Compliance Consulting

Computer System Validation (CSV):

In the pharmaceutical, chemical and food industry computer systems are increasingly deployed in areas which are regulated by law (EU, FDA). These legal requirements (GMP, GLP...) call for the validation of computer-supported processes and the qualification of the used hardware, networks, etc. Requirements for the validation of computer-supported systems have existed for nearly 20 years.

Sarbanes Oxley Act (SOX):

SOX 404 requires the disclosure of an annual report by management on internal controls, attested by external audit firms. SOX 404 can have various significant implications for multinational companies, such as the implementation of internal control mechanisms, which typically affect processes (process controls) and systems (e.g. SAP authorization controls).

Lodestone has deep expertise in ensuring that SAP implementations satisfy these requirements and are easily maintainable:

• "Validation Management Guide" to supplement the standard SAP implementation method (ASAP)
• Templates and accelerators to standardize and simplify validation and SOX
compliance of SAP implementations
• Integration of "best fit" validation and SOX approach into chosen off-shoring model