Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959

Validation of Computer System Used in Production and/or Quality Systems

1. Service Description

This service provides complete validation of all core infrastructure computer systems used in production and/or quality systems. Based on an understanding of how software is built, the service documents a process for ensuring quality in business applications, managing the risks associated with potential system failures, and meeting the regulatory requirements for software validation. Emphasis is placed on the common deliverables for computer system validation efforts such as requirements, validation plan, vendor qualification, risk assessment, test protocols, and protocol reports.

There will be productivity increase and cost savings of more than 80% using our service. Your company will save money from several thousand to millions of dollars adding to your bottom line profit.

The V Model for Computer System Validation

Figure 1 - The V Model for Computer System Validation

2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our service based on the company size is provided in the Table 1.0.

Projected savings is based on

  1. Process efficiency gains (people)
  2. Less personnel requirements (people)
  3. Infrastructure efficiency gains (systems)
  4. Infrastructure validation and maintenance (systems)
  5. Delivering quality products
  6. Avoid regulatory noncompliance cost
  7. Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size Small Medium Large
$Savings > 40 % > 60 % > 80 %
Annual Sales < $100 million $100 million < Sales < $500 million > $500 million
Number of Submissions <= 2 per year 2 < Sub <= 4 per year > 4 per year

Table 1.0 - Amount of money saved by your company on using our service. Company size is based on annual sales as per FDA classification.

3. Solution Approach

Our validation approach of computer system used in production and/or quality systems is as follows:

  1. Document Schedule for Validation Activities
  2. Document Validation Resources and Responsibilities
  3. User Requirements Documentation and Review
  4. Quality Plan Documentation
  5. Risk Identification, Analysis and Management
  6. Validation Plan Documentation
  7. Internal User Testing
  8. Validation Protocol Planning Table Creation
  9. Criteria for Validation Entry
  10. Tools, Techniques and Methods
  11. Validation Environment
  12. Validation Protocol Execution
  13. Pass / Fail Criteria
  14. Validation Deviation Management
  15. Validation Protocol / Report List and Status
  16. Validation Summary Report

Validation key phases are listed below

  1. Design Qualification
    URS/FRS/Vendor Qualification
  2. Installation Qualification
    Check arrives as purchased
    HW/SW installed
  3. Operational Qualification
    Test key operational functions
    Test security functions
  4. Performance Qualification
    Test specified application
    Preventive maintenance
    Ongoing performance

The V Model Mapped to IQ, OQ and PQ

Figure 2 - The V Model Mapped to IQ, OQ and PQ

Products Validated

  1. ERP JDE , SAP, Oracle etc.

  2. Document Management System

  3. Change Order System

  4. NCMR, Deviation and CAPA System

We have regulatory ISO/QSR validation products for following software's:

  1. SAP

  2. Oracle

  3. J.D. Edwards

  4. Salesforce

  5. Argus

  6. Plateau LMS

  7. TrackWise

  8. Documentum

  9. QAD

  10. BPCS  

  11. PRMS  

  12. Agile PLM

  13. SQL LIMS

4. Definitions

Software Validation. Determination of the correctness of the final program or software produced from a development project with respect to the user needs and requirements. Validation is usually accomplished by verifying each stage of the software development life cycle (NBS).

Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled (FDA).

Software Verification. In general the demonstration of consistency, completeness, and correctness of the software at each stage and between each stage of the development life cycle (NBS).

Provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase (FDA).

Software Design, Development and Testing Process

Software development is a process by which user needs are translated into a software product. The process involves translating user needs into software requirements, transforming the software requirements into design, implementing the design in code, testing the code, and then installing and checking the software for operational activities. These activities may overlap or be performed iteratively. Some of the development models are as below:

  1. Agile Software Development: Agile software development is a conceptual framework for software development that promotes development iterations throughout the life-cycle of the project. Each iteration passes through all the software phases. Refer to Agile Alliance -  for details.
  2. Rapid Application Development (RAD): It is a methodology for compressing the feasibility analysis, planning, design, build, and test phases into a series of short, iterative development cycles. Refer to book by James Martin: Rapid Application Development, Macmillan for details.

    Rapid Application Development

    Figure 3 - Rapid Application Development
  3. Spiral model or Evolutionary Development: A model of the software development process in which the constituent activities, typically requirements analysis, preliminary and detailed design, coding, integration, and testing, are performed iteratively until the software is complete. Refer to IEEE-1074-2006 standards for details.
  4. V-Shaped Model: Just like the waterfall model, the V-Shaped life cycle is a sequential path of execution of processes.  Each phase must be completed before the next phase begins.  Testing is emphasized in this model more so than the waterfall model though.  The testing procedures are developed early in the life cycle before any coding is done, during each of the phases preceding implementation. Refer to IEEE-1074-2006 standards for details.
    V Shaped Validation Model
    Figure 4 - V-Shaped Model
  5. Waterfall Model (IEEE): - A model of the software development process in which the constituent activities, typically a concept phase, requirements phase, design phase, implementation phase, test phase, installation and checkout phase, and operation and maintenance, are performed in that order, possibly with overlap but with little or no iteration. Refer to IEEE-1074-2006 standards for details.

    Waterfall Development Model

    Figure 5 - Waterfall Model

5. Applicable Laws, Regulations and Standards

  1. Food and Drug Administration, CDRH. (1997). Title 21 CFR Part 11 Electronic Records; Electronic Signatures;
  2. Off-The-Shelf Software Use in Medical Devices -
  3. General Principles of Software Validation; Final Guidance for Industry and FDA Staff –