Healthcare
Healthcare Document Management Solution
Based on the unique characteristics of the pharmaceutical and healthcare industry, closely adhering to core standardization and compliance requirements, leveraging information automation technology to comprehensively enhance the standardization, security, compliance, and efficiency of enterprise document management.
Challenges in the Pharmaceutical & Healthcare Industry
Establishing and implementing a complete quality management system is very time-consuming and resource-intensive, with complex management; there is a high demand for a complete document management solution that complies with GMP standards.
Document Management Challenges
- ✓ Large volume of information, difficult file access
- ✓ Difficult version control, challenging data traceability
- ✓ Complex offline file management processes
Process Management Challenges
- ✓ Difficulties in lean quality management
- ✓ Numerous obstacles in centralized quality management
- ✓ Significant gap between quality management levels and international standards
Compliance Challenges
- ✓ Data integrity cannot meet regulatory requirements
- ✓ Difficult to guarantee data compliance
- ✓ Difficult to ensure data consistency
Solutions
Based on internationally recognized pharmaceutical and related industry standards, such as GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), and GLP (Good Laboratory Practice), adopting advanced management concepts to build computer system validation services that comply with international and domestic GMP standards, supported by strict security management technologies and strategies.
Laboratory Data Management
Industry Pain Points
- ✓ GLP has strict requirements for laboratory data integrity (DI)
- ✓ Metadata generated by laboratory instruments needs to be reported and signed
- ✓ Data from different vendor instruments needs unified management
- ✓ Laboratory instrument SOP process execution lacks system constraints
Solutions
- ✓ Can interface with different laboratory instruments to capture and parse data in real-time
- ✓ Supports project task workflows, configurable according to user requirements
- ✓ Comprehensive audit trail information, full traceability of key actions
- ✓ Supports compliant data report signing, meeting regulatory audit requirements
Pharmaceutical Production Batch Record Management
Industry Pain Points
- ✓ Existence of compliance vulnerabilities and security risks
- ✓ Paper records are difficult to preserve, challenging to retrieve and review
- ✓ Low efficiency in offline blank record applications and record reviews
- ✓ Record filling and modification processes cannot be tracked
Solutions
- ✓ Configurable approval workflows, adaptable to different production strategies
- ✓ WYSIWYG online record form designer
- ✓ Comprehensive audit trail for record filling and modifications
- ✓ Strict user role and permission control
Training Management
Industry Pain Points
- ✓ Different training types require differentiated training plan solutions
- ✓ Training records need to be archived for inspection and audit
- ✓ Special circumstances (e.g., epidemics) make offline training difficult to implement
- ✓ Users have personalized training and examination requirements
Solutions
- ✓ Tightly integrated with document management system, can be used independently
- ✓ Rich training types with configurable workflows
- ✓ Complete recording of training and examination processes, Dashboard tracking
- ✓ Online exam creation with visual form configuration support
- ✓ Training reports and records are searchable, archivable, and support signing