Systems Compliance Services
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DataCeutics is an industry authority in computer system validation and systems compliance.
In clients engagements, DataCeutics implements best practices in computer systems compliance. |
| Validation and 21 CFR Part 11 compliance are critical elements in the development and support of our software products and services.DataCeutics Validation Methodology (DVMSM) ensures that computer systems are planned, designed, developed, tested, installed, operated, maintained, and archived according to regulations and acceptable industry and Company standards. |
| Our Systems Compliance Services group is one of 3 service lines within DataCeutics. Many of DataCeutics Systems Compliance consultants are recognized industry authorities in validation and 21 CFR Part 11 in the clinical research environment.Our experts publish; are active in industry presentations and organizations; and perform all activities in the validation process ranging from assessments, strategy development, audits, planning, management, execution, acceptance of the system and final validation report. |
DataCeutics recognizes that Sponsor Companies and end-users are ultimately responsible for systems validation. DataCeutics acknowledges its important role in the clients validation process by supporting and providing clients with a complete, vendor-supplied validation package. This documentation includes DataCeutics life-cycle Development Methodology, Functional Requirements Specifications, Design, Test Plans, Traceability Matrix, Test Scripts, Test Results and complete SOPs covering all phases of application development, support and maintenance.
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