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Validation Services


All Oasis network system products incorporate functions as per regulatory guidelines and computerized validation functions required by GXP. Oasis provides full documentation including IQ/OQ, Certificate of compliance, and inspection test result reports based on certified system. Oasis total solution for Pic/s, GMP, FDA 21 CFR Part 11 and computerized validation – establishes proof for reliability and security built in the system. Systematic validation support for creating system operation and management procedures required for FDA compliance by providing ready to use DQ / OQ / OQ computer validation templates.

Validation support

Oasis offers validation and documentation assistance to customers on the basis system configuration in accordance preparation of documents in such a way that relevant and applicable parameters of V-model life cycle are followed appropriately as a standard.

Following documentation shall be prepared specific to OasisLIMS project:

  • Project plan including training plan / training logs, System concept including risk analysis, Hardware design / requirement specifications

  • User requirement specification, Functional specifications, Traceability matrix (against URS, FS)

  • Software installation acceptance testing including network qualification Traceability matrix (against IQ)

  • Manuals / SOP’s

  • System / user acceptance testing

  • Test protocol results

  • Problem resolution forms

  • Operational / performance qualification report

  • Traceability matrix (against OQ/PQ)

  • Validation report and summary, Certificates