Pharmaceutical industry would revolve round the discovery, development, and manufacture of drugs and medications and other pharmaceuticals by organisations.
In the entire process of manufacturing to sales to market, several sensitive aspects are involved. Which would in turn require processing, storing, and retrieving of different data from different sources.
With digital transformation in the industry, Sarjen plays an important role in enabling organisations bring in efficiency and digitalization and automation to the most fullest.
Electronic batch records software application which automates the processes at manufacturing industries from raw material through manufacturing to packaging. Is essentially electronic capture of data in various operations of manufacturing industry.
The entire supply chain and sales & distribution network and operations; integrated with ERPs such as SAP. Also, helps in primary, secondary, and tertiary sales channels with consolidated picture and analysis.
Automated salesforce system – the calls, activities, targets/achieved, plans along with electronic detailing with visual aids, geo tagging and more. The Fforce bundle also concentrates on distribution management, patient relationship management, FSIS (sales information). In short, the 3600 sales force automation and excellence.
Maintaining enterprise-wide quality in all aspects is much essential. Especially QC and QA departments with their predefined operational norms play an important role in this managing enterprise-wide quality. Quality processes such as Change Control, Market Complaint, Deviation, Investigation, Risk Assessment, OOS, OOT, etc. can be digitised for much efficient functioning.
Along with, Document control – controlled and uncontrolled copy – authoring, review, publish, distribution (for SOPs, Specifications, Work Instructions, any other documents).
Also, along with eLearning and Training with ready availability of training material, Employee dossier with their training details and much more…
When organisations are ready with marketing the drugs, there is sequential, detailed process to get approvals for selling drugs in different countries, different markets. Each with its own requirements; require several documentation in specific order-format and “submit” to respective regulatory body – get approval – market drugs.
When the drug is in the market and any side effect – adverse events (mild to severe to death) would be captured and the information processed as mandate and, also, submitted to the regulatory body, may decide the fate of that drug. Pharmacovigilance and Medical enquiry for adverse events and submission of such information is defined as drug safety.
Electronic signatures of CSV documents, workflow driven signature captures, other documents with/without workflow – track the signature process – even store and archive documents (older and current) for convenience, audit readiness.