Quality Services
With our international network of qualified auditors, a quality-driven culture and a customer-oriented service management approach, Arithmos offers pragmatic solutions for Quality and Compliance in all GxP areas (GMP, GLP, GCLP, GVP, GCP).
We support your team in implementing the most effective solutions and services to meet regulatory requirements (AIFA, EMA, MHRA, FDA), and reach your quality objectives by improving processes.
Quality Assurance requires in-depth knowledge of processes, and if utilised effectively, can deliver a continuous cycle of improvement in Quality.
Our philosophy is one of teamwork, proactivity and adding value.
Our highly qualified GxP specialists provide expert Quality Assurance audits and consultancy to pharmaceutical, biotech and medical device companies globally, in line with the relevant best practices, regulations and quality guidelines.
Audits
Our international network of experienced and qualified auditors is available to assess your GxP compliance, support your audit requirements and help you reach your quality goals.
Our audit team is composed of highly experienced GxP specialists, with a detailed understanding of the nuances between local regulatory bodies, including AIFA*, EMA, FDA and MHRA.
We support your company in executing audits in a timely and efficient manner, allowing virtual activities to cut costs when on-site visits are not allowed.
- GCP, GMP, GLP, GCLP, GVP Audits: planning, conducting and reporting
- IT, CSV and eTMF Audits
- QP Audits
- Mock Inspections
- Internal Audits
- Supplier qualification audits
In addition, our team offers training courses on Quality Assurance & Compliance for our customers to support their organisational strategies and the quality management culture in their organisation.
*For Italian companies : D.M. 15 novembre 2011 | Definizione dei requisiti minimi per le organizzazioni di ricerca a contratto (CRO) nell’ambito delle sperimentazioni cliniche di medicinali (Pubblicato nella Gazz. Uff. 14 gennaio 2012, n. 11).
Quality Assurance Consultancy
We provide proactive QA consulting in order to support the re-design, optimisation and digitalisation of quality processes, including feasibility studies and software selection services.
With extensive experience across the GxPs, we provide expert knowledge and guidance in support of your quality goals.
Our consultancy services are bespoke to your requirements; from documentation and process reviews to risk management and strategic consulting, our QA experts operate as an extension of your internal team.
QMS Development
The development and maintenance of a robust Quality Management System is fundamental to ensuring compliance with good practice quality guidelines and regulations.
We provide Life Sciences companies with full support in setting up, managing, delivering and validating QMS.
Our personable, knowledgeable team provides GAP analyses, process mapping, and the development of a tailored set of policies and procedures that are simple, practical and phase-appropriate, facilitating effective operation in all areas.
Our team will ensure your Quality Management System is inspection ready, meeting the requirements of the applicable Regulatory Authorities and fulfilling your obligations for sponsor oversight.
We also provide digital solutions for QMS and Digital Validation, selected, integrated and configured for your needs.
eQMS Integration
The implementation of eQMS software can help your company to maintain the highest level of quality and compliance, reduce costs, increase efficiency, mitigate errors and make informed decisions to deliver safe and effective products to patients.
However, an eQMS solution must be carefully selected and validated in order to ensure the software is fit for its intended use, and to realise the full benefits of the technology. eQMS software validation is the process of verifying the suitability and proper implementation of an electronic quality management system (eQMS) solution. The process will typically begin with a vendor audit, followed by installation, operation and performance reviews. Our impartial specialists will ensure that your chosen software:
- meets the applicable regulatory standards (including FDA, EMA, MHRA)
- is appropriate for the sector and scale of your organisation
- has been properly installed and integrated with your existing systems
- is reliable, accurate and is operating optimally
- is provided by a low-risk, trust-worthy vendor
Combining our expertise in technology and quality services, we support you in streamlining system adoption, implementation, and validation.
Inspection Readiness & Mock Inspection
We provide inspection preparation training, mock interviews and GxP mock inspections to identify any potential findings from a regulatory inspection.
We also support your internal team with any remediation and training.
Our QA team has extensive experience preparing for, participating in, managing and hosting AIFA, MHRA, EMA and FDA inspections.
QP Services
For batch releases and manufacturing sites in the EU and UK, Arithmos customers benefit from access to our in-house, EU and UK licensed Qualified Person.
In order to ensure batches, meet regulatory standards, we provide bespoke consultancy, conduct site audits, and review batch documentation for release.
Our QP audits and batch reviews are supported by our QA auditing team both on and off-site.
Why us?
Qualified Auditors
Get access to our international network of experienced auditors available to support your audit requirements and quality goals.*
Experience
Consolidated GxP experience since 2004, including supporting 6 out of the 10 biggest pharma worldwide.
Knowledge
Our QA specialists have direct, hands-on experience, offering a real-world insight into the role. We actively monitor updates to GxP guidelines and regulations, and this knowledge is passed on to our customers.
Power of Technology
We provide a holistic competence and approach across multiple domains (GxP compliance, operational excellence, technology) and we are ISO 27001 certified. Get access to the latest technology to streamline your QA processes.
Lean Approach
Increase not only compliance but also efficiency. Benefit from improved processes, eliminating waste and efficient technology with our Lean approach.
*For Italian companies: D.M. 15 novembre 2011 | Definizione dei requisiti minimi per le organizzazioni di ricerca a contratto (CRO) nell’ambito delle sperimentazioni cliniche di medicinali (Pubblicato nella Gazz. Uff. 14 gennaio 2012, n. 11).
A strong network of Partners
With our network of Partners and our extensive expertise, we support you to adopt the right solutions and services to meet regulatory requirements and reach your quality objectives by improving processes.
Background to our Quality Assurance team
seQure, based in Italy, was founded in 2014 by our CEO Paolo Morelli, providing consultancy and services in Pharmacovigilance, Quality Assurance and Regulatory Affairs. The company became one of the outstanding providers in the Life Sciences industry.
In July 2022, we successfully merged Arithmos and seQure, with the mission to become a Strategic Partner providing end-to-end services for our customers.
The CQA Company, formed in 2004 and acquired by Arithmos in November 2022, is based in the UK and operates under the guidance of an EU and UK licensed QP.
The CQA Company specialises in GCP and GMP audits and consultancy, along with QMS development and QP services.
Our QA experts across both units work collaboratively to share industry knowledge and provide our clients with a global network of experienced auditors across all GxPs.
