Conclusion – it doesn’t have to hurt if you chose right!
1st rule of management effectiveness:
“You get what you inspect, not what you expect!”
Being dis-organized is usually the Achilles heel of a smooth-running audit, but being organized can make your life a lot easier. Make sure you know where to find records and documents that are used daily and offload all those that you don’t use. This will make it easier for you as well as for the auditor to get to the fundamental issues of your processes.
So, invest in a Quality Management Software – implement eQMS designed with compliance in mind. It is your best option.
These are essential features eQMS should contain:
- Document control with versioning, history, statue, and e-signatures
- Workflows, Procedures, SOPs, and Processes support – Processes should drive the workflow so users don’t have to, and users cannot ignore.
- QMS progress overview of the various stages and steps in QMS workflow processes
- CAPA tracking system, showing what needed to be fixed, who was assigned to fix it, and what was fixed and support for Risk assessments conformant with ISO 14971
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An eQMS must be dynamic, and capable of being analyzed and changed quickly. A real-time managed system stored and managed electronically provides speed and agility to any organization. It permits management to communicate continually so that the quality message is heard regularly but also delivers procedures, processes, and instructive material to everyone in the organization.
It may seem that a paper-based QMS is cheap to maintain. However, there is a huge amount of hidden costs due to the enormous amount of time the organization spends to ensure the ongoing management of such a system. With an eQMS, you cut down costs in the long run.
An eQMS system when properly implemented of course can be easier to maintain, all the information is immediately available at any workstation, it is easily audited, and any changes are easily communicated across the organization.