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Regulatory consulting

Regulatory consulting

Over the past few years, computer system compliance has been a major topic of discussion in the life sciences industry. Whether the discussion is based on computer system validation, 21 CFR Part 11 compliance, system security, privacy or data integrity, the issues are not limited to application software only, but apply even more to the performance and management of these activities in a value-added, cost-effective manner.

Deloitte supports companies in the life sciences industry to comply with today’s complex regulatory environment for computerised systems.

Our validation consultants work together with you and the system implementer to validate your computer systems. We are experienced not only in computer system validation but also in risk management and project management, key success factors for this area. Deloitte’s proprietary Fasttrack© validation methodology has been used for SAP, J. D. Edwards, PeopleSoft, Oracle and other ERP systems, as well as document management systems, LIMS, and many other system types. We leverage this methodology when developing a validation strategy to meet your validation standards in a risk-based and pragmatic fashion.

Always an integral part of our computer validation projects but often provided as a separate service are our quality control (QC) and quality assurance (QA) services. They provide QC and QA review of validation projects in accordance with your company’s validation methodology and in compliance with applicable predicate rules, computerised system regulations such as 21 CFR part 11 and known industry standards.

We also offer regulatory compliance audits both of your internal organisations and departments as well as of your most important external business partners (vendor audits). Internal audits provide a benchmark indicating to what extent your systems comply with applicable regulations and internal policies and procedures. External audits aim to ensure that computerised systems used or developed by your business partners are properly validated and documented. These audits not only prevent non-compliance because of compliance deficiencies at your business partner but also leverage as much as possible the validation effort based on the outcome of the audit.

Our clients value our independent opinion and clear language when assessing systems' regulatory compliance.