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Regulatory Compliance
As biotechnology and pharmaceutical companies are held to increasingly stringent regulatory standards, overhead costs associated with compliance requirements have the potential to be overwhelming, particularly in areas such as Validation, ePedigree, SOX, DEA regulations for scheduled drugs, and 21 CFR Part 11.
Providing the right tools for the job, Ross Enterprise solutions enable you to minimize the risks of non-compliance while keeping your operational costs down to maximize profits and enable growth. Our applications reduce the effort, costs, and risks associated with compliance with governmental and industry regulations — from planning activities to execution to documentation of results, our software automates your most critical functions. With all standard processes documented and all operations and results tracked and logged to support your detailed reporting requirements, you can:
- Specify how a product is manufactured
- Manage variability
- Maintain product genealogies
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- Buy, receive, warehouse, manufacture, and sell based on lot level characteristics of potency, two non-linear independent units of measure (e.g., grams/active units), pH, or an unlimited number of customer-defined characteristics
- Maintain and display eSignatures approvals in the lot trace record along with all inventory movements and quality test results
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This list serves as only a sample of how Ross software addresses regulatory requirements your business may be may be facing. But regardless of the specifics of your compliance scenario, we streamline and reduce the cost of your compliance efforts by providing the visibility and control you need by automating:
- eSignatures for Part 11 Compliance
- Audit Trails for GMP and SOX compliance
- Security controls
- GMP
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- Manufacturing
- Materials management
- Quality
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In addition to the information provided on these pages, we also invite you to visit our Life Sciences Resource Library for complimentary document downloads on a range of topics in Life Sciences that may be valuable to you and your organization.
And please remember that regardless of your specialty within the Life Sciences arena, we'd like nothing better than for you to talk to a current client whose business falls in your area of expertise. Just contact us, and we can make that happen too!