CIMS will ensure your data integrity – All the way
CIMS works from the CenterPoint of data, information and processes in drug development. Our services are centred around data where we can support specialist, in-depth and cross functions as needed. We facilitate that data and processes are integrated and in regulatory compliance.
CIMS provides both consulting assistance as well as development and implementation of specific solutions.
CIMS focus is a holistic advice under Information Management where the entire value chain of information management, IT, QMS and the organisation is taken into account.
When CIMS is working with data integrity the main concepts are ISO 9001:2015 inspired risk-based thinking, Information Supply Chain Management (ISCM) and 3*T perspective (Truth-Trust-Traceability). Together these three main concepts hold the key to successful data integrity.
For each main concept we leverage five toolboxes of the data exchanges and processes.
- Map out vendor processes
- Identify data processes under exchanges
- Outline the needed information management
- Imbed information management this into clinical processes
- Ensure compliances via Audits QA/QC
The Toolboxes we use are multifaceted for ensuring compliances with statutory and regulatory requirements.
Bringing it all together the statutory and regulatory compliance is secured by combining CIMS three main concepts and using the appropriate tools from our toolboxes.
Setting Data Integrity as a goal gives our customers a new insight into processes which leads to a very efficient oversight of all integrated activities and deliverables.
What has made the differences for our customers?
Here are some of our customers statements describing the difference CIMS has made for them.
- Agile stability
- Lean data flows
- Domain expertise
- Agility in decisions
- Knowledge management
- Optimized vendor process
- Robustness of QMS ensured
- Internal process development
- Easy access to data and reusability
- Implement quality assurance on data
- Data and information with ensured statutory and regulatory compliances
What services do we deliver?
Beside securing data integrity we also deliver stand alone services like shown below. Please ask us for specific tasks not mentioned here.
- QMS Audits
- STAT Audits
- Advanced Analytic
- Change Management
- Post-Merger Integration
- Data Science Integration
- Data Management Audits
- Lean Process Development
- Project Management Services
- Data Management Development
Contact us today!
Let us help with your challenges. Contact us today to talk about what we can do for you!