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The complex alignment of business, quality, compliance and validation procedures and processes provides a critical management challenge for all types of organisations.

Addressing these challenges cost effectively, ComplianceControl Centre not only provides significant business advantages in terms of both cost and enterprise-wide efficiencies, but also delivers the opportunity to implement common policies and procedures and ensure that standards are set, followed and maintained.

With a single, secure database that is visible to key players across your organisation, guaranteed conformance, continued convergence and the use of correct terminology can be taken for granted. Certifying entire project life-cycle conformity becomes straightforward and non-compliance issues, audits and corrective actions are easily identified, tracked and managed.

Functionality includes:

•  Fully Validated Electronic Quality and Document Management System, compliant with 21 CFR Part 11.  

•  The Quality Module covers CAPA, Risks, Deviations, Audits, Complaints and Training Records.  

•  The Projects Module enables a wide range of projects to be managed and controlled, and includes Documents, Equipment, Facilities, Hardware and Software.

•  The Alert module is integrated to e-mail ensuring that key activities are visible and actions are completed to ensure Compliance.

•  The Monitor module gives complete Compliance visibility through an easy to view traffic light dashboard, ensuring any non compliant items are made visible immediately.

Benefits:

•  A single on-line repository for all mission-critical compliance data, for total control over all regulatory matters

•  Saves weeks if not months of time preparing for audits. On going audit data is readily available.

•  Empowers key decision makers with real-time visibility and control over the quality and compliance status of the organisation

•  Delivers Key Compliance Indicators that are essential to ensure successful inspection and audits

•  Ensures conformance, convergence and correct terminology when projects are created and deliverables entered

•  Delivers major cost efficiencies via benchmarked standards that are established and maintained across the enterprise

•  Includes projects, documents, data, systems, manufacturing and laboratory systems status; internal and external audit tracking with visible risks, changes and tasks.