Software / Hardware

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Optional Requirement for Software/Hardware Control System

GAMP5 (Guide for Validation of Automated Systems)

  • The automation compliance to GAMP5 is autocertify from Comecer following a development sequence of the project called “Life cycle“; This autocertify is done by preparing the following documents, that describe the functional charateristic of the Hardware and the test for its validation:
    • FDS (Functional Design Specification)
    • HDS (Hardware Design Specification)
    • STS (Software Test Specifications)
    • HTS (Hardware Test Specifications)
    • Change Control

CFR21 part11 (Electronic records, electronic signatures)

  • The compliance of software to the regulation CFR21 part11 is autocertify from Comecer following a documented analysis of the regulation requirements; Comecer describes how this requirements are applied in software development. Also the requirements of CFR21 part11 are validated with a test protocol (STS Software Test Specifications).