Quality Assurance Services

QMS

The Quality Management System (QMS) underpins every stage of a product’s life cycle, from clinical development through to Marketing Authorisation and beyond, and so a robust QMS is critical in order to achieve and maintain compliance. Agos Pharma can review your existing QMS or support you with implementing a new one to meet your business needs and Regulatory requirements.

eQMS

Are you finding managing the different parts of your QMS increasingly difficult? In such a heavily regulated industry, maintenance of the QMS can place a significant burden on companies. We can partner with our AgosIT* colleagues to design and host an Electronic Quality Management System (eQMS) configured to your requirements, or if you prefer an in-house solution we can help you select, configure, implement and validate your own eQMS.

*Our sister company, AgosIT offers bespoke, globally accessible, outsourced IT solutions to Pharmaceutical, Biotech, CRO and Healthcare organizations. They can assist with choosing, deploying, running and expanding technology needs, while keeping regulation, data integrity and compliance requirements at the centre of the solution design.

Gap Analysis

Agos Pharma can review your existing QMS to determine areas of deficiency. We can provide you with expert guidance to address any issues, suggest process improvements and/or prepare Standard Operating Procedures (SOPs) to ensure continued compliance with Regulatory requirements.

Training

Effective and regular training is fundamental to individual and team development. Agos Pharma can provide flexible training solutions from on-site courses to remote sessions (live and recorded).  Examples of areas we can cover are given below, please get in touch to discuss your team’s training needs:

  • Good Clinical Practice (GCP)
  • Good Pharmacovigilance Practice (GVP)
  • Regulatory Inspection readiness

Auditing

Our team are experts in conducting QMS and process audits, across all areas of GCP and GVP. We can conduct on-site or remote audits. We can conduct qualification audits as part of our vendor selection service, or to support your vendor selection process, and third-parties audits to ensure compliance with contracts and agreements.

Vendor Selection and Oversight

Choosing the right vendor is critical and a formal selection process is key; vendors providing good quality services help you to ensure that your company meets its legislative requirements. Agos Pharma can assist at all stages of the vendor selection process, from developing selection criteria, pre-selection and qualification auditing, to contract development and negotiation.

We can provide a management service to ensure that your company has oversight of vendor activities which is particularly important for clinical trial sponsors.

Regulatory Inspection Preparation and Support

Regulatory Inspections can be daunting, especially if it is the first time your company is being inspected. Our experts have been involved in a number of inspections, conducted by several EU Authorities, including the EMA, and can provide your team with inspection readiness training to help you prepare. We can provide support before and during inspections, providing extra resource remotely or on-site when you need it most. We can assist with drafting responses and Corrective and Preventive Action plans to address inspection findings.

Corrective and Preventive Actions (CAPA) Management

CAPA, arising from process deviations, audits or Regulatory Inspections are an important part of the QMS.  We can help you design an efficient CAPA process, including root cause analysis and trending, or our experts can provide CAPA management services for your company.


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