competence

in validation

FS, DS, CS, VP, VMP, TRM, SOP, IQ, OQ and PQ documentation creation

Logical GxP-conform standards in GAMP5-based documentation creation

FS - Function Specification

Clearly and fully specifies the programme function. FS-based subsequent tests.

DS - Design Specification

BURS-based and supplements it with detailed specifications of, for instance, the hardware/software to be used, test point lists and other particulars.

CS - Configuration Specification

Provides a detailed technical extension of the FS and specifies how the system fulfils its parameters. This configuration provides the basis for the following configuration management. Settings and parameters are maintained here.

VP - Validation Plan

Specifies how a certain system validation is to be implemented.

The more complex, risky and newer the system is, the more detailed must be the planning.

Example:

  • Which task is needed?
  • How is this to be carried out?
  • Who is responsible for it?
  • Which findings are to be obtained?
  • Which requirements are placed on acceptance?

VMP - Validation Master Plan

Specifies the company sectors where validation is a necessity and overviews the validation planning.

Example:

  • Overview of the facilities, systems, equipment or processes under consideration
  • Ongoing status
  • Schedule and time management

TRM - Traceability Matrix

Users need to prove they have examined the validation testing requirements. The TRM is designed for this examination.

SOP - Standard Operation Procedure

A detailed and logical description of the sequences is given.

IQ - Installation Qualification

Qualification to see that system components are installed in keeping with specifications (FS, DS, CS) and the local/global requirement. Qualification provides a verified basis for the following installations or changes.

OQ - Operation Qualification

Qualifies and documents the general working order. Calibrating intervals, maintenance and cleaning specifications are some of the findings laid down.

PQ - Performance Qualification

The user provides documentary proof of the required performances for a defined task under real conditions having been furnished on the basis of a PQ plan.