QA Compliance
Industry authority in computer system validation & systems compliance
DataCeutics is an industry authority in GxP electronic systems’ QA and compliance. In client engagements, DataCeutics implements best practices.
Electronic systems are critical in the development and support of your drug products. DataCeutics Validation Methodology (DVM) ensures that computer systems are planned, designed, developed, tested, installed, operated, maintained, and archived according to regulations and acceptable industry and Company standards.
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 a life-cycle Development Methodology, Functional Requirements Specifications, Design, Test Protocols, Traceability Matrix, Test Scripts, Test Results, Validation Summary Reports, and complete SOPs covering all phases of application development, support and maintenance.
Our staff can write all of the required documentation to demonstrate control over your data and electronic systems. We have worked with hosted applications, SaaS applications, manufacturing, LIMS, and clinical systems. Major systems validated include regulatory, clinical, laboratory, serious AE, among others. We used a risk-based approach to your validation & testing needs. This saves time and money.
Key components of the DataCeutics Validation Methodology (DVM)
- Risk Assessment
- 21 CFR Part 11 System Assessment
- GAP Analysis
- Validation Protocol and Plan
- IQ, OQ, PQ Protocols and Reports
- Vendor Audit Questionnaire
- User Requirements
- Traceability Matrix
- SOPs and Work Guidelines
- Test Script Authoring and Execution
- Final Validation Report
Always looking for the very best talent, we offer an excellent benefits package and many opportunities to advance your skills >> more
We have the experience you need to get the results you want since many of our team members have an average of 15 to 20 years in the clinical data environment. >> more
Following our proven methodology, DataCeutics provides leadership at the audit or support depending upon your need. We examine every aspect of a vendor from quality process, SOPs, training, logical and physical security, IQ, OQ, PQ documentation through regulations and compliance. We can provide follow-up, ongoing or first-time audits, too.
Our team of experts is well-versed in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations and can hit the ground running with as little as 1 week advance notice!
Our highly experienced team of QA professions can serve as your QA for a project, process or site. We will plan and implement your QA process. We can also train and prepare your staff to serve as QA professionals. and provide regular QA reviews of your processes, and projects.
Our services are efficient, effective and very professional. We are ready and eager to help you fulfill your QA requirements.
• Environment Assessments
• Gap Analysis
• Validation Project Management
• Unit, Integration, & System Testing
• Vendor Audits
• Installation Qualifications (IQ/OQ/PQ)
• Validation Documentation
• User Requirements Specifications
• Script Authoring/User Acceptance Testing
• Regulations/GxPs/21 CFR Part 11 Training
• Compliance Assessments
• Vendor Audits
• Business Process Consulting
• SOP Development
• Systems Selection & Implementation
• Validation
• Clinical Study Report Audits
OUR COMPREHENSIVE CAPABILITIES INCLUDE:
- Biostatistics
- SAS® Statistical Programming
- SAS® QC/Verification/Validation
- Protocol Deviation Programming
- SAS® Verification Programming
- Clinical Reporting Tools
- SAS® Systems Development
- Systems Development Life Cycle Methodology
- IEEE Development Methodology
- Standards Implementation
- CDISC CDASH/STDM and ADaM Services
- Electronic Submissions
- Statistical Computing Environment Support
- IT Environment Support
- Clinical Study Report Auditing
- QA
- Regulations/GxPs/21 CFR Part 11 Training
- Compliance Assessments
- Vendor Audits
- Business Process Consulting
- SOP Development
- Systems Selection & Implementation
- Validation
- Test Scripts
- User Acceptance Testing
- Electronic Data Capture (EDC) System Support
- Clinical Programming
- Edit Check Programming
- Data Entry Support
- Clinical Data Management Support
- Medical Writing
