QUALITY SYSTEMS
PHARMACEUTICAL QUALITY SYSTEMS (PQS)
A cGMP-compliant Pharmaceutical Quality System (PQS) is critical to demonstrate that you have control over all aspects of your pharmaceutical operation. We have worked with multiple pharmaceutical quality systems worldwide and have partnered with the best to provide clients with unbiased support in the assessment, implementation, and operation of their PQS, aligned with pharma compliance standards. This covers expertise in:
Quality System Selection:
Our partners specialise in diverse offerings across site-based or cloud-based pharmaceutical quality systems, covering Development, Clinical, or Commercial operations. Depending on your stage of growth, we help you specify and select the most appropriate pharmaceutical quality management system to meet GMP compliance requirements and ensure your system aligns with Annex 1 guidelines for contamination control and sterile environments.
Quality System Implementation:
We assist with pharmaceutical quality system implementation, working alongside our Quality System partners and your site-based team. Understanding the importance of robust PQS implementation, we ensure your compliance remediation plan is integrated into every step of the rollout, mitigating risks of compliance issues and warning letters.
Quality System Documentation:
We assist our valued client build up their internal quality system documentation, including Policies, Plans, Procedures and Forms to ensure that their Quality System has all the required documentation for compliant operations. We have assisted clients implement best-in-class documentation across Quality Assurance, Quality Control, Engineering, Validation, and Supply Chain.
Project Management:
We provide project management support for Pharmaceutical Quality Systems implementation projects. By embedding ourselves into your team, we ensure efficient project execution and seamless GMP compliance delivery.
We often sit at the interface between client sites and Quality System providers to ensure proposed Quality Systems are in line with industry best practices and regulatory compliance requirements.
Including: User Requirement Specifications (URS), Plans, Protocols, and Reports to support GMP audit readiness, quality system validation, and regulatory compliance for your pharmaceutical quality management system.
Validation Support
Including: Installation Qualification (IQ), Operational Qualification (OQ) protocol generation and execution to guarantee validation of your Pharmaceutical Quality System (PQS).
We work in collaboration with your onsite team and our Quality System partners to support your PQS implementation project. Quality, compliance and project delivery are at the core of what we do. Get in contact today to see how we can assist with your pharmaceutical quality management system and compliance needs.
