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Excel Sheets Development & Validation
Excel Sheets Development & Validation
Excel sheets will be designed and validated based on user and regulatory requirements. The features include formula design, Formula verification, cell lock, Excel protection, Audit Trail Logs, and more.
Laboratory-Software Computer System Validation
Laboratory-Software Computer System Validation
Laboratory Software: Chromeleon, Lab Solutions, Open Lab CDS, Empower, Tiamo, UVprob, MicroLab, Qtegra, TOC-L (HPLC, LC, LCMS, GC, GCMS, UV, Karl Fisher, FTIR, LPC, ICPM, ICP-OES, more instrument)
ERP, LIMS, QMS, Customized-URL Based Application
ERP, LIMS, QMS, Customized-URL Based Application
ERP: GxP Module (Master Process, Production Management Process, Quality Control Process, Negative and Positive Challenges, Verification Whole Process Flow
Computer Systems Validation Services are based on the following approaches:
Risk-based approach
Approach based on the life cycle of the system
Approach on “V”-model for development and system test
An approach based on the process that serves the system
Approach to the GAMP category system
Food and Drug Administration (FDA)
“Validation is the confirmation by objective evidence, that the previously established requirements for the use of a process or system are met.”
WHO guidance on the requirements of (GMP)
“Establishment of documentary evidence that provides a high degree of assurance that a planned process will be uniformly in accordance with the expected specified results.”
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