Alliance Pharma’s Quality Assurance Unit (QAU) is an independent entity within our company responsible for assuring that every project produces data of the highest caliber. Through direct study audits, internal system audits, and external vendor audits, the QAU is aware and involved in every facet of project development, execution, and data retention. Alliance Pharma’s QAU interacts with both management and lab personnel to increase mutual understanding of day-to-day activities, and to maintain a clear vision of our common goal. Our size enables an uncommon level of QAU involvement in all stages of every project, affording flexibility and agility, which allows us to meet challenging and evolving timelines for our clients and partners.
Our size enables an uncommon level of QAU involvement in all stages of every project, affording flexibility and agility, which allows us to meet challenging and evolving timelines for our clients and partners.
Our team consists of seasoned QA auditors with extensive experience supporting regulated studies and submissions to regulatory agencies in various countries around the world. All of our QAU auditors have scientific backgrounds and are able to understand the technical intricacies of assays performed at Alliance. The QAU strives to continuously improve and refine our company Quality System, including audit procedures, record-keeping practices, and personnel training.
The QAU participates in all client, independent and regulatory agency audits in order to obtain the best possible understanding of ways to meet and exceed our client’s expectations.
Regulatory Inspection History and Accreditations
Since inception in 2008, Alliance has hosted two successful inspections by regulatory agencies:
- 2015: Environmental Protection Agency (EPA) (no findings reported)
- 2019: Food and Drug Administration (FDA) (no 483s or observations)
In addition to our unblemished regulatory inspection history, Alliance has maintained continuous accreditations with various agencies in support of our service offerings. We are CLIA and COLA accredited and have maintained accreditations with AAALAC® and OLAW since the establishment of our in-house vivarium.
SOP and Document Management
The QAU plays a primary role in the development and implementation of Alliance Pharma’s Quality System and assures each Standard Operating Procedure (SOP) is comprehensive, accurate, and easy to followwhile meetingfull compliance with all applicable regulations, particularly 21 CFR Part 58: Good Laboratory Practicefor Nonclinical Laboratory Studiesand 21 CFR Part 11: Electronic Records and Electronic Signatures.