What We Are Good At
Implementation is the most important aspect of ERP system & most of the ERP’s fail due to wrong methodology of implementation. Progen has a track record of more than 20 years of implementation experience in the field of Pharmaceuticals. Progen also has the advantage of specialising in pharmaceutical ERP. We follow a practical approach to implementation. We divide the implementation in three phases and allow the system to be absorbed by user at different stages. The implementation can vary from company to company due to different kind of resources. During the process of implementation, Progen evaluates the level of the organisation by change management interviews and accordingly takes care of the implementation. All the phases of implementation would be explained at the time of demo. Implementation method plays an important role in success of an ERP system for pharmaceutical industry. Successful implementation requires a structured methodology. The method should be people and process-focused.
After Implementation we need to check if the implementation has happened to the level expected by the team, for this we recommend the customer to evaluate the level of utilisation of the system done. GAP analysis can also be done after some specific period of time so as to see if the process are being followed and the system continues to give required output or not. By periodically performing a gap analysis, you can look at where your business is headed and whether you have the right tools to get there. Typical issues you may need to address include: Meeting regulatory requirements, streamlining operations to improve productivity and profitability, improving decision-making capabilities, enhancing collaboration with business partners, adapting and scaling business, growing business globally. This helps perform a preliminary gap analysis in each of these areas to help one determine whether there is a need to upgrade their IT solutions and business processes to meet current business requirements as well as adapt to future requirements.
Computer System Validation(CSV):-
Validation is the process of qualifying the ERP software is functioning as per the guideline of WHO GMP and does not allow the deviation so as the quality does not suffer. Once the software is validated, there after managing the system becomes easy. All the deviations must be noted and proper SOP’s followed in terms of running the system. Change control documents need to be written in the event of change of system. Progen qualifies all the validation process as per the requirement of Indian FDA, UKMHRA and USFDA.
Process to be followed while doing Validation:
* Taking decision if the software is cGMP critical
* If yes then Making a MVP (Master Validation Plan)
* Making a core team for Validation
* Doing a complete validation according to GAMP and 21 CFR Part 11
* Doing IQ/OQ/PQ
* Making SOP(Standard Operating Procedure)
Computer System Validation is the technical discipline that Life Science companies use to ensure that each Information Technology application fulfills its intended purpose. Software testing is a key component in this discipline. Systematic Computer System Validation helps prevent software problems from reaching production environments.
Progen has a vast experience behind it to make the organisation suitable for Management consultancy in pharmaceutical companies. Progen has realised the need of proper job profiles and responsibility of each employee as the key essence to success. Progen has been endeavouring to make its customer successful not only in ERP but also in its profits and market credibility.
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