FDA Compliance

Adhering to FDA rules and regulations as well as other regulating bodies can be simplified to one word---CONTROL.  AMAPS+PLUS provides a comprehensive set of tools to help you achieve and maintain compliance at the lowest possible cost.

Compliance starts with the Product Definition and Revision.  This process defines what is produced, what it is composed of, the supporting documents, inter-relationships between each of these entities and how the product is produced.

There are many features throughout the Supply Chain Management sub-system that support compliance.  The Lot Management and Traceability (LTS+PLUS) functions of AMAPS+PLUS provide the precise control you need to manage the physical processes of material issue and receipt, pass an audit or, in the worst case, recall a product.

PCS+PLUS the AMAPS+PLUS purchasing system maintains the qualification status of a vendor in general and specifically by the items supplied by that vendor.   A vendor may be in any of three statuses.  A vendor may be unqualified. This status indicates that the vendor has not yet been certified.  A status of qualified indicates that the vendor qualification or requalification process was completed satisfactorily.  A status of unqualified indicates that the vendor may not be used as a supplier.

Qualification solely by vendor assumes that everything supplied by the vendor is either qualified or unqualified.  AMAPS+PLUS adds another, more precise, level of control.  This level enables you to set the status of qualified, unqualified, or disqualified based on the item supplied by the vendor.  Just because an item is causing problems does not, in and of itself, mean that all the items supplied by that vendor are problematic.

PCS+PLUS, furthermore, enables you to identify the preferred vendor and preferred manufacturer.  The preferred vendor is the supplier that you want to use.  The preferred manufacturer indicates that regardless of the vendor this manufacturer should produce this product.

The Customer Order Management System Product Definition Module (OMS+PLUS/PD) also supports compliance.  Sophisticated superseded-by and cross-reference logic ensures that the correct version of the product is ordered by the customer.  The Customer Order Management System Pick Pack and Ship (OMS+PLUS/PPS) works in conjunction with LTS+PLUS to ensure that only lots in an approved status are sent to the customer.

The last of the compliance features include the rigorous enforcement of both data integrity and application security.  The AMAPS+PLUS data integrity features make sure that the data within your system is technically correct.  Application security, on the other hand, prevents unauthorized access to both AMAPS+PLUS in general and specific functions within the system.