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SERVICES  SERVICES  :   ‐  Computerized System Validation  (CSV)   ‐  Backup & Disaster Recovery System   ‐  Network Support   ‐  Hardware Support Cumputerized System Validation Validation is an essential part of GMP, and an element of QA Basic principles include: => Safety, quality and efficacy of products => Built into the product – as it cannot be "inspected or tested into a product” => Critical steps in the process need to be validated Cumputerized System Validation including : ‐»System Specifications(Control document)      » In place, stating:   – objectives of a proposed computer system   – the data to be entered and stored   – the flow of data   – how it interacts with other systems and procedures   – the information to be produced   – the limits of any variable   – the operating programme and test programme     » System elements that need to be considered in computer validation include:   – hardware (equipment), software (procedures) and people (users) ‐» Functional Specifications:     » Provide instructions for testing, operating, and maintaining the system,           names of the person(s) (development and operation)      » When using computer systems, consideration: location, power supply,          temperature, magnetic disturbances      » GMP requirements for computer systems: Verification and re‐validation,Change           control, Checks(Data checked periodically, Confirm accurate and reliable transfer) ‐» Security      » Production as well as in quality control      » Data entered or amended  ‐ authorized persons      » Security systems to prevent unauthorized entry or manipulation of data      » SOPs for entering data, changing or amending incorrect entries and creating              back‐ups      » Security procedures in writing      » Audit trail: identify the persons who made entries, identify the persons who made            changes, identify the persons who released material, identify the persons who           performed other critical steps in production or control
Computer System Validation (2)  � Entry of critical data by an authorized person        � Independent verification and release for use by a second authorized person        � SOPs for certain systems or processes validated � Backups      � Regular back‐ups of all files and data          ‐ Secure storage (prevent intentional or accidental damage) � Validation (Planning, Validation policy, Project plan and SOPs):        �Hardware:          ‐ Appropriate tests and challenges to the hardware          ‐ No influence of static, dust, power‐feed voltage fluctuations and              electromagnetic interference          ‐ Focus on location, maintenance and calibration as part of the qualification       �Software:  ‐ is the term used to describe the complete set of programmes used by a      computer, and which should be listed in a menu ‐ Records are considered as software ‐ Focus should be placed on: accuracy, security, access, retention of records,    review, double checks, documentation and accuracy of reproduction ‐ Identification of authorized personnel: to write, alter or have access to     proggrames ‐ Key computer programmes to be identified: language, name, function, input,     output, fixed set point, variable set point, edits, input manipulation and program    overrides. Home Our Clients Products About Contact US Technology
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