Validation
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| Get Validated...and stay Validated! |
| DataCeutics will validate your systems to regulatory standards and DataCeutics will keep your system valid. |
| Our validation specialists can assist you in your project, from planning to management and everything in-between. We validate your system whether it be Oracle Clinical™, Oracle TMS™, Oracle AERS™, Oracle RDC™, Clintrial™, Clintrace™, Documentum™, SAS-based tools, or your custom application. We can use our own validation methodology (DMV) or your in-house methodology. |
Key components of the DataCeutics Validation Methodology (DVMsm)
data ceutics
- 21 CFR Part 11 System Assessment
- GAP Analysis
- Validation Protocol and Plan
- IQ, OQ, PQ Plan and Report
- Vendor Audit Questionaire
- User Requirements
- Traceability Matrix
- Packaged SOPs and Work Guidelines
- Packaged Test Script
- Final Validation Report
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| We have complete validation packages for |
| Oracle Clinical, Oracle TMS, Oracle RDC, Oracle AERS, Clintrial and Clintrace. |
DataCeutics has performed more than fifty computer systems validations of Oracle Clinical Products, Clintrial and Clintrace. |
