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Enhancing Microsoft Dynamics AX for Complex Regulatory & Quality Requirements of Life Sciences

Life science companies are facing challenges in response to an increasingly complex regulatory environment. These businesses have to address various requirements that span across geographies, business activities, and processes. Failure to comply with these regulatory practices would be very costly for the company resulting in fines, remediation costs, and reputational damage. To tackle these challenges, AxSource launched AXOQCS TM — a Microsoft Dynamics AX (ERP) based solution meant to enforce compliance and regulatory processes in the life sciences space.

AXOQCS TM was developed by in-house regulatory experts with experience in the industry to ensure practices are met with FDA’s Quality System Regulations, Health Canada Medical Device Regulations, and global good manufacturing practices (GMP) for drug products. The novel solution acts as an add-on to Microsoft Dynamics AX (ERP) to streamline production and quality management through it’s built-in features demonstrated in their webinar; assisting clients like Rapid Self Test Inc. and Body Head Pads Inc. to achieve these standards.

In this webinar hosted by AxSource, Solutions Consultant Evan Pavan, and company president Navtej Sekhon demonstrate how these features allow companies to have good manufacturing practices and meet regulatory requirements. Both Evan and Navtej, provide an overview of AXOQCSTM and its latest functions including: Production Sub-operations, e-Batch Records & e-signatures, CAPA Management, Approved Customer List, and Recall Management.

Production Sub-operations

AXOQCSTM adds sub-operations to standard production operations on the route card. It allows companies to better match their production in their facility to production in their ERP without having extra paperwork to fill in the gaps when standard AX route operations fall short.

DEMO: Evan shows a typical scenario with standard production orders which is then processed through each operation and underneath that each sub-operation that AXOQCSTM creates.

e-Batch Records & e-Signatures

All production data including, Route Operation information, Bill of Materials, any deviations and CAPAs created can all be pushed onto the electronic batch record. It will then be filed and printed when production is finished.

E-signatures functionality extends into multiple areas in the system to sign off on various tasks when a process is completed, such as CAPA reviewed or production operation transactions. Depending on the setup of AXOQCSTM the system can be loose or locked down with e-signatures.

CAPA Management

AXOQCSTM has built CAPA Management functionality from the ground up rather than extending on standard non-conformances in ERP. A separate CAPA list page has been added giving users the ability to process CAPAs in an orderly manner like they would in a typical work item queue. From there users can follow up on future preventative measures and also sign off on CAPAs reviewed.

DEMO: Evan runs into a production deviation in one of the sub-operations, which allows for a CAPA to be created. Then they move through the investigation and implementation of the Corrective action for the CAPA, where they land back in production to finish processing the work order.

Customer Approval Enhancement

Dynamics AX has been extended with customer approval enhancement to restrict sales transactions of products to only approved customers or customer groups. Users can choose who they can sell to and attach an effective and expiration date to define a time when the customer has approved.

DEMO: On a Sales order, Approved products for the given customer can be queried. Non Approved products will warn the user or stop the transaction.

Recall Management

AXOQCSTM creates a brand new list page to process and track recalls so users will be able to find a batch of a product that was sold at a period in time that they define which allows them to track the recall then notify necessary parties with recall letters.

DEMO: After the sales order, Evan will process a recall for the produced and sold batch of product, it will then put the current sales orders that are open on hold and extend recall letters to delivery of these sales orders.

Questions and Answers

In addition to the demonstration, both Evan and Navtej questions regarding AXOQCSTM and its functionalities. Below are some of the questions asked from the webinar:

Q: I’m not seeing a visual indicator of sub-operations that are present in an operation. If I try to complete an operation where there are sub ops present, will it be allowed? Will it be allowed with an info log warning? Or will it not be allowed?

A: Depending on the setup (whether it’s locked down or not), it can either be allowed or not allowed. If it is set so that the main route operations can only be completed when all the sub-operations attached have been passed then it will prevent the main operation.

Q: Is there 21 CFR part 11 compliance validation of AXOQCS itself as well as at the device security level?

A: There is both. For drug manufacturers and medical devices there is validation.

Q: Is this functionality fully integrated into AX 2012 R3 warehouse and transportation management?

A: Right now, we’re currently working on the warehouse management piece to creating work items for AXOQCS tasks. It will be fully integrated in the next version.

Q: For a CAPA evoked in production, can it be taken offline and processed while the production order itself continues processing?

A: Yes, depending on the setup of CAPA. A CAPA triggered to a production order reference can be set up so that it prevents production from continuing until the Corrective action is taken. It can also be set up to not prevent production. The demonstration showed only one user and so production was paused in order to jump over to CAPA to process. Depending on setup a separate user would continue with the production processing and another user would continue with the CAPA processing.

Q: Are there mobile device capabilities for CAPA in the future?

A: Mobile data input will be included in the next Version of AXOQCS which will include CAPA and Production Sub-operations.