Management compliance

Plastics Engineering 55, No.7, July 1999, p.67 ENVIRONMENTAL-REGULATION COMPLIANCE MANAGEMENT... 

The scope is briefly outlined of Chemmate 3.1 from Atrion International, which integrates environmental modules obtained through the company s acquisition of Chemtox and Environmental Software Associates. The software system, which is directed to the environmental, health, safety and transportation sector is claimed to be the first commercially available end-to-end regulatory compliance management solution. 

Examples of GxP processes (functions) include supplier management, procurement, goods receipt, materials management, production control, quality control, batch release, distribution, recall, customer complaints, batch tracking, and compliance management (e.g., SOP management, electronic data archiving). 

Examples of product quality GxP data include study data (e.g., stability trial data, clinical trial data, patient and animal records/results), regulatory submissions (e.g., stability data, development summary reports), analytical production data (e.g., analytical methods, quality reference data), and compliance management (e.g., indexes to archived documents/records). 

The maintenance of the validated state entails an effective compliance management system that includes (but is not limited to) ... 

Compliance management opens up a potential opportunity for pharmacists to become directly engaged in pharmaceutical care and not allow the linkage between measurements and care to default to another professional group, as occurred in IDDM. If pharmacists correctly position their compliance-related activities, they could develop a much stronger partnership with the prescriber, though it will require a clear definition of the roles of the physician and the pharmacist (Metry and Meyer, 1999). 

Executive Director, Worldwide Policy and Compliance Management, Johnson Johnson, United States... 

Dr. Guy Wingate Computer Compliance Manager Glaxo Wellcome March 2000... 

Worldwide Policy and Compliance Management New Brunswick, New Jersey... 

TSCA s scope makes compliance a daunting challenge. In the last nine years, EPA brought an average of 198 enforcement actions each year, or more than one every other day. As these statistics indicate, companies both big and small continue to stru e in creating effective compliance solutions. The increasing speed and competitiveness of the current business climate add yet another hurdle for compliance managers. 

In the environmental field, the United States Environmental Protection Agency (EPA) established its Incentives for Self-Policing Discovery, Disclosure, Correction and Prevention of Violations (Audit Policy). It permits complete mitigation of civil penalties if the violator complies with aU of its requirements, one of which is discovery of the violation through either an audit or application of a compliance management system. 

Procedures for the prompt and appropriate correction of any violations, and any necessary modifications to the. .. compliance management system to prevent future violations. 

Most EPA Regional offices apply these criteria strictly, and ask probing questions of companies seeking to take advantage of the Audit Policy benefits. In at least one instance the EPA seriously questioned whether a compliance management system could qualify because it did not require feedback to a person who initiated a request for a change to confirm that the change had been made properly. The requirement of a feedback loop is not explicitly stated in the Audit Policy, but is necessitated by it. ... 

Systematic Discovery of the Violation Through an Environmental Audit or a Compliance Management System... 

To meet this criterion, a company must have discovered the potential violation through either an environmental audit or through appHcation of a compliance management system. While the Audit Pohcy describes compliance management systems in detail, its definition of audit is fairly cursory. 

In contrast to its relative silence on what constitutes an audit, the EPA detailed its concept of a compliance management system that meets the Audit Policy requirements. Such a system must have six elements, designed to motivate employees to prevent, detect and correct violations ... 

The Audit Policy does not say much about what a company must do to prevent recurrence of the violation, other than that it may need to improve its auditing program or compliance management system. 

Any penalty remaining after application of the Audit Policy can be further reduced by the amount of a SEP. The SEP cannot be one that is required to meet the Audit Policy criteria for example, it cannot be institution of a compliance management system if that is necessary to prevent future violations under the sixth criterion of the Audit Policy. " ... 

Well documented and soundly thought out compliance management systems and policies indicate a thorough TSCA compliance approach. 

Fed. Reg. 19618,19625 (Apr. 11,2000). Complete penalty waivers are also available if the violation was discovered as part of the appUcation of a compliance management system, but that will rarely be apphcable in the context of a pre-divestiture audit. 

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