Quality Management
seQure is the business unit of Arithmos, related to Quality Compliance and Consulting Services.
With a quality-driven culture and customer-oriented service management approach, we offer advanced solutions for Quality and Compliance in all GxP areas (GMP, GLP, GVP, GCP), supporting individual client needs in finding the most effective solutions and services to meet regulatory requirements, reach their goals and improve processes.
Quality Compliance for GxP
We have created a network of experts with over 20 years of experience in the implementation of Quality Management Systems, Support for GxP audits and Computer System Validation. In addition, our team offers training courses on Quality Assurance & Compliance for our customers to support the organizational strategies and the quality management culture in their organization.
Services and Consultancy for Quality Assurance
- Quality Management Services: from process assessment to implementation, analysis and system improvement
- Standard Operating Procedures (SOPs), Quality Manuals, Policies: creating documents and tools to improve readability and compliance
- GxP Audits: from defining client processes to the planning, conducting and reporting
- Quality and Compliance in Pharmacovigilance: from system assessment to system and third-party audits
- Training: analysis and assessment of training needs
- GxP mock-inspections: preparation and post regulatory inspection support for remediation actions
- System and Database Audits, Software House Audits, Suppliers and Service Providers
Quality and Compliance for Pharmacovigilance
Our team has particular competence in quality and compliance solutions for Pharmacovigilance Systems ensuring PV processes and systems are compliant and your company is ready for PV Audits and Inspections.
Pharmacovigilance Audits and Inspection Readiness
- Preparation of Quality Manual, Policy, SOPs and Work Instructions
- Development of process mapping for PV systems
- Development & Management of KPIs
- PV Audit planning, conduct and reporting
- Development of CAPA (Corrective and Preventive Action)
- Support for identifying advanced compliance solutions
- PV and Quality Compliance consultancy
- Support for PV Inspection preparation
Quality Assurance for Phase I Units
We support you in achieving the Phase I accreditation and the full operational compliance according to Determina AIFA 809/2015. We have developed a lean model for obtaining Phase I accreditation and full operational compliance.
The efficiency of the model is reached by the application of a Lean Methodology that allows for achieving results faster by identifying value-creating steps and eliminating or reducing non-value-adding steps.
Step 1: Preparation Phase – Define and Measure
Step 2: Assessment Conduct Phase – Analyse
Step 3: Final Evaluation, Action Plan and Assistance for Implementation Phase – Improve and Control
Our Phase I package includes
- Assessment of the current Phase I Unit status
- Gap analysis to evaluate missing requirements
- Revision of the existing processes and their optimisation, creation of the missing one
- Creation of necessary general SOPs, Clinical Unit SOPs, Laboratories SOPs
- Computer System Validation
- Support in the implementation of the new processes
- GCP QA Manager – internal QA role
- Qualified auditor according to Determina
- Internal GCP training to Phase I stuff
Why us?
Experience
Consolidated experience in supporting 10+ Phase I Units in obtaining the certification
Power of Technology
We are ISO 27001 certified. Get access to the latest technology to streamline your QA processes
Unique Lean Approach
Increase not only compliance but also efficiency. Benefit from the process improvement through eliminating the waste and adopting technology with our unique Lean approach
Certified Auditors
Get access to the network of our certified experience auditors available to support you on your road to successful certification
Learn More About Determina AIFA 809/2015
According to Determina AIFA 809/2015, any clinical research unit conducting Phase I trials in Italy is obliged to comply with a series of standards to obtain accreditation. These standards include:
Facilities
Clinical facilities should be appropriately controlled and allow that study subjects to remain there for supervision during and after dosing as required by the protocol. All laboratories’ equipment and computerised systems should be validated according to the applicable regulation.
Staff
All units should have qualified staff for resuscitating and stabilising individuals in an acute emergency. Moreover, it is important that investigators and medical staff is trained appropriately. Their training should include not only relevant medical expertise but also knowledge of GCP.
Procedures
All units and laboratories should have written, authorised procedures and should update them in accordance with the last version and remove obsolete versions from circulation.
At seQure, we offer a complete package of Quality Assurance services to guarantee compliance of Phase I Units and their laboratories with the requirements described in Determina AIFA n. 809/2015.
