Audit Services and Annual Product Reviews

Whether you're involved in clinical research, trying to bring a new drug or medical device to market, FDA-regulated production, distribution of finished products, supplying materials and services to FDA-regulated companies or buying supplies and services for your life sciences company, a vendor audit program is extremely important for the continued growth of your company.

Periodic internal and external audits reduce overall risks associated with running your business by identifying potential troubles, implementing contingency plans and managing solutions before they become problems.

“If you don’t know where you are, you can’t get to where you need to be… and the best way to measure where you are is an audit by a reputable third party.”

PharmaSys Auditing Experience

PharmaSys has extensive experience auditing GCP quality systems, GMP quality systems, GLP quality systems, computer system suppliers to FDA regulated industries, general processes and facilities, validation readiness reviews and cleaning program reviews.

We have a staff of seasoned professional auditors with an average of over 16 years of field experience in their respective fields. We are available to fly anywhere in the world at a moment's notice.

IT Quality System Audits

PharmaSys has performed numerous third party audits of IT quality systems for medical device manufacturers, pharmaceutical manufacturers and clinical research organizations. Typically self sponsored, the audits leveraged on our extensive experience with current best industry practices to provide feedback to the sponsor organization thereby assuring compliance with current regulations.

"It’s always better for you to find your own problems before the FDA finds them for you."

Software Supplier Quality Audits

Computer supplier audits may be utilized to reduce the cost of compliance by evaluating your software or computer vendor's quality program to identify high risk areas. The audits will expose vendor processes which are less than robust and your system management resources can focus on the problem areas. Conversely, if a vendor process is deemed reliable, you can limit the scope of testing based upon a thorough audit of vendor capabilities.

PharmaSys has performed frequent third party audits of software/systems suppliers in the USA, Europe and Asia for some of the most respected corporations in the life science industry. Audits include clinical data system (CDS) suppliers, remote data entry (RDE) system suppliers, enterprise resources planning system (ERP) suppliers, supply chain execution system (SCES) suppliers, manufacturing execution system (MES) suppliers, and clinical material execution system (CMES) supplier audits.

"A third party compliance audit is sometimes needed to see the organization from the outside. It keeps us honest… honest with ourselves, honest with our customers, and honest with the Agency."

GLP & cGMP Laboratory Audits

PharmaSys has performed cGMP, GLP and validation readiness audits of preclinical and research and development laboratories, as well as of Bioanalytical Laboratories for a variety of customers. Please visit our "Bioavailability and Bioequivalence/ Contract Research Organization Audits" page under the Services menu to learn more.

"I called PharmaSys on Thursday and they had their audit team at our lab the following Monday. They worked through our entire development lab without me having to hold their hands at all."

GCP Audits of CROs, SMOs, Investigators, DM/BioStats Suppliers & Bioanalytical Laboratories

PharmaSys has performed GCP audits of Contract/Clinical Research Organizations, Site Management Organizations, Investigators/Clinics, Data Management Organizations, Biostatistics Organizations and Bioanalytical Laboratories for a variety of customers.

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