Pharma Supply Chain Software

In compliance with FDA 21 CFR Part 11, our solution can help record any event (new, modified, or deleted record), the user who performed it, the date and time, and the previous and current values of the modified field. 

The solution can generate all types of records in electronic and human-readable format. It is possible to export all the content of the electronic reports into several standard formats (Microsoft Office, PDF, XML). Inquiry forms, reports, and audit trails are available for batch history, quality order results entry, review and validation, creation and approval of products, BOM and routes, production order processing, maintenance order updates, and more. 

Yes, you can trace inventory on hand, even at the sub-batch level (i.e., containers or specific portions of a batch). You can define expiration dates for a single sub-batch and the capability to block them individually in case of quality issues. 

Yes, it is possible to define a fully customizable approval workflow, including multiple reviews, conditional decisions, and approval steps that can vary depending on the type of product and other criteria. Our solution ensures that an item is approved before it is transacted. 

Yes, our solution provides the capability to define a list of approved vendors and manufacturers by item. Based on the setup, the system prevents the creation of purchase orders from a non-approved vendor and/or a non-approved manufacturer. 

You can approve data changes via workflow for key GMP fields in the system. The solution allows an authorized user to approve/reject the modifications applied by another user for second-person checks and approval. For the audit trail, it provides the full history of modification to controlled fields, including the username of the approver, approval date, and time.