Quality Assurance and Compliance
Quality Policy
ClinPhone is committed to continually improving business performance and delivering the highest quality products to our customers.
We strive to achieve the highest standards of quality, compliance and integrity throughout our business and in the software and
services we deliver.
At ClinPhone, we instill the value of our high standards in every employee and all members of our team understand and believe in
our commitment. We have developed a Quality Management System to ensure a consistently high level of quality, which meets or exceeds
all relevant regulations and standards. Regular monitoring of our System ensures that all members of our staff continue to work in a
manner which conforms to our quality and compliance standards.
Quality Assurance Department
ClinPhone’s Quality Assurance (QA) department is independent of all operational processes and reports directly to the Chief Executive
Officer. Members of the QA team have extensive experience supporting the pharmaceutical and medical device industries, as well as
working with regulatory agencies. The QA team is directly responsible for all aspects of quality and compliance within the Company,
including coordinating client audits, performing internal and system audits, reviewing all required regulatory documentation
(Standard Operating Procedures, validation and software development), overall management of the corrective/preventive action process,
and delivering training to all staff in quality and regulatory-related activities.
Quality and compliance is assured through the review and approval of all critical processes at ClinPhone. Quality control is built
into ClinPhone's working practices through in-process checks and verification of client projects. ClinPhone successfully controls
internal processes across its broad customer base, while taking into account the variability of client-specific requirements.
Regulations and Compliance
ClinPhone’s processes incorporate extensive experience with regulatory standards and guidelines, which include:
- ISO 9001: 2000 and TickIT certified
- US FDA: Title 21 CFR Part 11, Electronic Records and Electronic Signature
- US FDA: Guidance for Industry for Computerized Systems used in Clinical Systems
- US FDA: Title 21 CFR on Good Clinical Practices
- EU Directives 2001/20/EC and 2005/28/EC on Good Clinical Practice
- UK MHRA: The Medicines for Human Use (Clinical Trials) Regulations
- International Conference on Harmonization (ICH) Good Clinical Practices
- Clinical Data Interchange Standards Consortium (CDISC) and Health Level 7 (HL7)
- Data Protection expectations as outlined in UK Data Protection Act 1998, EU Directive 95/46/EC and US HHS Title 45 CFR
Parts 160 and 164
