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 a prime area to fail an audit or fall out of compliance. Good Quality Management Systems (QMS) reduce the time
necessary to manage the extensive entries into an Excel or other document based management system. A good QMS 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. Add that amount of data with tracking it all via a paper or Excel management system and you have 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 Quality Management System, training becomes an integral and standard part of operations.
A good QMS will be cloud based and integrated with data management so that department heads have overarching views of training needed and training met. Individual managers will have a smaller view of what is done and what needs to be done. When an employee performs the required training, the QMS will update automatically so that all oversight is updated at the same time. This prevents communication problems as well as reduces human error from updating multiple people regarding the status of training systems.
Document Organization
SOPs are not the only documents pharmaceutical companies must track. Issues, batch records, employee training records, and more documents all make up parts of standard operations. A good QMS manages these documents to reduce the operational clutter and provide universal access to required documents by everyone in the organization. Rather than rush mail orders, faxes and scanned photos emailed to employees in other offices, a cloud based QMS give access to documents to each member of your business and enables swift transference of those same documents to third parties.
Cloud Quality Management Systems enable secure and remote access to a business's documents. This gives Life Science companies the ability to swiftly meet auditors and other governmental and industry oversight needs by giving auditors limited users with access to view all the necessary documents. Additionally, companies can give suppliers similar types of users to facilitate inventory management documents.
SOP Management
SOPs are integral to training and part of a document management system, but have their own unique needs. A good QMS will anticipate and fulfill these needs. This includes training systems on the SOPs, processes to facilitate collaborative reviewing of the SOPs, and universal access no matter where employees are working.
Data Management
Just the SOP data set of an average pharmaceutical company has over 187,500 combinations of training. Add in the data created by HR, customer service, research and development and the average pharmaceutical company will be logging millions of pieces of information in 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 quality management system gives companies the ability to manage and find data. Employees, management, and suppliers engage information in a predictable manner with the right data management system.
A Quality Management System with a strong training component can make the hours of serving an Excel document disappear, giving you and your company more time to improve your compliance profile and focus on the core areas of your organization.
For a quick view of what a paper / excel based Quality Management System really costs, check out our calculator below