IT Quality Management

Why the wizlynx QM Competence Center?

  • Do you have a plan to build your own Quality Management System or revamp your current one?
  • Do you have requirements to comprehensively assess your IT governance maturity level?
  • Do you have a need for FDA audit readiness?
  • Do you need to ensure your IT Governance and IT Operations organizations meet GxP requirements?
  • Do you have challenges acquiring resources with the right skill set and expertise level in computerized system validation?
  • Do you face unplanned budget reductions restricting internal hiring?

Consider the flexible and customizable wizlynx “QM as a Service” model to successfully meet your requirements more efficiently and effectively. We embrace end-to-end quality management as a core business process and competency to manage and execute strategic business investments; we give you all the “tools” you need to successfully achieve compliance in their environment on time, with quality and within budget.

What Our QM Competence Center Can Do For You

  • Ensure Compliance With Your Quality Management System (QMS)
  • Change the Quality Culture
  • Provide IT Governance Assessment
  • Implement New Methods and Processes
  • Support Project Base Quality and Compliance
Quality Management Competence Center

QM Catalog

Ensure Compliance With Your Quality Management System (QMS)

Corrective And Preventive Action (CAPA) Management
  • Periodic assessment
  • Archiving Strategy
  • Retention period and system retirement
Ensure Compliance With Your Management System (QMS)
  • Infrastructure Qualification
  • Monitor and enforce adherence to your internal QMS consistently across the organization
  • Improve (continuously) existing processes to raise compliance and efficiency
  • Simplify complicated practices to maximize resource availability
Establish Quality Management System
  • Definition of Back-up and Restore Strategy
  • Disaster Recovery and Business Continuity Plan establishment and periodic testing
  • Information Asset Management
  • Mock inspection and audit readiness
  • Change Control Strategy
  • Configuration Management
  • Support on service level agreement definition and review
Full Computer System Validation
  • Vendor audit
  • Requirements engineering
  • Gap analysis and risk assessment
  • Design qualification
  • Data migration analysis and support
  • Definition and preparation of qualification protocols
  • Evaluation of requirements for data integrity security and confidentiality
  • Operational handover management

Change the Quality Culture

Change the Quality Culture
  • Act as the agent for change
  • Embed quality as a natural feature in every activity
Tailor Resource Development Program
  • Training material preparation
  • Training roll-out program
  • Development of web-based training program
  • Coaching of internal resources to ensure sharing

IT Governance

Implement New Methods and Processes
  • Design and build processes that work for the IT organization
  • Use best practices and structures
  • Enable compliance through new process
IT Governance Assessment
  • Assess the design and effectiveness of IT Governance
  • Review the effectiveness, efficiency and appropriateness of information management processes and controls
  • Remediation Management
Support Project Base Quality and Compliance
  • Support Project Manager through the project delivery, especially in covering compliance
  • Establish the quality goals for the project
  • Review and approve project and system life cycle documentation items

Core Competencies

  • Standards & Frameworks
    Experienced in widely used standards and frameworks along with tools and processes (e.g. PMBOK, PRINCE2, COBIT, RUP, CMMI, Agile, Waterfall, GAMP, CSV, ISO)
  • Certifications & Education
    Competence Center members hold various certifications (e.g. CISA, CGEIT, CRISC, PMP, PRINCE2, ITIL) and have extensive education and experience in regulatory compliance (e.g. SOX, GxP, GMP, GLP, GCP, ePHI, PCI, 21 CFR Part II)
  • Enterprise Knowledge
    Strong experience in IT, telecom, banking, insurance, nutrition and pharmaceutical industries
  • KPI Management
    Customizable catalog of key performance indicators proven to provide critical management information
  • QM Assets
    Comprehensive framework of documents, processes and tools to support our QM services
  • QM Best Practices
    Repeatable best practices deployed as a baseline accompanied by a governed continuous improvement process
  • Training & Coaching
    Customizable training and coaching program focused on project performance improvement globally and cross-culturally