Validation Services

SUPPORT FOR VALIDATION AND DOCUMENTATION

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