Over the years, since before Sarjen developed its first software implemented at a Pharma manufacturing company, we have gained knowledge and built on that foundation to gain the ins and outs of the entire cycle at pharmaceutical manufacturing company. This would involve the business aspect – the development, actual manufacturing, production, marketing, selling, etc. and the regulatory aspect – documentation, audit trails, training, record keeping, audits, etc. for different processes involved.
As very well known to all, Pharmaceutical, Life sciences, CROs, naming a few; face dynamic, rapidly changing business and regulatory requirements. Business competition, market reach, research, investments, etc. pose various challenges. And, the regulatory requirements involve stringent documentation and evidentiary data gathering and compiling it the way required by various regulatory agencies around the world. The requirement can be similar more or less for various different regulatory agencies.
Automating different processes; business or regulatory, help ease the tedious processes. But automating them requires a lot of research to translate the mechanics of the different requirements into software. Not just this, keeping up-to-date with the changing norms is also a herculean task.
And, it is imperative for all to follow business and regulatory mandates and their changed requirements to sustain in the market; although the changes in these mandates are done to relatively ease the different processes in any organization, viz., manufacturing, CROs, etc.
With the background knowledge and research to development, QA and implementation; right from its first software of Advanced Sales management system to its latest software of Pharmaceutical manufacturing execution system and electronic batch records, which comprise various business and regulatory cycles – even integrated with any ERP or other softwares (SAP, SFA, HRMS, QMS, LIMS, DMS, etc.) help cover as many Pharma processes as possible. And, keeping up-to-date with the dynamics of the changing trends, requirements, Sarjen boasts all round expertise of not only development and implementation of its own but implementation and consultation of various other business and regulatory solutions.
Not just the business processes involved in manufacturing, marketing, etc. and their research but also the regulatory requirements, CSV (computer system validation) as per 21 CFR part 11 and Annex 11 guidelines, ISO compliance, where development and implementation need to be as per current regulatory standards.
With an abundance of Subject matter experts and QA at its service, Sarjen can proudly handle analysis of different business and regulatory requirements in the ever changing world of requirements; implement and/or get them developed as softwares, QA, handle client implementation. Sarjen is proud of its “knowledge”, Business and Regulatory, the knowledge Sarjen has accumulated over the years, since before it started development of its first software of Advanced Sales management. Staying on top of any business or regulatory requirement is now a habit with Sarjen which has helped in Sarjen’s growth and outlook.
We, at Sarjen, have evolved over the years, grown as Business and Regulatory consultants to the dynamic world of different requirements.
As business consultants, Sarjen, with in-depth knowledge, clarity on functions and ability to grasp and correlate with actual business processes, offers and has successfully consulted on SharePoint Implementation, interface with SAP, Google drive, Host various business/regulatory solutions on cloud, configure small to mid-sized CRMs, etc. The biggest challenge and learning challenge was to generate various types of reports from enormous data in various databases – using SQL, cubes, crystal reports, etc. gave comprehensive yet multidimensional reports for analyses.
As regulatory consultants,
After successful deploying of these softwares at various organizations, those companies have faced hundreds of successful regulatory and sponsor audits; Sarjen’s softwares have been huge step towards paperless organizations. In doing this, Sarjen has enabled Pharmaceutical, Life sciences companies, CROs… force their attentions to renew their focus and provide with ease in complying with regulatory guidelines and compliance.
Sarjen has been actively involved in helping companies align with complex and disparate regulatory compliance activities, risks into overall corporate strategy.