Mandatory Regulatory requirements to control the documents in life Science organizations recognize the need to have easy to use Document Management Solutions. Pharmaceutical and Biotech companies are challenged to meet control documentation requirements in the day to day operations. Effective document control management and document control are critical parts of any quality and compliance solution. For many employees, the requirement to access their DMS is a daily requirement, and they need to have fast, easy access to an intuitive system that meets 21 CFR Part 11, GAMP5 requirements. Global Regulatory agencies expect that all regulated companies follow current industry best practices throughout the manufacturing process.
In the Quality Assurance sphere, users need a solution that allows for well built version control and audited distribution of SOP’s, STP’s and other regulated documents, to ensure that only the latest versions are in circulation and users are adequately trained on the correct procedures. These documents may require printing in which case strict print controls become an essential feature as well.
To meet these requirements, Fransha Pharma LLP has developed docuDrive software (Document Management System software) which helps to control and distribute the SOP’s, STPs and other regulated documents. docuDrive software system not only reduces the cost of compliance but also helps you improve the process and product quality. docuDrive Software can retrieve the information you need exactly when you need it and minimizes the possibility of miscommunication and mistakes which in turn reduces risks, working hours and other documentation expenses. In other words, having the right documentation available at the right time will save the organization’s time and money.
docuDrive is a web-based solution to manage the document life cycle and document approval cycle securely. It effectively controls the documents and their approvals in a single repository with any number of users as per the permissions defined.
The solution provides a safe and secured centralized environment to access the document with its abundant source and version control mechanism. docuDrive can also be interfaced with our eCTD management system, Training management system, and Quality management system making it a complete package under one roof.