The goal of every Pharmaceutical and Biotechnology organization is to bring new products to market as quickly as possible, in compliance with global regulations.
R&D / Regulatory Affairs
As soon as a candidate therapy is discovered as having promise, efforts begin to apply for permission to conduct trials. This includes the need to manage all the documentation generated from the research and trials. This need becomes even more acute as clinical trials bear fruit and the organization prepares to file its first NDA or BLA, necessitating a high degree of collaboration between the sponsor, contract research organization, study teams, doctors, and patients. All of these activities generate documents in the thousands in both electronic and paper formats. Having an automated document management and collaboration system to manage research documents, protocols, CRFs, study tagging files, and all other documents related to discovery, makes submissions a relatively easier and more efficient process. Establishing a Quality Management Solution in conjunction with an EDMS for Submission Document Management further enhances the solution by providing a unified platform to also manage study site audits, study deviations, and complaints. Click here to view the QUMAS Solutions for Regulatory Affairs
Manufacturing / Quality Assurance
As soon as a candidate therapy is deemed ready for trials, manufacturing begins and quality assurance becomes an important initiative. By providing excellent Quality Assurance through manufacturing, products can be launched in markets with minimal risk of complaints or recalls. A Quality Management Solution to manage SOPs, Methods, Work Instructions, and Specifications, as well as Deviations, CAPAs, Audits, Change Controls and Complaints ensures that quality standards can be measured, maintained, analysed, and trended for further improvement over time. An integrated Quality Management solution provides Pharmaceutical and Biotech Organizations with the ability to feed information from one process to another such as from CAPA to Change Control thus making it an efficient and effective process and reducing duplication of effort. Batches can be released faster when record keeping is automated thus ensuring that batches do not sit in inventory waiting for paperwork. Also, by providing high quality batches, the manufacturer can operate with the confidence that there will be less batch wastage and rework leading to higher margins and profitability for the organisation. Click here to view the QUMAS Solutions for Quality Assurance
For more information on a Platform approach to the management of compliance across the lifecycle of drug discovery and manufacturing, watch this webinar Regulatory Affairs and Quality Assurance Compliance on a Single Platform