The pharmaceutical industry is heavily regulated. National and international standards and requirements are becoming increasingly important, if not essential to the conduct of business.
Regulations set up guidelines that manufacturers should follow. They impose an obligation for pharmaceutical companies to develop processes and quality assurance programmes in accordance with the principles. Organisations must enable their stakeholders to work towards continuous improvement and monitor documents and data integrity.
Companies are devoting substantial resources to compliance and process validation. Due to the vast number of regulatory documents and working practices in the pharmaceutical industry, manufacturers need a reliable and effective system to support compliance.
The client is required to train hundreds of employees each year. And due to the often changing legal conditions and the maintenance of a large number of internal procedures, there is a high need for automated process and procedure management in order to stay constantly compliant.
The client had implemented Standard Operating Procedures (SOP), as well as a human resources management system, that eventually made it difficult to synchronize changes in documents, implement them and monitor the effects of these implementations.
The client wanted to automate and streamline internal processes and procedures, as well as reduce human error risks, improve communication in the organization and optimize the costs of handling all processes.
SOPs provide employees with reference to common business practices, processes, procedures, activities or tasks. New employees can use SOPs to answer questions without having to interrupt their supervisors on how a given operation is performed.
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Our solution has been integrated with the client’s SOP system. Thanks to this, it is now possible to coherently manage procedures, their changes and implementation among employees automatically from one platform. Each change in the client’s SOP documents is recorded as an event and based on it the process of changing procedures and implementing these changes among employees is initiated.
As our solution is also integrated with the client’s HR system, it became easy to monitor the status and the number of implemented training courses for employees at any given location.
The client achieved efficiency, quality increase and uniformity of performance while reducing miscommunication and the risk of a failure to comply with industry regulations.
