Quality Assurance

We support your projects all along the lifecycle of the products to ensure compliance with the quality requirements in a worldwide range.

QUALITY ASSURANCE

Quality Assurance refers to the systematic and planned set of activities, processes and methodologies implemented to ensure the safety, efficacity and compliance of products or services.

In Life Sciences industry, where precision, safety and accuracy are of the highest importance, Quality Assurance plays a significant role in maintaining the integrity and reliability of processes. This requires a rigorous quality system, adherence to best practices and continuous improvement.

Our team of highly skilled consultants is dedicated to supporting your company achieve excellence by ensuring the highest standards of quality in all your activities in the following domains :

Pharmaceutical

Food

Biotech & Vaccines

Medical devices

Veterinary

Cosmetic

Quality Assurance System

Aixial Group provides expertise within the QMS from the documentation management to the inspection readiness.

Process management

Assess current processes, identify gaps to improve using standardized methodologies,
Conduct process creation or update following changes (i.e. activities or regulatory updates, etc.),
Conduct implementation of new / updated processes,
Create communication material to clarify overview and manage change management,
Define related metrics and follow corresponding actions

Quality Documentation Management

Develop Standard Operating Procedures, Working Instructions and Supporting Documents using templates and writing good practices, in collaboration with subject matter experts from related departments/entities,
Manage process maps,
Provide appropriate quality documentation strategy,
Help simplification strategy of QDs,
Manage QDs life cycle, including review & approval,
Quality Control of QDs,
Gap analysis.

Training Management

Develop / update training material,
Manage training assignation,
Follow training reporting and compliance with indicators

Change Management

Accompaniment of changes within an organization,
Establishment of a clear vision and a change management strategy (timelines, indicators, etc.),
Develop a strong communication material and strategy,
Follow the impact of the changes

Audit Management

Creation of the audit annual plan,
Preparation of the audit,
Conduct of GxP audits,
Redaction of the audit reports and CAPA plan,
Follow the action plan,
Communicate with operational and management,
Management of deviations

CAPA Management

Provide robust deviation management process with efficient deviation identification, assessments and escalation,
Conduct investigations on deviation to identify root causes by standardized methodologies,
Define corrective actions and preventive actions on the basis of conducted investigation preventing reoccurrence of deviations,
Document deviations and CAPA and report to regulatory authorities as needed.

Service Provider Qualification & Oversight

Ensure service provider / vendor qualification,
Assessment of service provider processes and documents,
Establish quality agreement with service provider,
Creation service provider annual qualification program,
Support audit and inspection,
Establish service provider oversight system and quality risk assessment.

Quality Assurance Activities

Risk Management

Based on the referential, Aixial implement Risk Management principles and activities to the life science sector.
Management of Risk activities,
Risks identification and categorization,
Monitoring and review,
Evaluation and treatment (mitigation plan),
Follow the actions and communication.

GAP Analysis

Assessment of performance,
Identification of the gap between the current state and final outcome,
Development of a strategic plan and conduction.

Project Management

Could be based on several approach, in the frame of the continuous improvement (Lean, Six Sigma, AGILE, etc.).
Planification and definition of the project scope and timelines,
Perform the action plan,
Check that the plan was properly conducted, adjust as needed and communicate.

Product Quality Activities

Management of product quality complaints,
Management of Product Quality Review,
Quality monitoring,
Clients and Partners qualification,
Management of Quality Management System,
Contact with Regulatory Authorities.

Aixial Group provides a full range of transversal Quality Assurance services and expertise. From consultant expert to a dedicated platform. We are strong of many decades of experiences, and we accompany our clients and partners on all type of activities. Quality Assurance is a key component for us …

Robin, Senior Business Manager expert in Quality Assurance