Computer Validation

Computerized systems that are used in the production of finished pharmaceuticals and/or active pharmaceutical ingredients strongly contribute to product quality and consistent performance of production facility substantially eliminating manual labor and risks related to the “human factor”. At the same time the high level of complexity of such systems may by itself pose risks for product quality and safety, which is connected to possible faults in the design, installation/programming, operation, maintenance and retirement of computerized systems.

It is therefore required that a risk-based approach to computerized systems is applied and corresponding life-cycle activities are incorporated into the pharmaceutical manufacturers Quality Management System (QMS) inline with Good Automated Manufacturing Practice (GAMP 5) guidelines. The term Computer Validation is used both as a general concept to address the whole life-cycle of a computerized system in accordance to GAMP 5 / 21 CFR Part 11, as well as for the actual validation activities that are the part of the systems life cycle.

Pharma Group Baltic has IT and automation specialists experienced in GMP/GAMP and a number of successfully accomplished computer validation projects.

We can offer to our Clients a wide range of services/activities related to a computerized system life cycle / computer validation:

Planning and QMS documentation

    Development of policy and general procedures (in respect to computerized systems):

      Development of policy
      Distribution of roles and responsibilities (SOP)
      Training (SOP)
      Supplier management (SOP)
      Creating / maintaining registry of systems (SOP)
      General planning of validation (SOP)
      Planning of monitoring / improvement (SOP)

    Identification of compliance standards

    Identification of system

    Identification of key personals

    Composing URS

    Development of compliance achievement strategy:

      Risk Assessment
      System Components Categories Assessment
      Hardware / Software Suppliers Assessment
      Determination of System Life-Cycle Strategy

    Work Plan:

      Project realization plan
      Computer validation plan

    System specification:

      Functional Specification (FS)
      Configurational Specification
      Design Specification (DS)
      Design Review and Approval

    Development of procedures for operation:

      Handover of the system (SOP)
      Implementation of system maintenance and monitoring (SOP)
      Corrective and preventive measures (SOP)
      Change management (SOP)
      Audit (SOP)
      Backup / restore (SOP)
      System safety (SOP)
      Record management (SOP)
      System retirement (SOP)

Realization and testing (computer validation)

    Purchasing / installation of hardware:

      Purchasing
      Installation
      IQ
      Standard Firmware modification / control

    Purchasing / installation of standard software:

      Operational System
      Standard program package

    Development and review of program code:

      Development of strategy and principles
      Identification of software modules
      Development of software modules specifications (MS)
      Development of modules code
      De-bugging / cleaning module code
      Creating reference tables
      Program code review

    Development of testing documentation:

      Testing plan / strategy
      Testing protocols / specifications
      Testing descriptions / scripts

    System testing:

      Modules testing (MS)
      Integration testing (DS)
      Functional testing (FS)
      Performance testing (URS)

    Development of reports and release of the system:

      Testing reports
      Summary testing report
      Summary computer validation report

These services/activities can be realized with a different degree of participation of Pharma Group Baltic specialists, from conceptual assistance and consulting to full execution of work. Optimal division of responsibility is determined individually for each project.