QUALITY SYSTEMS

A cGMP compliant Pharmaceutical Quality System is critical to demonstrate that you have control over all aspects of your pharmaceutical operation. We have worked with multiple Quality Systems throughout the world and have partnered with the best to be able to offer our clients unbiased support in the assessment, implementation and operation of their PQS.  We provide expertise in:

• Quality System Selection. Our partners specialize in different offerings across Site or Cloud based systems, Development, Clinical or Commercial systems and have multiple add-ons to meet your needs. Depending on your stage of development we can help you specify and select the most appropriate Quality System for your needs. 

• Quality System Implementation. We can assist with the implementation of your quality system along with our Quality System partners and your site based team. We understand the importance of proper implementation and will support you every step of the way. 

• ISO 9001 Implementation. Quality is inherent in everything that we do. ISO 9001 is the backbone of all Pharmaceutical Quality Systems. We see the value of ISO 9001 for both our internal operation and for our pharmaceutical clients. We assist our client build ISO 9001 compliant systems that can undergo the scrutiny of ISO auditors. 

• Quality System Documentation. We assist our valued client build up their internal 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 documents across Quality Assurance, Quality Control, Engineering, Validation and Supply Chain. 

• Project Management. We can provide project management support for your QMS implementation project. Ideally we incorporate ourselves with your site based team and implement efficient project management methods. 

• Client Representation - we often sit in the interface between client sites and Quality System provides to ensure proposed Quality Systemsare in line with industry best practices and regulatory compliance requirements.

• Project Documentation, including: User Requirement Specifications (URS), Plans, Protocols and Reports

• Validation Support, including: Installation Qualification (IQ), Operation Qualification (OQ) protocol generation and execution

 

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.