A multinational pharmaceutical company manufactures and markets pharmaceutical products, and intermediates globally. Being a pharma manufacturer the regulatory and compliance requirements are very stringent and apply to almost every aspect of their day to day operations. The regulatory and compliance requirements mandate documentation and audit of all production operations. The documentation is generated at various points in multiple systems. It was a challenge to collate all these documents and maintain them in a timely and structured manner. Workers, auditors and managers need to manually add these documents to a document management system. Machines used in production also generate a significant amount of
data which has to be recorded and maintained for each batch of production. This was recorded manually and then pushed to the document management system. This process being a manual and intermittent one was effort intensive and error prone.
The CIO of the organization was on a mission to reduce the errors encountered in auditing, recording and documenting the events. As most of the errors were introduced due to manual intervention, automation was an obvious solution. However systems involved being discrete and disconnected automation was a huge challenge. The CIO engaged Zogato for envisioning, designing and implementing a possible solution for this challenge.
Zogato analyzed the points where documentation was generated and the systems that generated the documents. Zogato also deeply analyzed the existing document management system on how documents are added to the system. Zogato then presented a solution to the CIO on connecting the disparate systems, which after deliberation, review of technical challenges and due diligence was approved by the CIO and her team. The main objective was to develop connectors to all the involved systems and orchestrate the document generation and storage activities.
The involved systems worked on multiple technology stacks and stored data in a non-standard format. Hence connectors were to be built such that they could work on those tech stacks and at the same time communicate using a common protocol to exchange information in a format understood by other systems.
Some of the involved systems enabled extensions by writing additional APIs over them to exchange information while some others did not allow the same. In the latter case Zogato had to go down to the database level. Understand the structure in which data is stored in the DB and then build additional components to retrieve data directly from the DB.
In case of integration with production machines the information was available as raw text rather than documents. Connectors to these machines had to retrieve the data as raw text, generate a PDF document from it and then push it to the document management system.
Some system extensions in the form of Restful APIs and DB triggers enabled push of new data from the source systems. However data had to be pulled from certain others which did not allow pull. Zogato created independent components which would pull data at set intervals using schedulers and push it to the document management system. In case of production machines Zogato had to use SCADA and some IoT protocols to communicate and retrieve information from them.
Zogato enabled timely collation and structured storage of operational records and audit documents to a single document management system. This document management system was connected to the main reporting system of the organization. This enabled the management to ensure all record and audit related documents are in place and regulatory compliance requirements are met.
The solution greatly improved
The solution enabled communication between disparate systems thus increasing the life span of the systems and reducing technical debt.