FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations
This document provides to sponsors, contract research organizations (CROs), data management
centers, clinical investigators, and institutional review boards (IRBs), recommendations
regarding the use of computerized systems in clinical investigations
“Computer Crossmatch”
(Computerized Analysis of the Compatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type)
This guidance describes certain of the practices that FDA, believes satisfy the requirements in 21 CFR 606.151 to help ensure detection of an incompatible crossmatch when using an electronic based system for matching a donor's cell type with a recipient's serum or plasma type
FDA Guidance for Industry
Blood Establishment Computer System Validation in the User’s Facility
DRAFT GUIDANCE
This guidance addresses a blood establishment's validation of its Blood Establishment Computer System which incorporates Blood Establishment Computer Software (BECS). The BECS that is incorporated into a Blood Establishment Computer System may be manufactured either in-house or by a software manufacturer/vendor.
Eudralex Volume 10 Annex V GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Phase I Units
The purpose of this document is to provide guidance for the preparation of GCP inspections conducted in Phase I Units. The points to consider in this document are specific to these types of units and other guidance documents should be referred to
for consideration of those areas common to other types of inspections, e.g. computer systems, archiving and quality systems.
FDA COMPLIANCE POLICY GUIDE Sec. 425.100 Computerized Drug Processing; CGMP Applicability to Hardware and Software (CPG 7132a.17)
Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.
FDA COMPLIANCE POLICY GUIDE Sec. 425.200 Computerized Drug Processing; Vendor Responsibility (CPG 7132a.12)
Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.
FDA COMPLIANCE POLICY GUIDE Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs (CPG 7132a.15)
Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.