Need for PV Safety Solutions
The stringent compliance requirements imposed by regulatory agencies compel pharma companies to opt for one of the many PV Safety solutions available in the market. Traditionally, bigger companies have on-prem implementations in one of their data centres and smaller companies opt for the shared services of a CRO. Recent trends indicate companies also opting for a SaaS product or a dedicated AWS hosted solution.
Post-implementation business support – the real challenge.
However, the pharma companies have come to realize that PV Compliance is a bigger battle that is not even half won with a Safety System implementation and that this is only the first step. The real challenge lies in the post-implementation business support, wherein the end-users of these Safety Solutions have to depend on the limited domain knowledge of the faceless support team member sitting on the other side of the line, to help meet their day-to-day compliance needs. What follows is the endless transactions of emails and calls with the end user trying to explain his/her needs, and the support “engineer” on the other end trying to translate it to technical specifications.
The primary reason behind this gap lies in the business focus of the product companies and the CROs. The product companies are focused on providing product related technical support while the business focus of the CROs is to support their customers in the clinical trials or research thus having support teams built around the same. Both these groups, hence require a layer of techno-functional experts that can form the bridge between the product companies or the hosting service provider or the CROs and the end user. This layer of techno-functional experts brings with them a combination of PV domain knowledge and the technical and functional knowledge of the Safety products available. They can evaluate the relevance and impact of regulatory changes to the customer’s business, and translate them into the changes to be reflected into their Safety System. They can help the customer carry out the complete impact assessment of any major version upgrade of their Safety System based on their business needs. They can also help translate the business requirements of the end-users into technical specifications and pass them on to the product vendor to help meet the day-to-day compliance needs.
Ultragenic provides the right mix of business and domain expertise
Ultragenic, with its partnership with some of the major Safety solutions providers like Oracle, ArisGlobal and Veeva, has proven to be the trusted partner for its customers to provide business and domain expertise. Some of the critical success factors that work to Ultragenic’s advantage include:
• Domain knowledge – Ultragenic has in-house experts who have deep understanding of PV Operations.
• Business knowledge – The team of experts at Ultragenic are able to elicit user requirements with minimal involvement of the end-user and translate them into technical specifications.
• Regulatory knowledge – The team at Ultragenic has a strong understanding of PV regulations and their applicability on customer’s business.
• Product knowledge – The partnership with multiple Safety system providers puts Ultragenic in a position of having technical and functional knowledge of their products and hence be able to provide adequate techno-functional support to its customers.
Ultragenic Business Support Services
Following are some of the services Ultragenic provides as part of our Business Support Services:
• Business Consulting – Based on their operations and region from which they operate, we help our customers evaluate the relevance of any regulatory changes outlined by various agencies and analyse their impact on the customer’s business.
• Release Assessments – Our customers trust us with performing the detailed impact assessment of major product upgrades on their operations and then working with the product vendor for providing fixes to system related issues identified.
• End-User Support – We help bring efficiencies to our customers’ operations by hand-holding their end users with any issues, analysing their change requirements with minimal involvement from their end, gleaning information from SDEA for system configuration and carrying out the PQ executions on their behalf.
• Business Configurations – We enable the PV operations of our customers by helping them with any configuration updates that can be carried out through their Safety product interface. These include Reporting/Distribution Rules, Auto Narratives, Workflow support, PLS Configurations, User & Access Management, etc.
• Operational Support – We help reduce the turn-around time for issues resolution by becoming the primary support layer triaging, troubleshooting and resolving incidents that we can within our limited access and working with product or hosting vendor for others.
• Reporting Support – We understand that PV compliance boils down to timely submission of various reports to agencies and hence we provide all required support to our customers with respect to design and development of periodic and ad-hoc while also carrying out the analysis and PQ execution for custom reports.
• Governance – We build efficiency, transparency and productivity in the support engagement through metrics-based management, SLA measurement, continuous improvement initiatives and effective end-to-end change management.
Products Supported
• Oracle Argus (On-Prem Implementation, Dedicated Cloud Implementation, Oracle SaaS Cloud)
• Aris Global LSMV Suite of Products
• Veeva Vault Safety
