“Fickle-natured with copious details”

Time and again we commit ourselves to stay on top of required regulations for our specific business. But do we really? Yes, we keep everything organized electronically but how effective is this way of ‘record keeping?’ The appropriate and evolving mechanism to run a full compliance life cycle is often lacking in many organizations and hence, we fail to execute processes (PSM) that were meant to protect us from failing in the first place.

A recent survey where organizations were asked if and how they have implemented a regulatory change management software solution

The results simply complements recent conversations I had with various clients on finding the simplest ways to automate different functions while managing compliance. “Fifty-three percent (58%) of us simply manage the date in spreadsheets, documents and emails – and the biggest pain is to integrate all of the data and create a usable result out of it.” A tool that lets you collaborate with personnel and integrates the data on its own. For example, your focus is to be on one CFR at one time, reading and getting the real/simple meaning out of it and implementing it through one platform.

In another scenario, the customer was concerned about not having CMS (control management solution). How do you control your lively assets (in this case, human capital)? By controlling it means tracking compliance for a work site that has over 150 workers, and to add to the beauty of it many in diverse, classified roles. One needs to ensure proper controls in place to ensure multi-million dollar projects don’t go south because of the lack or absence of controls. Controls are built on concrete workflows allowing you to manage your assets (human capital) and their performance effectively which all starts from bring on the upside of compliance.

If you already have a solution in place, here are some key functionalities you need to ensure:

• Does it give you the business intelligence to see what’s really happening in your facilities/plants?
• How stress-free is it to take action from your system? The real purpose is to hold people accountable for actions and tasks. Does it show a trail of data leading to a certain event or what CAPAs were executed to avoid further incidents?
• Does it break down regulations into meaningful tasks? Transaction and applicability.
• Does your solution update you of any changes in regulations that apply to your organization?

PREDICT360 REGULATORY CHANGE AUTOMATION

Predict360 contains modules that run the entire compliance cycle, allowing you to perform CAPA and ensuring you are able to do tasking and tracking of daily operations, project management, quality management, incident management, task management and legal case management through customizable and configurable workflow into electronic forms that are accessible through PC and all mobile devices.

Combining software solutions and expert consulting services, I’d like to share with you our recent webinar on the 14 Elements of PSM and their real world applications. Click here to view a recording of the webinar: My Organization is PSM-Covered: Now What?

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