Pharmaceutical Industry
Pharmaceutical Industry
Clear Software Pharma Manufacturing ERP is designed for pharmaceutical companies subject to cGMP guidelines as described in cGMP FUNCTIONALITY section 21 CFR Part 211.
Clear Software Pharma Manufacturing ERP includes a quality status for each inventory record as well as other features to satisfy current Good Manufacturing Practice (cGMP) requirements. In addition to the functionality found in the standard version of Clear Software Pharma Manufacturing, the list below indicates some of the unique features included in the Clear Software ERP.
Feature & Benefits
- Inventory record includes release status, retest date, and expiration date. Inventory records must be changed to release status prior to use in production (i.e. material issue).
- Batch Tracking Log includes batch record review dates, QC dates, corrections, dispositions and other information associated with a batch record. Retest/expiration dates are calculated automatically based on offset period maintained in the Item Master. Batches with upcoming retest/expiration dates are identified by generating the Retest/Expiration Date Report.
- Vendor item records include vendor NDC number and audit rating for each vendor part number. Customer item records include customer NDC number for each customer part number.
- Drug License registration number and expiration date for company, customer, and vendor records. The setting for the DL registration requirement is set at the item level and checked when adding customer orders and purchase orders.
- Numerous inventory and batch record reports available to summarize batch record activity and review batch status.
- Audit trail history is maintained for changes to customers, vendors, items, product configurations, customer orders, shop orders, purchase orders, batch tracking log, and all inventory transactions.
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