Major Pharma Manufacturer Closes Compliance Gap while Improving Business Processes
In the highly regulated industry of pharmaceutical manufacturing, compliance gaps are unacceptable. By implementing CIMINFO’s eInfotree Excel Desktop to manage spreadsheets with security, audit trail and eSignature functionality, this client was able to close compliance gaps in the manufacturing process thus ensuring the accuracy of their drug and product deliverable, and improving business processes.
US Manufacturer of Active Pharmaceutical Ingredients Implements eInfotree Excel Module to Replace Manual Processes
This U.S. based manufacturer of active pharmaceutical ingredients replaced time-consuming and error-prone manual processes with eInfotree Excel Module. This allowed them to control access and track changes to production spreadsheets that calculate complex final release data. CIMINFO also created a trending feature that provided personnel an easy way to monitor and track inconsistencies in the batch processes and report out instantly on those results, using both data compilation and graphing.
Pharmaceutical Manufacturer uses Life Cycle Spreadsheet Management Tools for 21 CFR Part 11 Compliance
The manufacturing of pharmaceuticals is carefully regulated by the FDA and requires an exacting level of precision. Therefore, any spreadsheet errors in a GxP environment, can lead to serious consequences. This client uses CIMINFO’s spreadsheet management software to ensure that a controlled environment is consistent across all users and provides authenticity, integrity and confidentiality of electronic records.
Global Pharma uses eInfotree Excel Desktop for Quality Control
Searching for a more efficient method of spreadsheet management for both quality control and 21 CFR Part 11 compliance, this client conducted a rigorous direct comparison of spreadsheet compliance applications and chose eInfotree Excel Desktop as their solution for all GxP spreadsheets. Significantly reducing new spreadsheet design/remediation, validation effort and timelines while maintaining compliance; increased security, and reporting tools for audit trails, settings and configurations were key criteria in their selection process.
Pharmaceutical Company Reaps Productivity and Compliance Benefits from CIMINFO’s eTraininfo Training Management System
This company with capabilities to provide early phase R&D, pre-clinical, clinical and commercial drug substances from small to large scale production used CIMINFO’s eTraininfo to replace a training system that was a hybrid of paper documents and spreadsheets. eTrainfinfo allowed them to merge those two formats into one easy-to-use and install, electronic training management system that was Part 11 compliant. With the CIMINFO place tracking of training documents, versions, employee training and retraining requirements became far easier and notifications kept employees and stakeholders abreast of changes in requirements.