Legacy support for in-house manufacturing ERP/process control under GMP

For: Undisclosed pharmaceutical manufacturer

Background: Client was a pharmaceutical manufacturer required by law to follow GMP best practices including validation of all key manufacturing processes. Client had a for custom-built legacy process control platform with integrated ERP functionality that supported manufacturing efforts.

Client request: Legacy process control/ERP platform required functional updates as well as GMP re-validation on update.

Outcome: Accendero Software was contracted to support a fully custom web-based legacy system. Updates and validations were performed on-time and on budget. System modifications underwent government audit and were cleared for regulatory compliance.

Fully custom process control system for operations efficiency

For: Undisclosed pharmaceutical discovery platform company

Background: Client was a pharmaceutical discovery platform company not operating under any formal regulatory regime. Client had a manual process control regime, which was inefficient, error-prone and un-reviewable by management.

Client request: Client enterprise goals necessitated a new process control system to supplant manual process control system to improve operational throughput and minimize waste.

Outcome: Accendero Software was contracted to design and implement a new fully-custom process control system. We delivered this web-based process control software system on-time and on budget. Process efficiency increased more than 500% and allowed organizational transparency. After release, we continued to support the platform as operational needs continued to evolve.

Custom single function ERP solution for patient sample intake under GCLP

For: Undisclosed pharmaceutical discovery company

Background: Client was a pharmaceutical discovery company operating under GCLP. Client had a manual sample intake process, which did not facilitate desired user requirements, such as automated sample barcoding.

Client request: Client requested a validated single function sample intake application. This application needed to support additional user requirements not supported by manual process.

Outcome: Accendero Software was contracted to design and implement a single function patient sample intake application. We delivered this web-based process control software system on-time and near budget. Hidden requirements were discovered during roll-out and the budget was expanded to allow fulfilling them. We successfully validated the system after roll-out.