When conducting an audit, the auditor should first assess the company documentation against the related reference documents. Any findings would then be against company documentation or the quality management system. Then the auditor should match employee actions and records (performance) against what is stated in their own internal documentation. Any findings noted would be against performance of actions as required.
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Entries by Regula Inspection Services
Companies that do not have much knowledge about how the FDA conducts inspections or are not ready for an audit always have difficulty. FDA inspections, announced ahead of time or not provide great opportunities to carefully examine the GMP compliance of pharmaceutical, biotechnology and medical device companies.
One part of an internal auditor’s life is the eventual (in some cases constant) contact with an auditee who plays some type of game. The reasons for auditee games are varied, but mostly they occur because the auditee believes (or knows) that the audit will not go well. Despite what we say, and do, most […]
Time Management Time is beyond all doubt the GXP Auditor’s worst enemy! Many GXP Auditors find themselves running behind the Audit schedule on just about every audit. GXP Audits are often not a thorough as they should be, which tends to diminish their effectiveness. So, how do we manage this thing called time? The first […]
Almost entire Asia and Africa and major part of Latin America are out of the up to date PIC/S Guidelines and Aide Memoirs? https://www.picscheme.org/en/members
Regula Inspection Services would like to share its comprehensive experience with you by providing expertise trainings for GXP Auditors. We are delivering several special expertise trainings such as; Packaging and Labeling for GXP Auditors (2 Days) Analytical Method Validation for GXP Auditors (2 Days) Biotechnology for GXP Auditors ( Upstream-Harvest-Downstream) (4 Days) Data Integrity for GXP Auditors (2 […]
REGULA INSPECTION SERVICES INTERVIEW Regula Inspection Services is a young company that aims to provide high quality, technically reliable and high value added inspection services especially for Pharmaceutical, Biotechnology, Medical Device Manufacturers and Suppliers. Deniz Edik is one of the founders of the company and has a reasonable background in Pharmaceuticals. She is an expert […]