Electronic Quality Management Systems (eQMS) have gained increasing popularity within the healthcare industry over the last decade. The following diagram shows the various processes for which management, communication and workflows can be automated via the use of an eQMS
What is an SOP Effective date? It is surprising how often we review a Standard Operating Procedure (SOP) for a client and the SOP effective date is the same date that QA approved the procedure. With the speed of light, the authorised document has travelled from the QA manager’s desk, was immediately processed by the…
eCTD submissions PharmOut dialed in to listen to the eCTD Introductory Meeting on July the 3rd, which was hosted by the TGA in Canberra and was run by John Bell, eCTD Project Manager, TGA and Kent Briggs, Lead Consultant, eCTD Implementation, from LORENZ Life Science. Kent referred to a lot of information already publically available…
The TGA has announced that it has signed an agreement to use the docuBridge® software solution to receive, review and process electronic applications for the entry of prescription medicines and other therapeutic products on to the Australian Register of Therapeutic Goods (ARTG).
Often, companies find themselves inundated with open CAPAs. This is most commonly experienced in the aftermath of an audit, where the CAPA system is used to document the issues that are identified, the investigations, the execution of corrective and/or preventative actions, and finally the closures.
Many pharmaceutical companies struggle to close change controls. Clients often ask if the problem is caused by too many change requests and what is a reasonable number of open changes. The issue for most sites is not the number of change requests, but how old they are. Is there a problem if our site has…
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