QMS/PQS Services for Comprehensive Quality Management.
Quality Management System (QMS): the foundation of all regulated activities in the life science industries.
A robust QMS must adapt with each step of the product lifecycle. In early development, the QMS must be fit for purpose and phase appropriate, reducing unnecessary complexity whilst supporting the compliant capturing of data that will be critical to the future development of the target molecule.
In these early stages, the QMS must also support a company by ensuring compliance with the regulatory requirements, often in circumstances where Quality departments are small, and resources are focused on the development process.
QMS design for Development Phases.
A well designed and fit for purpose QMS provides a framework for ensuring that third parties engaged as part of the development process are capable of providing the required support. It is a key tool for oversight of all third parties ensuring they have the necessary processes and expertise to maximize efficiency, reduce unnecessary cost and reduce the time to market for the Sponsor company.
As the development program progresses to the clinical phases, the QMS must develop and adapt. The QMS defines the Sponsor responsibilities during the clinical phases and ensures that patients are safeguarded in each clinical trial. The clinical operations procedures that form part of the QMS ensure that all diverse stakeholders during this phase are following the same path and again provides a critical framework for compliance with Good Clinical Practice (GCP).
At this stage, the QMS ensures that the Investigational Medicinal Product (IMP) is manufactured according to phase appropriate GMP, under the appropriate licensure and is certified and released to the Sponsor for use in the clinical trial by the Qualified Person. As the program progresses through clinical phases I, II and II, the QMS expands in accordance with the increasing GxP requirements of each phase as the program nears marketing authorization.
QMS for commercialization support.
Once the clinical phase is complete and the product is ready for commercialization, the QMS should be well developed and ready to support the Marketing Authorization Holder (MAH) in demonstrating their knowledge of their product and implementation of their responsibilities for the performance of the product on the market. The QMS supports each license required for manufacture, importation, and distribution of the product and includes instructions for dealing with unforeseen issues such as product recall or return to stock.
The QMS as a business and product blueprint.
As companies change and evolve over the product lifecycle, the QMS becomes the support for the business, providing the history of each decision and provides a roadmap for the company to deal with unexpected events and maintain compliance. With employee attrition, the QMS becomes the constant blueprint for the marketed product and its performance.
Maintaining compliance through simplicity.
As a QMS expands throughout the product lifecycle, it inevitably becomes more complex and often, after a period of time, QMS remediation activities are required to enhance efficiency and reduce complexity of the QMS and to allow evolution of the QMS to meet the ever-changing regulatory requirements in our industry.
Benefits of partnering with Arriello for QMS support:
- Deep industry expertise: Our Quality and Compliance team possess a thorough understanding of GxP regulations and relevant industry practices to maximize the benefit of the QMS to the organization.
- Global reach / local knowledge: We offer QMS support worldwide, ensuring seamless service adapted to your needs.
- Scalable solutions: We adapt our services to meet your specific needs, from single procedure drafting to full phase appropriate QMS development.
Arriello has significant expertise with the design, implementation, remediation management of phase appropriate QMS at every stage of the product lifecycle. Contact us today with your requirements and we would be delighted to support with our team of dedicated Quality professionals.
What our clients say about us.
Throughout the project you have approached the ICON-Arriello relationship with a friendly, constructive and collaborative attitude. I personally appreciated your valuable support, professionalism and conscientiousness. In the face of conflicting priorities and multiple customer demands you remained composed and professional.
Thank you very much to you all involved recently providing the necessary additional audit documents requested by the authorities. Your support was instrumental in successfully finalizing a process that started back in February.
