Business Risk Consulting

The threat landscape is ever changing and so are the business priorities. With business models changing and increased transparency the organisations are feeling more pressed than ever to operate in the dynamic, regulated and customer centric ecosystem.

There has been a drastic shift in the way organisations operate, sustain, grow, and stay competitive in the business by being agile, diversified, adaptable and responsive to the changing environment. This has made organisations relook into their priorities by setting up a robust business continuity management and resilience framework.

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Computer System Validation (CSV), mainly in the pharmaceutical and life sciences industry, is required to validate the system that can impact patient safety and drug/product quality. However, In the absence of CSV, the organisation faces the risk of non-adherence to compliance resulting in delay to the market introduction and/or damaged reputations of the organisation. Having an insufficient and/or inadequate validation strategy, isolated validation execution due to improper knowledge of system and process, and incomplete integration of compliance with the product and process could lead to an deficient compliance standard, which could raise a question on the entire validated system. Moreover, following the same approach of validation for every process, equipment and software will always result in more time-consumption, increased cost and underutilisation of the resource. So, we at PwC with our quality and validation CoE, enable clients to validate/commission their systems with fit-for-use and agile validation strategies to ensure agility is achieved without compromising quality. We do this with PwC's many tools and accelerators developed for the years including reusable global templates for systems such as S4 HANA, QMS applications, quality controls systems including Chromeleon, Empower, manufacturing equipment amongst others.

Our Key services under CSV are:

1. CSV Managed Services
2. End-to-end computer system validation
3. Commissioning and qualification for equipment
4. GxP and ERES assessments
5. Infrastructure and network qualification

With the rise of the digital era, personal data turned into fuel, and therefore it is very important to know how the data is getting collected and processed. Data privacy in particular focuses on appropriate and fair collection, processing, storage, access, security, retention, and sharing of the personal data. It is a discipline that involves laws, guidelines and rules and best practices to attain acceptable privacy.

Organisations are buried under an exponentially growing mountain of information and yet are also increasingly being held accountable for how the information is used, distributed, retained and protected. The consequences of failing to know and control your information are getting heavier and more public. We provide various data lifecycle management services to our clients such as data privacy gap assessments, data privacy framework design & implementation, enhancing tech design & advisory services along with the managed services. We offer privacy framework design and implement strategy through execution by helping organisations comply with regulations such as GDPR, Data Protection Bill, and other privacy-related regulations. PwC brings Data Privacy and Protection together to provide a holistic approach to data risk that allows organisations and their customers to trust that due care is being taken with their most sensitive and valuable data assets.

Controls during an ERP implementation or transformation are predominantly neglected and looked at as an afterthought prior to an external review or audit. We enable clients to design/redesign, implement and operate a robust control framework and security environment across their ERP landscape.

We provide these services as part of the ERP implementations itself as well as ongoing monitoring/assessment and one-time reviews. We help clients in designing SoD (segregation of duties) and SAT (sensitive access transactions) rulesets as well across ERP applications, analyzing the risks and helping them remediate or mitigate the same.

Technology continues to take a centrestage for an effective and efficient functioning of the Governance, Risk and Compliance functions for the organisations. Our GRC Technology practice boasts of rich Industry and Domain knowledge that helps organisations in identifying technology requirements to support their GRC processes, designing & automating GRC processes, selecting vendors, implementing technology platforms, and performing a post deployment review to assess operating effectiveness, migration/modernization etc. Through our GRC Tech COE we also offer end to end services including “managed services” to run your Governance, Risk, Compliance, Policy and Audit processes across domains such as Financial Risk and Regulatory Processes (including Basel, IFRS, Fraud etc.), Operations Risk, Regulatory Reporting - Financial and Compliance Reporting, ITSM, DevOps, SecOps, TPRM, BCM, ESG, ITAM, ITOM etc.

Our clients have realised significant benefits by reducing non-compliances and cost of compliance as a result of our solutions and services.

• Focused GRC Solutions: ServiceNow, RSA Archer, Workiva, Metric Stream, Oracle OFSAA, SAS GCM, SuryaSoft, SAP GRC, OneTrust, Clarify, Actimize etc.

