Compliance – Law and regulations Management
This suite covers all aspects of compliance with Laws and regulations as well as the management of change management, through evaluations, audits and documents, with the consequent corrective and preventive actions that may be necessary. All cause analyzes of these nonconformities are performed in this suite through established or customer-specific methodologies.
Quality Management Processes of the Life Sciences Industry
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Document Management
Internal Controls such as standards, procedures, fact sheets, drawings, work instructions, preventive maintenance, security, others, and can be used locally or corporately within the company. External controls (suppliers of products and services) such as: Standards, Procedures, Good Manufacturing Practices – GMP, Certifications, Licenses, Contracts and other documents according to the quality policy of the company. Most common examples: ISO 20000, Hazard Analysis and Critical Control Points (HACCP), Environmental Licenses, Operating License, Production License, Supply Contracts, Licenses of public agencies such as Federal Police, Military Police, IBAMA.
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Assessment / Audits
Apply and manage audits performed in the internal processes and also in the suppliers of services, products and spare parts. Control of results and upcoming audits. Follow-up actions. Example of audits: Production Process / Self-Assessment / Quality System / Environmental Audits / Price Level / Negotiation flexibility / Communication / ISO 22000 / Risk Analysis and Critical Control Points / others.
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Non-Compliance and Correctives / Preventives actions Management (CAPA)
To manage the process of solving problems and non-conformities detected in the audit and / or evaluations, through methods such as 8D, 5PB’s, among others, where the nonconformity generator itself responds to the phases of the applied method, drastically reducing the workload of the Quality area of the company.
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Change Management
This module allows all changes to pass through a flow of tasks where they will be evaluated and, if within the Good Manufacturing Practices, approved. This module aims to provide that all changes are made in an agile and correct manner, minimizing impacts arising from unforeseen events.
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Indicators
Quality Competitive Intelligence. PPM, Average, Standard Deviation, Dispersion, Failure Trends, IDF, Audit Grades. Pareto Charts, Trends and management reports.