working with validation and compliance. Jesper’s experience spans IT implementation projects, validation, compliance projects, and IT system administration.

Avoiding non-Compliance in Packaging Operations; Validation of Ventilation (HVAC); QA and System Manager for GxP critical IT systems; Qualification of cooling facilities
Quality & Compliance Consultant
Ilhem Sahnoun Østergaard

Senior Consultant with over eighteen years’ experience in the Pharmaceuticals Industry.
Active senior level professional with extensive experience in Computer System Validation (CSV) and in Test Management.
Background includes: Management of IT Compliance, IT Project Management in GXP area, Computer System Validation, IT Quality Assurance, Qualification of the GXP IT infrastructure, advising/consulting with IT associates on matters pertaining to compliance, conducting Training in GXP, Management and Administration of GXP applications.

Certified in Computerized System Validation/GAMP5
HeidiNoerTroelsenR
Quality & Compliance Consultant
Heidi Noer Troelsen

QA and Compliance Specialist with +20 years of experiences within the Pharmaceutical industry. Hands on experienced as a laboratory Technician, IT supporter, Project Manager, IT QA, Quality Specialist, QA, IT Compliance Consultant, Auditor, QA People Manager and Quality Director.

Certified in GxP, Computerized System Validation, 21 CFR Part 11 / EU Annex 11, Quality Risk Management, Audit Management and ITIL
FieKrossdal
Quality & Compliance Consultant
Fie Krossdal

Cand. Scient. in Health Informatics.

2 years of experience within IT compliance assisting Validation Track Lead in IT implementation projects.

Experience with RPA(programming and processes) projects as well.

Certified in Computerized System Validation/GAMP5
Business Consultant
Steen Lindebjerg

IT Program/Project Manager and Senior Pharma Consultant within Identity Management and GDPR with more than 20 years of experience from the IT industry within Pharmaceutical, Finance, Food and Public sectors. Experience with wide range of projects and operation in Infrastructure, IAM & Security, Application development, process optimization and IT service management.

SAFe 4 Agilist, PRINCE2, ITIL, GDPR Practitioner, CIPP/E and Certified Engineer in Microsoft Infrastructure MSCE and Nowell Network CNE
DorteJuulR
Quality & Compliance Consultant
Dorte Juul

More than 13 years of experience with IT compliance, Quality Management and System Administration within the Pharmaceutical industry. Working as Validation Track Lead in IT implementation- and upgrade projects.

Experience primarily with Corporate GxP systems within the Regulatory, Quality and R&D area. Also experience with international projects, external vendors and offshore personnel.

Certification: CISA, ITIL Foundation, Computer Validation Manager, Lead Auditor and SAFe Agilist
DanAndersenR
Quality & Compliance Consultant
Dan Andersen

30 years of pharma experience from multiple area of business and levels of responsibility with a constant focus of delivering compliant solutions. Hands on experienced as a Security Manager, QA, Compliance Specialist, Validation Specialist, Project Manager and Process Technician.

Certified in CISSP (IT security), CISA (IS Audit), CISM (Security Manager), GxP, Computerized System Validation, 21 CFR Part 11 / EU Annex 11, LEAN and ITIL, Veeva
BenedikteMarieDueBW
Quality & Compliance Consultant
Benedikte Marie Due

More than 10 years of experience with IT compliance. Working as Validation Track Lead in IT implementation projects and as Business Consultant in system operation and maintenance.

Experience primarily with corporate GxP systems within the Regulatory, Quality and R&D area. Also experience with international projects, external vendors and offshore personnel.

Certified in Computerized System Validation/GAMP5, Certified Veeva Vault Administrator, Veeva
Quality & Compliance Consultant
Arash Gohar

Senior Automation & IT Engineer with expertise in design, configuration, test and commissioning of fully integrated BMS/EMS platforms, energy metering and power management, central plant equipment in both GxP and non-GxP environments. Test and Qualification of MES system

eTIMS, GDP, HSE, Advances in Syncade and SIMATIC S7
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
Quality & Compliance Consultant
Anders Winkel

Anders Winkel has 9 years of work experience doing research at the University of Copenhagen. He has had experience in using a broad suite of analytical software such as Graph Pad Prism, SensorTrace Suite, PicoLog and GIS.

In Pharma IT he is acting as assisting compliance manager and he has also led several process analysis initiatives.

GAMP 5
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
Quality & Compliance Consultant
Anders Jakobsson

Anders Jakobsson holds in total 36 years of experience in Software quality and development. Anders holds more than 25 years of experience in the pharmaceutical industry working with QA, regulatory compliance, supplier audits and QMS development and roll-out.

Anders has experience in different areas of the pharmaceutical business such as GCP, GVP, GMP, GDP and medical device. Computer systems support in areas such as Production automation, Laboratory automation, ERP incl. serialization, Pharmacovigilance, Clinical Trials, Regulatory Affairs.

SAFe 4 Agilist, ISA S88 and S95, ISO 9000, 21 CFR Part 11, GMP Training Courses: manufacturing, distribution, auditing, batch release