Companies dealing in Pharmaceutical, medical devices and biotech industries must meet various regulatory and quality requirements of various regulatory agencies and the most important them is FDA and ISO and rest depend on the market where you want to expand.
Getting compliance smoothly is the most challenging task for these all above mentioned industries and effective audit management is the requirement for that.
With the arrival of ISO 9001:2015, you have started to plan to align your audit management practices with updated audit and risk management requirements. You have very limited time to meet these standards before an external compliance auditor literally knocks on your door.
So the demand of an agile audit management software is in the air. In this blog we have tried to find out the pain areas responsible for the automation of audit management practices.
Fragmented set of data
Any Pharmaceutical, Life Science and Healthcare company has multiple departments, multiple processes, and multiple people assigned multiple roles which has been managing manually in most of the companies. Different departments are using their own convenient way of keeping records like SOP, Manuals, data sheets for CAPA applied, OOS and OOT, deviation, change control etc. in Excel, word and PDF formats.
It’s very tough for top level management to view the consolidated picture of audit management practices. An agile audit management software empowers you to centrally manage all your important data required for audit compliance. Top management or external auditor can easily review and provide their valuable suggestions for further improvement.
Poor documentation control
When managed manually then definitely there is always a chance of manipulation/theft/tear of records.
Smart audit management software allows you to keep electronic repository in secure and controlled way. This enhanced security and control mechanism, important for any business operating in a regulatory environment where they are required to demonstrate a reliable tracking and continuous control of important documentation throughout the company’s operation.
Poor flow of communication
Companies operating in regulatory environment need to go through rigorous inter departmental audit practices at frequent intervals. To make advance planning and communicate this to the respective internal audit team members is a cumbersome job for management representative (MR). MR is responsible for ensuring smooth and timely conduct of internal audit, so the chance of miss communication, confusion is very high.
Here the dynamic audit management software reduces your dependability on MR. Just plan your audit schedule and assign team members rest the software will manage like sending auto alerts and notification for keeping the team members on the toe and ensure smooth competation of inter audit practices.
Unable to produce rich graphical insights
Manual audit management practices does not allow you to fetch dynamic graphical representations like increase or decrease in the number of complaints on a prespecified period/drug/region etc.
With Next generation audit management software you can fetch multiple graphical representation as per your demand and put this in front of the management that helps you to strategize further for more advancement.
There are various other reasons that triggers the need to automate your audit management practices but these above mentioned factors are the most influential points.
Are you ready to upgrade?