According to the Journal of Pharmacy, the average pharmaceutical company has 1250 Standard Operating Procedures (SOPs) and over 150 employees. This makes a typical Excel training matrix responsible for at least 187,500 combinations of training (1250 x 150). These combinations do not account for tracking revisions of SOPs, managing relationships between different offices, or integrating research and development with SOP updates.
Maintaining a non-validated training matrix at even a fraction of that size is one way to fail an audit or fall out of compliance. Compared to Excel or another document-based management system, a good electronic Quality Management System (eQMS) will reduce the time necessary to manage these extensive entries. Additionally, a good eQMS will meet a life science company's needs in the following ways: training management, document organization, SOP integration, and data management.
Training Management
Keeping track of 1250 SOPs is difficult. Keeping track of employees' understanding of 1250 SOPs is more difficult. That amount of data tracked with paper or an Excel management system means hundreds of hours of management processes. Training is essential to quality, but it does not have to break the bottom line. With proper training management in your eQMS, training becomes an integral and standard part of operations.
A good eQMS will be cloud-based, and integrated with data management so that department heads have visibility over training. When an employee completes their training, the eQMS will update the status automatically, significantly reducing communication problems and human error.
Document Organization
SOPs are not the only documents pharmaceutical companies must track. Issues, batch records, employee training records, and other documents all make up parts of standard operations. A good eQMS manages documents to reduce operational clutter and provides appropriate access to approved parties.
Cloud-based electronic quality management systems enable secure and remote access to a business's documents. This gives Life Science companies the ability to swiftly meet regulator's needs by giving their auditors limited access to their requested documents. Additionally, companies can give suppliers similar permission and access to documents to facilitate inventory management.
SOP Management
SOPs are integral to training and are part of a document management system, but they have their own unique needs. A good eQMS will anticipate and fulfill these needs. They include training systems on the SOPs, processes to facilitate collaborative reviewing of the SOPs, and universal access no matter where employees are working.
Data Management
A SOP data set of an average pharmaceutical company has over 187,500 combinations of training. Add in the data created by HR, customer service, and research and development, and that number balloons to millions of pieces of information a year. While most of this data would be lost or require extensive amounts of labor to find in older management systems, a cloud-based eQMS gives companies the ability to manage and find data easily. Employees, management, and suppliers engage information in a predictable manner with the right data management system.
An eQMS with a strong training component can make those hours formerly spent in Excel disappear, giving you and your company more time to improve your compliance profile and focus on the core areas of your organization.