Nutraceuticals Manufacturing Software

ProcessPro^® Premier can provide the tools necessary to comply with FDA regulations.

Records Maintenance

• Links supplier's lot number with internal lot number as well as customer's lot number.
• Tracks carrier/transporter company information in both purchasing/receiving and sales/shipping.
• Able to produce records required by FDA in minutes (FDA allows 24 hours).

Lot Tracking

• Tracks lot numbers for ingredients and manufactured goods.
• Tracks lotted items when stored, ordered, and shipped.
• Automatically quarantines incoming ingredients or outgoing finished goods until passed through QC testing. The user can decide which items.
• Recalls all customers who purchased a finished good lot with the finished goods lot tracking feature.
• Recalls all finished goods lot numbers that used an ingredient lot with the ingredient lot tracking feature.

Audit Trail

• Bill of Material product tracking log provides a robust audit trail for formula creation, modification, deletion, and activation status.
• Complete batch ticket audit logging report of all material transactions with associated user ID, date, and time stamp.
• Audit trail is secure from modification or deletion, and has archiving ability for record keeping.
• Secure, computer generated, time-stamped audit trails record the date and time of operator entry, including creation, modification, or deletion of records.
• Separate privileges for editing of packaged and formula bills of material.

Formula Security
Provides a number of options designed for the multi-location company. These features enhance security within the system so access can be restricted dependent upon the user's access privileges.

Audit Trails

• Audit trail for formula changes in raw material quantities or items.
• Audit trail for batch size changes.
• Audit trail for Quality Control specification changes.

Inactive Formulas

• Any change in a formula will inactivate it so that a batch weigh sheet cannot print until an authorized user activates the formula.
• 4 Levels of User Security
  • Users with no access.
  • Users who can view but not change formulas.
  • Users who can change but not unlock formulas.
  • Users who can unlock a formula.

This document is broken into two parts: the Process Instructions and the Weigh Sheet. It will not print for inactive formulas. An inactive formula is one that has been changed but not approved. It will not print if the formula is out of balance either. Two independent math tests are performed each time a request is made to print a formula.

• Process Instructions
  • Detail manufacturing instructions and testing instructions are included. Simple process instructions can be stored in the ProcessPro^® Premier formula file. More complex instructions are stored in separate MS Word documents. MS Word provides word processing features such as table making, page numbering, etc. ProcessPro^® Premier combines the Word document with the computer calculated weigh sheet.
• Weigh Sheet

• Records formula with ingredient percentages or actual quantities.
• Records intermediate mixtures.
• Records manufacturing instructions, embedded mixture formula.
• Records ingredients in the filling sequence.
• Records multiple packaging combinations.
• Records quality control specifications.
• Records machine steps and labor.

• Supports Weighted Average and Standard Cost inventory valuation methods.
• Tracks unlimited inventory locations and two types of storage divisions within each location.
• Tracks lot numbers for ingredients and finished goods.
• Tracks serial numbers and lot items when stored, ordered, and shipped.
• Allows the user to define units of measure by which you stock, purchase, and sell inventory.
• Allows multiple suppliers for the same inventory item.
• Automatically updates inventory balances with information from Sales Orders, Purchase Orders, and Accounts Receivable.
• Permits inventory items to be set up in price groups.
• Stores average, standard and last receipt cost for each item at each location.
• Allows serial numbers for totes to be located at customer sites in addition to being located in inventory.
• Automatically quarantines incoming ingredients or outgoing finished goods until passed through QC testing. The user can decide which items require inspection.
• Assigns price schedules to specific customer and item combinations, supporting negotiating prices for particular customers.
• Permits the user to categorize inventory items according to their overall performance with the ABC analysis option.
• Allows the user to create multiple price schedules based on markup, discount, or fixed price methods, with options for dollar amounts of percentage. Six quantity breaks per price schedule are allocated.
• Recalls all customers who purchased a finished good lot with the finished goods lot tracking feature.
• Recalls all finished goods lot numbers that used an ingredient lot with the ingredient lot tracking feature.

• Provides tailored instructions for each formula and packaged product.
• Records QC results as products are made or at a later date.
• Provides a warning when/if QC results are out of range.
• Automatically prints a Certificate of Analysis (COA) with the packing slip.
• Tracks test result trends and problem areas.

• Allows the administrator to define test ranges as well as a target value during setup.
• Holds purchased products in quarantine until tested. QC tests are available for both manufacturing and purchased products.
• Allows the user to record test results at any time during or after a batch is produced.
• Records and executes an unlimited number of test instructions.
• Automatically prints QC results for a lot on the customer's COA when the product is being shipped