ERP Risk and Compliance Solution

• Standardise overall control framework across your organisation
• Create centralised repository of risks and controls.
• Efficient execution, documentation and testing of system-defined controls.
• Certify and sign off on controls

The increasing complexity of ERP’s software applications, adds to the risk of security threats, with evolving technology, new functionality, and web-based solutions.

PwC helps you address key issues:

• How to identify Segregation of Duty conflicts and what is adequate segregation?
• How to balance the inconvenience of access controls and productivity?
• How to monitor the use of powerful system functions and unauthorised access to confidential information on a continuous basis?

We show you how to manage and control information and transactions from initiation to reporting, using the right mix of automation and manual techniques. The result: the reliability, integrity and trust you have a right to expect.

As a part of Master Data Review, we assist clients in performing review of masters with specific focus on key fields, duplicity, redundancy, inconsistency manually/ using PwC developed automated scripts to identify clean-up issues. We provide recommendation on clean-up of master data to identify & remove redundant data, duplicate data, inconsistent data, inactive data etc. Masters that are covered as a part of review are Customer Master, Vendor Master, Material Master, Tax master, GL Master, Employee Master, Asset Master, Pricing Master, BOM Master, Freight Master etc. Master data review helps clients to have more reliable data capturing more accurate records and also ensures consistent and non-duplicate master data.

PwC’s dedicated Regulatory compliance team has the pharmaceutical expertise to support our customer to implement key controls to ensure when the client compliance is outsourced to PwC, all our service on delivered in accordance with the clients’ policies for meeting industry regulations.

PwC Offerings in Pharma Compliance

Technology and Compliance Consulting

• Computer System Specification , Selection, Configuration & Implementation
• Computer System Validation
• Commissioning and Qualification
• 21 CFR Part 11 Compliance

Quality Assurance and Process validation

• Definition for Quality policy, related responsibilities, SOP & batch record review,.
• QS benchmarking, Corrective & preventive action (CAPA) planning & executions
• Equipment qualification
• Process: performance qualification
• Product: Operational & Performance Qualification
• Quality Assurance System for revalidation

IT Infrastructure Qualification

• IT Infrastructure Qualification Plan
• Network Qualification
• Local Area Network Qualification
• Qualification of server room
• Operating System & database Qualification