Change Control Applications | Life Science Software

By: Marci Lynn Crane

At the risk of sounding like a Disney movie, I will tell you a story. Let’s just say that one day I was having a bad day. You’re probably familiar with the scene. Glares, scoffs, and bad attitude were coursing through my veins. It also happened that on this particular day I was headed towards a gathering which I was more or less expected to attend. I didn’t want to go because (as I hope I have duly illustrated) I was feeling like the ice queen of Narnia. However, I did go and a young man who also happened to be attending the event said to me, “You look really pretty today.” It wasn’t much and the words certainly weren’t those belonging to an eloquent descendant of the teenage Romeo, but this young man’s sincerity was as genuine as homemade ice cream. Somehow, in some way, those words changed my day into a time period straight out of a Rogers and Hammerstein musical. Okay….that’s a little far fetched but I did have a much better day and also learned a powerful lesson regarding communication.

Lesson #1
Communication must happen, and it must happen when something is going wrong.

Change Control Application #1
When a change is required in the life science or high-tech industry something is already awry and the last thing a change control manager needs is the actual change control process to go wrong! However, that is exactly what happens in many regulated environments (companies regulated by the FDA, ISO, EMEA (Europe), CLIA, SOX, etc.). Documentation, scheduling, change control related training sessions, and other quality assurance processes can get out of hand fast. For this reason it is essential to create clear paths of communication so that productive communication can happen every time something goes wrong. Clear paths of communication mean more productivity and less change control headaches.

Software Solutions Recommendation
There are a variety of software solutions that are available for change control. MasterControl, a developer of integrated quality management software, provides a MasterControl Documents™ solution as well as a Change Control solution (among many others) that will get you well on your way to clearing up paths for better change control communication.

Scenario #2: Integration is Great
I grew up for the first early years of my life on a farm in Idaho (glamorous I know). It was there that I saw my first “wet back.” He worked with my father on our farm and his name was Manny. I liked Manny because he gave me and my brother candy and made our family tortillas but I knew that for some reason he was different than me and my family. It was years later when I was about to fly to Guatemala to begin a job there that a friend said to me, “You will probably meet a Guatemalan boy and marry him.” I thought the suggestion was ridiculous and heartily denied that would ever happen. After all, the only Latinos I had ever “known” were “wet backs”. However, when I had lived in Guatemala for several months I did meet a boy and began to integrate myself with his group of friends. I learned their language, I danced their dance, I laughed at their jokes and I dated that Guatemalan boy. I had essentially integrated with them instead of remaining separate from them as I had done with Manny. It was then that I learned another lesson regarding communication.

Lesson #2
With integration, communication is pleasant.

Change Control Application #2
A change control manager would readily agree that a change control solution integrated with document control, a CAPA solution, customer complaints forms, training solutions, etc. would be something akin to Nirvana!

Software Solutions Recommendation
Once again, there might be a variety of software providers that integrate solutions, but MasterControl integrates more than a dozen solutions with the foundational software solution MasterControl Documents™. From a customer complaint form, to a CAPA, to change control and then to rewritten documentation and subsequent training, MasterControl can electronically manage your quality and change control processes online from start to finish. MasterControl solutions can also simultaneously help you meet 100% of regulatory compliance standards.

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