Software Validation Risk Management Software Testing Business Analyses Compliance Management Auditing

High Quality Through Pragmatic Processes

By compliance we mean the adherence to regulative laws and directives and to external and internal standards and requirements. Companies are required to provide the respective evidence of compliance activities. 

Pragmatic validation
The balance between discipline and agility, between effort and value is considered in our approach which we call  pragmatic validation.

We align with industry standards, i.e., GAMP 5, IEEE and the respective ISO standards. For testing and requirements engineering we align with the certification schemes of ISTQB and IREB (International Requirements Engineering Board) considering Best-Practice. The minimization of risks and optimization of value flows are the focus of our work. 

    Your added value

    • You pragmatically implement regulative requirements (FDA, GxP, MPG usw.) and improve your process
    • You qualify and validate processes, equipment on computerized systems.
    • You implement the most appropriate methods and tools for risk analyis and management.
    • You have partners that certify you software, and your procedures.
    • The competency of your personnel is high and reduces costs of compliance sustainable.

    Case

    Your request: Our software development life-cycle should be changed from waterfall to agile.
    Discussion: The new  life-cylcle model should accommodate the current life-cycle model, but purge the known weaknesses. It should be audit compliant.
    Proposal: 20 person-days effort
    Mandate: Proposal accepted
    Achievement: Project and Quality Handbook adapted to iterative / incremental.
    Deliverables and roles newly defined.
    Software life-cycle and project lifecylce model and terminology according to GAMP5
    Several reviews performed.
    Approach chosen: Our common approach was incremental, time-boxed, and based on our "project" backlog. 
    Outcome: Project and Quality Handbook created and accepted. a Time-Boxed process implemented,  Business Driven Development process for early requirements validation and automated testing established, continuous testing and delivery procedures and tools defined. Configuration Management and IT Service Management were newly included in the software development model.
    Your value: Audited by a Pharma competitor with no findings / observations
    Our role: Methodologist, Analyst, Scrum Coach