Compliance

Alliance Pharma’s Quality Assurance Unit is an independent entity within our company responsible for ensuring 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 is able to interact with both management and personnel in order to increase mutual understanding and efficacy of day-to-day activities, as well as maintain a clear vision of our common goal. Our size enables an uncommon level of involvement in all stages of project completion, affording flexibility and rapid transitions between different studies in order to meet changing timelines.

Alliance Pharma’s QAU is able to interact with both management and personnel involved in a given project

Qualification

All of our QAU auditors have scientific backgrounds and are able to understand the technical intricacies of the various assays performed at Alliance Pharma. The QAU strives to continuously improve and refine our company operating procedures and record-keeping practices, as well as expand our department’s knowledge of current regulatory topics and trends through outside training opportunities and voluntary independent audits.

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.

SOP and Document Management

The QAU plays a primary role in the development and implementation of Alliance Pharma’s Standard Operating Procedures (SOPs), with a clear goal of making each SOP comprehensive, accurate, and easy to follow. Specific attention is focused on ensuring that SOPs reflect full compliance with all applicable regulations, particularly 21 CFR Part 58: Good Laboratory Practices.