Electronic Data Integrity
How confident are you in the integrity of your data across its entire lifecycle?
Have you fully assessed the risk of data breaches and their impact on patient safety and product quality?
How prepared is your team to handle a regulatory inspection focused on data integrity?
How do you validate the software and systems handling your sensitive data for compliance?
Partner with qointa for Confidence in Compliance.
Advancing Life Sciences Compliance: Strategies for Validation, Qualification, and Operational Excellence
In the rapidly evolving Life Sciences sector, regulatory compliance, system validation, and operational integrity are not just regulatory requirements—they are foundational pillars that ensure product quality, patient safety, and competitive edge.
By partnering with us, you gain access to comprehensive solutions that mitigate risk, streamline processes, and maintain a state of continuous compliance. This is not just about meeting today’s standards; it’s about equipping your organization for tomorrow’s innovations, ensuring that your systems are robust, your operations are efficient, and your compliance is unwavering. In an industry where excellence is the minimum standard, our services are your strategic advantage, fostering a culture of quality and integrity that resonates through every facet of your operations.
Our suite of services, encompass:
-
GAMP5 and FDA 21 CFR Part 820 QSR-based QMS
Comprehensive, easy-to-follow SOPs, policies and tools for FDA compliance
Initial deployment / harmonization
Scalable “As-Needed” approach
Integration with client’s current quality system
QMS maintenance activities from periodic reviews to updates to ongoing training
QMS expansion due to organizational growth and changes
Periodic Audits/Assessments
Preparation and training for Audits
Representation during Audits
Full closure of Audit findings
-
Risk-Based CSV framework (GAMP5) development
Validation and Quality planning
Requirements development and management
Technology and vendor evaluation
Design and code reviews
Qualification/Testing efforts (IQ, OQ, PQ), from planning to script authoring, to execution, to defect documentation and resolution
Risk assessments and management
Defensible documentation for entire system lifecycle
Configuration and Change Controls
SOPs development and roll-out
Validation training
Service Level Agreements
Disaster Recovery planning and testing
Periodic Review of current system compliance and validated state
Hands-on leadership and implementation
We have an expertise to offer CSV services across a diverse system and technology portfolio, including:
eClinical systems, including Clinical Trial Management (CTMS), Clinical Data Management (CDMS), Electronic Data Capture (EDC), electronic Patient Reported Outcome(ePRO)/electronic Diary (eDiary), electronic Trial Master File (eTMF), pharmacovigilance and drug safety, Clinical Data Warehouse, etc.
Laboratory Data Acquisition and Information Systems, including LIMS, Electronic Lab Notebook, Chromatography, Mass Spectrometry, Scientific Data Management, laboratory equipment, etc.
Manufacturing Process Control Systems
Manufacturing Execution Systems
Quality Workflow and Document Management Systems
Enterprise Resource Planning Systems
Cloud based systems
Service-Oriented Architecture and Middleware based systems
Medical Device software
Custom software
IT Infrastructure
-
Part 11 Compliance Audits / Gap analyses and Risk analyses
Remediation planning and implementation
Establishing full Compliance
Part 11 technical controls
Part 11 procedural controls
Data Integrity controls across the record lifecycle
Part 11 training at “as needed” level of detail, from overview to highly detailed
Specific data integrity techniques to master
Mock Part 11 inspections and gap analyses
-
Infrastructure compliance assessments
As-Built and To-Be Design
Prospective/retrospective qualification:
Qualification of the Data Center
Qualification of the hardware and layered software
Qualification of the network and its components
Qualification of the data storage solutions
Qualification of the data backup, recovery and disaster recovery mechanisms
Establishing security procedures and security measures
On-going maintenance of controls and Guidance
Full program implementation
ASTM E2500 and GAMP principles
Download our Service Leaflets: