Pharmaceutical Manufacturing Software

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.
• Option for Electronic Signature tracking.

Locked Formulas

• Any change in a formula will lock it so that a batch sheet cannot print until an authorized user unlocks the formula.

5 Levels of User Security

• Provides a number of options designed for multi-location companies. These features enhance security within the system so access can be restricted according to the user's access privileges.
• Facility Level. User from facility X cannot access formulas that belong to facility Y.
• 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.
• Force user password changes.
• Password expiration.

Let the advanced functionality of ProcessPro^® Premier help you meet 21 CFR Part 11 requirements. The features of ProcessPro^® Premier provide security, audit trail and electronic signature options to help organizations comply with 21 CFR Part 11 Electronic Records and Electronic Signatures Final Rule.

Levels of User Security

Security

• Maintain security regulations at login with a required combined code for user ID and password.
• Privileges allow the system administrator flexibility to assign access levels to multiple user groups or individuals.
• Password maintenance allows control over user access by function, time of day and date range.
• Encrypt user ID and password for added security.
• User can view records without the authority to edit.

Electronic Signature

• User name appears on screen to reduce inadvertent entries.
• Reasons listed when user is prompted for signature to ensure if user is signing for the appropriate task.
• Option for required user login and password at subsequent sessions of processing, including security checks to authenticate user ID, password, and privilege for desired use.
• Option for signature manifest to capture and electronically save user's actual signature.

Audit Trail

• Bill of Material product tracking log provides a robust audit trail for formula creation, modification, deletion, and activations status.
• Complete work order 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.

Click to access the Roadmap to Validation

FDA Scheduled Drug Check and Reporting

• When a sale of a scheduled drug is made, the system will check the customer's FDA number and expiration date before the sale is allowed. Legitimate sales are tracked for future reporting.

Medicaid Reporting

• Liquid sales are reportable in milliliters even though sales are made in containers with varying standard or metric sizes. Tablet and capsule sales are reportable in grams although sales are made in bottles of varying quantities.

Lot Tracking Report

• Any lot number sold can be later recalled to show all customers who purchased the lot and all the ingredient lot numbers that went into the finished product.

For sales made through drug wholesalers

Bid Group Contracts

• A contract records items, prices, customers and expiration dates. One customer can be on multiple contracts. If sold to directly, customers receive the best price for the contract of which they are members. If the wholesaler sells to a member of a bid group the company is associated with, the sale will be connected to that company contract via a chargeback.

Chargebacks

• When a wholesaler of the product sells to customers in bid groups under your contract, a chargeback needs to go to the wholesaler. The system will allow speedy chargeback entry and validation. A chargeback will be produced and the detail is stored for bid group reporting.

Bid Group Reporting

• A sales report is available for a bid group for any date range. One or all customers can be selected. This report includes both direct sales and sales made through wholesalers that requested chargebacks.