Pharmaceutical firms are burdened with more and more regulations to remain in compliance. Today, management teams and compliance departments have an amazing amount of SOPs that they must keep track of and monitor. In fact, for the average firm the training matrix significantly exceeds 100,000 combinations. With such an enormous volume of data, no single individual can keep track of all of it. For that reason, more companies are implementing cloud-based Quality Management Systems with an eye for improving the training matrix.
Over the last few decades, companies have been using excel sheets or crude list applications to monitor their SOP compliance. However, a few problems began to emerge with this method. Firstly, unrelenting regulations by the FDA and guidelines by industry associations have exploded the number of SOPs. At the same time, industry consolidation has led to companies getting bigger. The average pharmaceutical firm is actually 150 people now and the average number of SOPs is 1,250. Multiply those together and you get 187,500 cells in your training matrix.
Excel simply is not made for this many matrix combinations.It becomes slow and unwieldy. Data sometimes does not resolve and computations are slow on all but the most recent versions of the program and on computers with extremely high RAM (usually over 16 GB). In fact, an Excel program with over 100,000 entries can crash the computer that it is running on.
At the same time, an individual simply does not have the power, foresight or management capability to deal with an Excel sheet that large with that many values. It is impossible to locate the individual holes.
For that reason, compliance managers have outsourced the monitoring work to each individual in the company to complete themselves. This leads to two problems. Firstly, some employees simply fail to follow-up and ignore the urging of the compliance manager. Secondly, the employees that do want to comply might not be able to due to the Excel sheet crashing their computer.
Today, companies are finally finding a solution to this problem. They are using cloud-based quality management systems that are run by off-site powerful servers. No matter if the matrix has 100,000 combinations or 1,000,000 combinations, off-site redundant server systems have no trouble handling this computational load.
In addition, the links to these systems are easily shared over email or company-wide communication systems. After an employee completes a course or acknowledges an SOP, they can log-in via an individual account and update the system directly. There is no more management of a large excel file, rather a unified system holds all of the pertinent information.
Lastly, the virtual QMS does all the work of monitoring data and picking out the areas where employees are lacking. Rather than an individual administrator keeping track, the backend system automatically determines which employees have not followed through on their training requirements. Even more important, the system can follow-up directly with an automatic email reminding the employee to complete their training.
For example, salespeople need to know the difference between on-label and off-label marketing of pharmaceutical products. They need to regularly educate themselves on the uses of the products and confirm that they are following all procedures in their day-to-day jobs. The QMS system can follow-up with each individual sales person to make sure they are on target. In case of a management or government inquiry, the compliance team can instantly pull up all of the relevant data on their staff.
Zen QMS is a leading automated QMS provider. It's software solution helps companies virtually implement a high-quality QMS that passes audit inspections and improves the operations of the company. It helps firms save time and money.
If you would like to estimate the costs of your paper or excel training matrix, take a look at our free calculator.