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1 The CCO will usually be a person, with a legal and financial background, who has an understanding of enterprise functioning at the broad or big-picture level and also at the detail level She or he should have the appropriate authority within the company, and the CEO, CFO, and CIO should be accessible to her or him The key personnel in the enterprise should also believe in her or his capability and expertise The CCO can be either a consultant or a homegrown officer with a long history in the organization 2 Preferably external Sarbanes-Oxley specialist consultants, so that objectivity and authority are maintained 3 Location refers to the geographic location of a business unit 4 Sublocation refers to specific departments or workgroups within each location or business unit 5 Note that the SLC and SSLC of the implementation team are different from the SLC and SSLC of the audit team, to avoid role conflict

-1 -1 0 1 2 3 4

log Kd(74)

Sarbanes-Oxley Implementation Plan: Developing an Internal Control System for Compliance (Focusing on Sections 302 and 404)

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Figure 717 Surfactant-induced sink asymmetry ratio versus octanol water apparent partition coef cient at pH 74

to the presence of the anionic surfactant in the acceptor wells, with a slight suggestion of repulsion in one case (Fig 717) For ionizable lipophilic molecules, the right pH gradients can drive the solute in the acceptor compartment to the charged (impermeable) form; the uncharged fraction is then further diminished in concentration by binding to the serum protein or surfactant, in the double-sink assay 7533 Simulation Examples Ketoprofen was selected to illustrate the properties of the gradient-pH permeability equation, Eq (734), in a series of simulation calculations, as shown in Fig 718 The membrane-buffer apparent partition coef cients, Kd(pH), were calculated at various pH values, using the approach described in Section 7521 The pH in the acceptor well was pHA 74 in all cases, while that in the donor wells was pHD 3 74 It is interesting to compare the transport properties of ketoprofen under iso-pH (Fig 716) and gradient pH (Fig 718) conditions Under gradient pH conditions, at pHD 3, ketoprofen is mostly in an uncharged state in solution The dashed curve in Fig 718 corresponding to pHD 3 shows a rapid but not extensive decline of the sample in the donor well in the rst few minutes; this corresponds to the membrane loading up with the drug, to the extent of only 9%, compared to 56% for iso-pH 3 conditions The corresponding appearance of the sample in the acceptor well is shown by the solid line corresponding to pHD 3, pHA 74 After a short lag period, the acceptor curve starts to rise rapidly, mirroring in shape the donor curve, which decreases with time The two curves cross at 7 h, whereas in the

n effective internal control system is integral to the ability to comply with Sarbanes-Oxley An internal control system is what will reduce the likelihood of noncompliance and alert the company to breaches, failures, or weaknesses in the system that must be addressed Internal controls as preventive and detective measures are the front line for ensuring that the regulatory requirements are being met, and thus much thought and consideration must be put into developing and maintaining those controls The following is a guide for achieving just that

09 08 07

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An internal control system that meets the requirements of SarbanesOxley can be developed by following an eight-step process When a compliance plan is structured in this way, the journey to compliance is easy, and the system is easily implemented and followed The eight steps are: 1 2 3 4 Establish a compliance committee Assess risk Set reporting objectives Prepare a formal implementation plan 169

C(t) / CD(0)

pH 5 (8%) pH 4 (9%) pH 3 (9%) pH 6 (5%)

170 5 6 7 8