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Category: Electronic Record & Electronic Signature (ERES)

Electronic Records and Electronic Signatures (ERES) or 21-CFR-Part 11 refer to the principles and regulations governing the creation, maintenance, and use of electronic records and the implementation of electronic signatures in regulated industries. This framework is essential in sectors like pharmaceuticals, medical devices, and other fields where regulatory compliance is necessary, particularly when documentation is critical for safety, quality, and compliance.

Why ER/ES Is Required in Computer System Validation (CSV)

Computer System Validation (CSV) plays a critical role in regulated industries such as pharmaceuticals, biotechnology, and medical devices. Ensuring that computer systems perform as intended and comply with regulatory requirements is essential for product quality and patient safety. Within this process, Electronic Records (ER) and Electronic Signatures (ES) have become indispensable components. This post explores […]

USFDA 483 on Access Management of Computerized System

USFDA 483 on Access Management of Computerized System

Observation   1. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your firm manufactures over-the-counter (OTC) drug products, including alcohol-based hand sanitizers[1]. During the inspection of your facility, our investigator attempted […]