Osmotica Pharmaceutical - Case Studies​

Donna Lenning ​

Osmotica Pharmaceutical

What challenges / business issues were you experiencing that made you consider a new ERP platform?

We were either executing all business processes manually or with simple automation such as QuickBooks for financial processes. In order to prepare for the planned growth, our leadership decided to begin the implementation of Microsoft Dynamics AX in 2012 in order to have a fully automated process experience in the organization.

What value did Merit Solutions provide during systems validation?

Merit Solutions facilitated the User Requirements gathering process, assisted with documenting those requirements as well as the functional configuration and design documentation. They reviewed the Operational Qualification protocols and then provided valuable on-site assistance during the execution of the Operational Qualification protocols as the functional and technical resources to resolve all discrepancies during the execution. They also reviewed the installation qualification and provided remote support during the execution of the IQ. Lastly, they assisted with end user training and production cutover activities as we worked through the transition from manual processes to automated processes.

What other benefits have you realized since implementing MAXLife with Dynamics AX?

We now have lifecycle management of our raw materials release process from planning to purchasing to receiving to testing and finally to release. Also, MAXLife was critical in ensuring that the Dynamics AX GXP functions were implemented with the appropriate 21 CFR Part 11 compliance requirements such as electronic records with electronics signatures and audit trail.

How has Merit Solutions’ knowledge of the pharmaceutical industry helped you?

Merit Solutions immediately understood the rigorous and complex requirements of the pharmaceutical industry as a regulated industry. With specific knowledge of process manufacturing as well as lab functions that are supported with inventory management and finance functions, Merit Solutions exhibited a full life cycle breadth of knowledge and experience. It was especially important for us, because being a company with manual processes, we were able to leverage Merit Solutions best practices experience. Additionally, because of limited in-house resources, Merit also was critical for staff augmentation as we implemented AX with MAXLife extensions.

What do you like about working with Merit Solutions? Would you recommend Merit Solutions to other Life Sciences companies?

Though Merit’s life sciences experience was invaluable, the thing I like best is the integrity and resourcefulness of their consulting and development staff. They don’t just get the job done, they get it done on time and provide quality deliverables which is critical to ensure efficiency, effectiveness, and compliance. They don’t give up and they always make things right. I trust them implicitly and I look forward to our continuing relationship.

How has Merit Solutions improved your day-to-day operations?

We have automated many critical processes from document management to inventory management to lab life cycle management using MAXLife. Our employees are using the systems and have seen efficiency improvements as well as a confidence that we are producing compliant GxP deliverables. Our users are looking for more out of the systems now… Merit has helped us leverage the system even though all processes aren’t yet automated. We still have manufacturing, EAM, and quality systems left to implement as we move toward our technology strategy of a fully integrated Life Sciences ERP solution using Microsoft Dynamics AX as the foundation. Merit is an integral partner to our vision and I look forward to our continuing partnership.