SAP

If one closely examine the working model of the Pharma companies than at the core of it are the Standard Operating Procedures which are a result of inputs from validated and compliant processes framework (GxP’s, GCP, GLP, cGMP, FDA guidelines 21 CFR Part 11etc) which Pharma companies have to follow to stay compliant with the regulatory authorities. Will it be safe if these are Offshored? The Pharma processes themselves are complex be it Manufacturing, Inventory, Sales etc wherein the underlying IT applications and systems are validated systems and electronics records of each access, process steps and associated documentations are to be maintained. Would we lose control over these processes? Would my data and information be safe? Is there a proven case? These are the typical questions which Pharma companies tries to find an answer for and such questions and apprehensions are to be addressed to significantly boost the Pharma IT Offshoring.

Security of Data, Validation and Compliance adherence is what Pharma companies will like to achieve from their Offshoring venture. Not all IT Service provider may have knowledge in these aspects. Also, the operational processes and tools may differ from one Pharma companies to another. Thus, to be successful the Pharma IT companies should first build a Offshoring model with robust process framework which has a same Validation and Compliance level as if work is being executed from Pharma Companies own offices. For this, in arrangement with IT service provider, trained and certified Pharma Quality Managers should be put in place for each of the IT Projects and Support engagement. Implement the Security and Authorization policies with relevant access. A better arrangement is to have the dedicated floor space with monitored and restricted entry/exit access to project personnel only. Such an arrangement mimics as if work is being done from an onsite location and has the same quality and process adherence. Each work package executed from offshore should be checked and audited by the Pharma Quality Managers in place for these tasks. This would also further raise the confidence level that Offshore work meets the required adherence. Perform quarterly audits over the process compliance from Offshore and plug the gaps. The Offshore Pharma Quality Managers should form the extended team of the central Validation and Compliance department of the Pharma company. Monitor the Non-conformance and process violations from Offshore and include these in the Offshoring KPIs. Once this is sustained for six months to a year than in subsequent phases IT Offshoring volume can be increased to realize the full potential.

Presently, the Pharma companies doing IT offshoring successfully are the ones which have entered into long term relationship with the IT Service providers as both the parties have to incur the intial investment to build and operate the sustainable model. There are successful examples of Offshoring of critical enterprise applications e.g. SAP support and maintenance engagements and SAP Implementation and Upgrade projects to name a few.