Description
We, FDA, are issuing this guidance to assist you, blood establishments, in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices. This guidance addresses a blood establishment's validation of its Blood Establishment Computer System (system) which incorporates Blood Establishment Computer Software (BECS). In the context of this guidance, the term user's facility means the blood establishment.
Scope & Applicability
Product Classes
2BECS is a medical device intended for use in blood establishments.; Specific software category subject to 510(k) requirements
The primary system being validated, often referred to as BECS
Stakeholders
2Entities that collect blood and blood components; Entities responsible for testing donations and complying with regulations.
Entity that develops the BECS and provides test cases
Regulatory Context
Attributes
2Established prior to transfusion by scanning barcodes.
Conditions representing maximum stress on the system, such as maximum users
Identified Hazards
Hazards
2BECS is intended to prevent the release of unsuitable blood.
High-risk function with potentially fatal consequences for transfusion
Related CFR Sections (6)
- 21CFR211.68§ 211.68 Automatic, mechanical, and electronic equipment.
(a) Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinelyRead full regulation →
- 21CFR606.100§ 606.100 Standard operating procedures.
(a) In all instances, except clinical investigations, standard operating procedures shall comply with published additional standards in part 640 of this chapter for the products being processed; except that, references in part 640 relating to licenses, licensed establishments and submission of materRead full regulation →
- 21CFR606.160§ 606.160 Records.
- 21CFR606.60§ 606.60 Equipment.
(a) Equipment used in the collection, processing, compatibility testing, storage and distribution of blood and blood components shall be maintained in a clean and orderly manner and located so as to facilitate cleaning and maintenance. The equipment shall be observed, standardized and calibrated on Read full regulation →
- 21CFR211.100§ 211.100 Written procedures; deviations.
(a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, inRead full regulation →
- 21CFR211.25§ 211.25 Personnel qualifications.
(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performsRead full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Medinatura New Mexico, Inc.
- 2025-12-16
CGMP/Finished Pharmaceuticals/Adulterated
Sklar Personal Care Inc.
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc.
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
CDL Services, Inc. DBA Technichem
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
Seaway Pharma Inc.
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
PQ Pharmacy, LLC
See Also (8)
- CPG Sec. 425.400 Computerized Drug Processing; Input/Output Checking (Status: Final)
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (Status: Final)
- The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP): Guidance for Industry (Status: Final)
- Process Validation: General Principles and Practices: Guidance for Industry (Status: Final)
- BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry (Status: Final)
- Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry: Guidance for Industry (Status: Final)
- Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for Industry (Status: Final)
- Development and Submission of Near Infrared Analytical Procedures (Status: Final)