Pharma IT Services

Pharma IT focus on delivering services and consultancy related to business and IT within the Pharmaceutical Industry. We focus on quality and set high standards for ourselves.

Our identity is to be agile and competitive, we only engage with the best - our consultants are skilled and professional, having many years of experience within Pharma and IT.

Pharma IT offer services and consultancy within the following area's/domain's:

Pharma IT services

Project, Program and Service Delivery Management 

Regulatory Operations

Pharmacovigilance *NEW

Our Program and Project Management consultants have several years of experience in delivering successful program and projects within the pharmaceutical industry and business domains.

We hold certifications within:

  • IMPA level C-A
  • PMP
  • PRINCE2
  • MSP
  • ITIL
  • Agile methodologies

We have experience in delivering IT solutions to support the Regulatory Affairs business processes:

  • Document Management
  • Submission Management
  • Regulatory Information Management Systems
  • xEVMPD reporting
  • ISO IDMP reporting
  • Records Management

The Pharma Industry must comply with the requirements to report in ISO IDMP format. We are tracking the latest development in respect to the IDMP reporting requirements and have knowledge in the available options to become IDMP compliant pending on your size and needs.

 

Companies are experiencing an increase in number of ICSRs and with new requirements from authorities support in daily work and optimization of existing working processes are needed.

Our consultants are experienced within:

  • ICSR processing and reporting
  • Signal Detection
  • PSUR/PBRER and DSUR writing and submission
  • Risk Management Plans
  • Maintaining and building quality management systems
  • Pharmacovigilance training
  • Medical Information
  • Promotional Material

 

IT Quality, Compliance and Security Management 

Supply Chain / Serialization

Business Quality and Compliance Management

Our IT Quality and Compliance Consultants are specialists in implementing compliant and secure IT systems from any 3rd party vendor. We are experienced in delivering risk based GAMP compliant project implementations:

  • 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 Certified in 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

We have several Serialisation experts who have been part of implementing systems to handle serialisation in major Pharmaceutical companies.

We have implemented solutions for, China, South Korea, US and Saudi Arabia, and are familiar with the EU Delegated act.

We can cover the following areas within Serialisation:

  • Technology implementation of SAP ATTP
  • Analysis of CMO landscape
  • Technical evaluation of CMO maturity
  • Interface test
  • Documentation and training of end users who work with serialisation

Our Business Quality and Compliance Consultants can support and QA and QC activity being part of the daily business within a Pharmaceutical Department:

  • Change Management
  • CAPA Management
  • SOP Management
  • Training Management
  • Inspection Readiness
  • Audit Management
  • General Data Protection Regulation (GDPR)
    • Data Protection Impact Assessment (DIPA)
    • Data Protection Officer (DPO) services
    • GDPR implementation consulting services

We hold certifications within Quality Risk Management, Lead Auditor and Audit Management as well as GDPR

 

Should you be interested in getting more information please contact us here