SyNRG Solutions provides a full range of services for implementing Argus Suite of products. With deep level of Argus Suite expertise, we provide solutions at accelerated pace for new or upgrade Implementations ensuring operational and regulatory requirements are not compromised. With business expertise across Tier I to Tier III Drug, Device and Biotech companies, we provide pharmacovigilance and drug Safety expertise to achieve Case Quality, Reporting Compliance (Expedited and Periodic).
We follow a simple yet effective model for Argus Safety Implementation methodology
As the first phase, it is mandatory to gather and review the user requirements across the board. As different company sites as have business processes, it is critical to make sure that these requirements are not overlooked and not missed hindering compliance. These are achieved with Workshops and Conference Room Pilots (CRP's) set with the Business Users and Managers to determine the optimum way for configuring the Argus Safety Suite.
As the second phase, a Configuration baseline document is prepared which controls the Argus Configuration used during case processing and reporting. With the use of Safety Essentials (Configuration Management) the load and update times are reduced dramatically.
As the third phase, we prepare customized Install Qualification (IQ), Operational Qualification (OQ) and Process/Performance Qualification (PQ) mapping to the Business requirements defined thereby making sure that the Business processes along with the defined configuration meets the company's needs. This phase normally consists of creation, update and execution of the IQ, OQ and PQ. The results are prepared in TraceMatrix document which maps each User requirements to a Unique or set of scripts. At the end a Validation summary is prepared for executive review.
For more information, please contact SyNRG Solutions at info@synrgsolutions.com