GxP Audit Program Management
Outsource your supplier qualification audit program to PCS. We take care of the initial contact, planning, execution and reporting stages. Care-free supplier qualification.
Over 550 audits performed worldwide!
We can take care of your entire audit program. By outsourcing your audits to PCS you save time on; communication, planning, execution and reporting. This can save you up to 40 hours of work per audit. That’s an entire workweek!
Clients ask us to qualify suppliers and contractors in the pharmaceutical industry and biotech industry. Our auditing services are worldwide and cover every major regulatory framework.
Curious to see how we can help you with your supplier audits? Plan a meeting today!
Worldwide audit program management for Novartis
PCS performed the supplier qualification program for Novartis. This amounted to over 100 audits per year against the GxP's.
Audits of antivenom suppliers for the Dutch Ministry of Health
PCS performed a number of audits against the EU GMP at suppliers of antivenom and vaccines for the Dutch Ministry of Health.
PCS performs the initial contact with the auditee. This includes; notification of the audit, communicating previous audit reports or regulatory audit reports, discussing audit requirements and the best way to travel to/from the site.
The initial communication is initiated circa 2 months before the audit is set to start.
In the planning phase we discuss the best dates with the auditee. This process can take some time; production schedules, routine maintenance and absense of staff are complicating factors.
PCS finds the most optimal date with the auditee and requests your approval. We align on the audit agenda, schedule and travel plans.
The execution phase consists of the on-site audit, including traveling to the auditee. Qualification of suppliers could take up to two days per auditee, depending on the criticality and type of product.
We travel to the site, we perform the audit and start our reporting. In most cases you will get a close-out letter, sent to you on the last day of the audit. This letter contains a general impression of the auditee’s compliance status.
We use a standardized reporting tool in our software; PCS Intelligence. This reporting tool generates a standardized format containing all the necessary data that surrounds the audit. The observations are linked to the paragraphs in the regulatory requirements.
This allows us to report quickly and accurately, preventing any debate with auditees on the validity of observations in relation to the GxP’s as they are directly linked to the regulations themselves.
Let me help you explore all the benefits of our services!
PCS prepares, performs and reports the audit directly to the client. The focus of the audit is determined by the client and can include (for example); due-diligence, for-cause, following a complaint, routine, self-inspection, etc. If desirable, PCS can recommend and review CAPA’s following an audit.
Audit services;
If you are interested in training your employees in the GMP's or GDP's, have a look at our seminars, in-house training and eLearning.
Outsource your audit to PCS, we usually respond within the hour!
We have the expertise and experience to perform your GxP audits worldwide!
