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How To Avoid A Change Control Breakdown
By Adam Huang Published: 01/28/2010
There are many industries that require businesses to meticulously track and record their change control processes, which is why many of those businesses are turning to change control software to help them streamline their procedures and avoid the breakdowns that can damage the company's returns. If you have the right software integrated in your system, though, those breakdowns don't have to happen to you.
Change control relies on communication. Unfortunately, not all companies communicate all that well. For example, if a company decides to use a paper-based system, they may be able to save some money at first, but without using change management software they will end up forcing employees to spend much more time doing the work.
Manual solutions require a lot of time to run around looking for the right people and materials to complete the creation, routing, and approval processes. This creates a situation where outdated SOPs never disappear and a lot of people end up confused about which document versions are the most recent. There is also a lot of frustration because there isn't enough accountability among employees. This company is likely headed toward a breakdown in communication.
Consider another company that uses change control software. They can control the entire process online and still meet all the FDA, ISO, EMEA, Sarbanes-Oxley compliance regulations. All of this company's change control procedures will be connected so that their CAPA, audit, training, and customer complaints applications will work seamlessly together. This is how companies can automatically take care of their creation, routing, and approval processes.
The training procedures associated with change control documentation and regulation make a difference in every department from research to production. If a company decided to use a paper based system it would take hours of legwork and manual routing and approvals before the change control process is finished and their documentation is delivered to someone who can implement it.
Once the people that need the training documentation receive the new procedures, they might still fail to locate or dispose of the old SOPs. This means that many people can remain uniformed about the necessity of the new training or whether or not there will be an exam required at the end of it.
Another company chooses change control software. Then their will their final SOPs will be automatically routed and approved by the people specified while setting-up the software. Applicable personnel will also be aware of any outdated documents and updated regarding whether or not training is necessary. They will be apprised when and where training will occur, and then given electronic quizzes or exams if required.
As companies require help to track and manage their change procedures in a highly regulated industry, change control software can help a lot. Start searching for an effective program and start implementing the procedures you can rely on. - 28385
