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Managing Quality, it's a moving target
If you’re lucky enough to have experienced a pharmacovigilance regulatory inspection, you’ll understand the need to know about, have in place and be able to apply a robust quality management system.
The acronym for a quality management system, ‘QMS’, is being used daily within the pharmacovigilance industry and knowing how to fit this around legislation and operating procedures can be quite daunting.
The Oxford dictionary defines ‘quality’ as ‘the degree of excellence of something’.
If you know pharmacovigilance, then you’ll know about the deluge of documentation associated with this department. The idea of adding another layer to this is something we don’t particularly relish and may even resist.
I was very concerned that improving our QMS to comply with ISO would just add more burdensome volume to our daily processes. I didn’t want to have more documentation, more tracking sheets, more meetings and more reports to administer.
So, it was with trepidation that we started the process to gain ISO accreditation and with that we attended a 2-day training course by the British Standards Institute (BSI) in early December 2014.
What you really have to buy into is the concept of continuous improvement. Quality is a moving target. We know this through the use of CAPA logs and inspection findings, but managing this effectively provides the company with better customer focus and greater control over the direction its headed.
We don’t wait for the money to run out at the bank before we look for new customers. In the same vein, why wait for an audit or inspection to identify system failures? If you can identify deficiencies today wouldn’t you want to? For Red Line, knowing the continued status and level of service to our customers is key to compliance and service excellence.
This course really helped us to gain a better perspective and we were able to see how the implementation of a QMS wouldn’t necessarily hinder us and may even enable us to streamline certain key areas. In addition, we were surprised to see how much we already had in place that we could use to slot into the ISO framework.
With renewed vigour, we’re approaching our gap analysis and following that our two-stage process towards ISO accreditation.
So, watch this space.
Professional enquiry handling to support the safe and effective use of your products.
Ease the regulatory burden and keep compliant with current pharmacovigilance legislation.
Product safety through surveillance of published articles and case reports.
Confident staff to support the pharmacovigilance process.
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