IT is a fundamental part of your business, and you need to establish and sustain trust in your IT. We can help you focus on fundamental as well as emerging IT issues. Our services are based on insights into how leading organisations prioritise their efforts to ensure that IT investments provide maximum security and risk mitigation in the most cost-effective manner.

In addition, we help our clients in managing IT risks to address all of their IT risk and compliance requirements. We help clients with IT General Controls (ITGC) testing, IT Service Management (ITSM), IT Audits, Application Controls & Security, SOX and other regulations related control testing, IT SOP Definition, IT Outsourcing and PMO Advisory, IT effectiveness & strategy and many more services. As part of PMO services, we help clients manage the planning, organisation, and accountability of IT projects to achieve their information technology goals, by getting involved in the whole lifecycle of the IT projects.

At PwC, we understand that governance of IT Assets plays a vital role in enabling organisations to reduce cost, improve efficiency, optimise asset utilisation for maximum returns and compliance. With an overall experience of 3000+ engagements across multiple sectors, the LMCC team has worked in a variety of areas including (but not limited to) compliance reviews, licence cost optimization, Free & Open Source Software (FOSS) compliance and process maturity assessment.

We also offer our in-house developedtool (AIM) which is a tailor made ITAM solution for customers in conjunction with the rich experience of our subject matter experts adept in managing over 250+ publishers. Additionally, our pool of SMEs can help in maximising the benefits from already deployed ITAM tools in the customer environment.

Our proven methodology along with intelligent automation empowers our clients with the following business use cases

• Generate cost optimization opportunities
• Minimise incremental cost during each renewal
• Pre-emptive identification and remediation of potential non-compliance
• Process development for effective IT asset management
• ITAM Maturity Assessment and roadmap for improving maturity rating
• Real-time data tracking of IT assets using agent based and agentless approach
• One-stop contract repository for publisher-wise software spends
• Custom email notifications for upcoming contract renewals and maintenance payouts
• Integrate IT asset management tool with other available inventory tools like SCCM, CMDB, ITSM
• Application discovery and tracking of licence utilisation along with re-harvestation opportunities
• Identification of Blacklisted and End of Life software
• Publisher-wise compliance risk and cost optimization opportunities
• Vulnerability Identification and Malware Detection
• Free and Open Source Software (FOSS) assessment

The lack of a comprehensive quality management system in the organisation creates serious inefficiencies in managing SLAs within the organisation to close deviations, manage audits and perform appropriate root-cause-analysis to identify corrective and preventive actions. There is an increased probability of variances and discrepancies in the adherence of the process if there is no defined framework that assures effective quality management. The inefficiencies and lack of standard control and oversight on the quality management processes have the potential to result in significant losses in revenue and pose a risk of failure to comply with applicable regulations. The key is to reduce inefficiencies and be on top of quality processes by having a comprehensive point of view on all quality processes enabled by technology.

PwC provides its clients with below primary services under its Quality agenda:

1. Process design/re-design of the quality management processes
2. Implementation of QMS process in software solutions
3. Support services for QMS software solution
4. Process design/ re-design of the quality control lab processes
5. Implementation of quality control lab processes in Laboratory Information Management System (LIMS)
6. Support services for LIMS software solution
7. QMS Managed Services
8. Supplier assessments

Using PwC's many tools and accelerators, we help clients with these above services. We not only believe in only designing and implementing the QMS process for our clients but also help them sustain it with help of our managed services offering.

As organisations are undergoing rapid risk and regulatory transformations, the higher expectations from board & senior management are leading the companies to undertake the enterprise wide risk transformation journey. This is because of increased regulatory scrutiny and newer legislations, increased cost pressure across business functions and disruptions & uncertainties forcing agile risk management systems.

Our risk transformation practice is dedicated to helping organisations manage risk as organisations are undergoing and rethinking the risk. We provide comprehensive solutions that address risk management, compliance, and regulatory requirements, using a combination of advanced technology, data analytics, and industry-specific knowledge.

Our goal is to help clients optimise client’s risk management strategies, reduce costs, and improve business performance. We provide various services in this domain such as Enterprise Risk Management Maturity Assessment, Control Maturity Assessment, Continuous Control Monitoring, Automation Maturity Assessment and many more