With the right software, all formulation, analytical and stability data is captured and managed in a single platform for both small and large molecule drugs. In a common platform used to design formulations, executing processes for batch creation, requesting, searching, reporting, and performing analysis is made simple and overall study-time reduced. Based on best industry practices, crucial decisions can be made quickly and accurately, without compromising on quality.
The IDBS Preclinical Solution provides a foundation for the use of compliant spreadsheets for simple data capture, navigation and a way to search data in a single and secure platform.
Various pre-defined templates enable structured data entry produced during the formulation development process. Configuring templates during analytical method development ensures that the data inputted is recorded in a standardized format to catch any deviations once the methods have been optimized and approved for use.
Our solution enables you to capture batch records and deviations, as well as ensuring existing SOPs are followed throughout the formulation lifecycle.
The E-WorkBook Cloud platform specifically facilitates the design and management of formulations and processes, for the creation of one or more batches, as well as managing formula and formulation compositions. It offers a secure, centralized database for all formulation data.
Configuring and arranging data into a hierarchy not only gives you increased control over the information and permissions, but also enables you to search for specific information with speed and ease.
This is particularly useful for formulations, which involve a complex development process for both small and large molecules. With a powerful search tool, finding key information such as previously used analytical methods, successful formulations for a given API, and to compare and review historical metrics and results is easier than ever.
The combination of first-rate data management and powerful search capabilities provides enhanced visibility of all past data around formulations, their analysis, excipients, PK, toxicity and stability. Increased access to high-value data encourages better informed decision-making.
The complex task flows associated with formulations benefit from a fully searchable detailed audit trail with electronic and digital signatures. Along with streamlining auditing processes, flexibility and control to this degree uphold regulatory compliance and can be used to implement 21 CFR Part 11 processes and are validated in GxP compliant environments as well as protecting the organization’s Intellectual Property (IP).
Regulatory compliance is crucial to reporting, and many formulation groups face challenges in validating their reports to ensure the content is accurate and error-free. Normally, preparing a report can take a few weeks and even longer to validate because everything needs to be checked across different departments against multiple electronic and paper-based systems.
But with the right technology, this process can be significantly reduced while also checking for any errors and inconsistencies. Advanced workflow tools simplify and improve efficiency and communication between team members across multiple geographical locations. Real-time progress information of requests and tasks can be seen by all members of the team.
The IDBS Preclinical Solution offers an elegant system to solve numerous issues faced in formulations by improving access, encouraging communication and facilitating task flow – actively removing bottlenecks and freeing time that would have otherwise been used compiling data for a report.