Computer system Validation

Electronic Record & Electronic Signature Basic Concepts of Electronic Record & Electronic Signature in Pharmaceutical Industry Handwritten Signature: A scripted name or legal mark created by an individual that is unique to that individual and is used to authenticate something in writing. Digital Signature: A type of electronic signature that includes a way of verifying the identity of the signer, the validity of their signature, and the integrity of the record they signed. Electronic Record: Information in a digital form that is created or used in some way by a computer system. Electronic Signature: A set of symbols that is as unique and legally binding as a handwritten signature, but that is used to sign records in a computer system. Any time an electronic record is signed, the following information must be visible and associated with the signature: • Printed name of signer • Date and time of signature • Meaning of signature (e.g.,

Data Integrity Basic Concepts of Data Integrity in Pharmaceutical Industry What is Data? Facts, figures and statistics collected together for reference or analysis. All original records and true copies of original records, including source data and metadata and all subsequent transformations and reports of these data, that are generated or recorded at the time of the GXP activity and allow full and complete reconstruction and evaluation of the GXP activity. Data should be: A - Attributable to the person generating the data L – Legible and permanent C – Contemporaneous O – Original record (or true copy) A - Accurate What is Raw Data? Raw data is defined as the original record (data) which can be described as the first-capture of information, whether recorded on paper or electronically. Information that is originally captured in a dynamic state should remain available in that state Metadata: Metadata is nothing but data about data which g

Computer System Validation Basic Concepts of Computer System Validation in Pharmaceutical Industry What is Computer System? Computerized systems are the system which used extensively to capture, analyze, store data, report information and to control equipment and processes in life sciences industry. Software Validation Provision of objective evidence that software specifications conform to user needs and intended uses and that the particular requirements implemented through software can be consistently fulfilled Computer System Validation Cycle 1.      Validation Plan 2.      User Requirements Specifications 3.      Functional Specifications 4.      Design Specifications 5.      System Developments 6.      Installation Qualification (IQ) 7.      Operational Qualification (OQ) 8.      Performance Qualification (PQ) 1. Validation Plan The plan typically describes work to be done, resources required, methods to be used, configuration man