Rescop - Regulatory Compliance and Validation Solutions

Rescop offers innovative products and services for establishing and maintaining compliance of computerized systems with G×P regulations. Our core business is the development of software products to control, support and integrate computerized system compliance processes. Besides these software products, we provide services in the field of computerized system compliance including consultancy, training, hiring and audits, and assessments.

ENTERPRISE COMPLIANCE MANAGEMENT SYSTEM (RC-ECMS)

To support companies in compliance and validation, Rescop has developed a software product: the Enterprise Compliance Management System (RC-ECMS). RC-ECMS is a corporate web-based database solution, which controls, supports and integrates the processes required for establishing and maintaining GxP compliance of a company's computerized systems throughout their entire lifecycle.

Supported regulations include 21 CFR part 210 and 211, 21 CFR part 58, 21 CFR part 820, 21 CFR part 11, Eudralex volume 4-medical products for human and veterinary use: good manufacturing practice, and OECD principles on good laboratory practice, ICH Q7A.

Computerized systems supported by the RC-ECMS include:

• Lab equipment
• Medical devices
• Process control systems
• IT infrastructure
• Information systems

RC-ECMS MODULES

RC-ECMS is based on modules per compliance process.

ASSET AND CONFIGURATION MANAGEMENT

• Custom overview on the company’s computerized systems and their components
• Registration per system of its characteristics, involved people and its components including hardware, software, equipment, users and documentation
• Baseline reporting

CONTROL COMPLIANCE: VALIDATION MASTER PLAN

• Generate and maintain validation master plans
• Automated workflow for creation, review, approval and authorization of plans

ESTABLISHING COMPLIANCE: VALIDATION

• Generate an appropriate validation approach for a given system
• Validation dashboard providing an overview on the validation process and access to the corresponding documents
• Automated workflow for creation, review, approval and authorization of documents
• Design and manage requirements, risk items and test cases
• Design assistance
• Repository with good examples
• Import requirements, risk scenarios and test scripts from repository or previously generated documentation
• Test registration and non-conformance handling

MAINTAIN COMPLIANCE

Use, maintenance, cleaning, calibration, periodic inspection, call incident and problem management, training, backup and restore, security, archiving, system administration and business continuity.

• Scheduling and triggering of activities
• Registration of results in logbook, incl. attachments
• Trend reporting

Change control, periodic review and retirement:

• Integration with email system for notifications / reminders
• Generate an appropriate approach for a given system
• Generation of required documents
• Design assistance - automated workflow for creation, review, approval and authorization of documents

MONITOR COMPLIANCE: MANAGEMENT REPORTING

• Overviews on the compliance state of computerized systems
• Overviews on running compliance processes
• Custom reporting
• Performance measurement based on KPIs

RC-ECMS offers the following advantages.

ENSURE COMPLIANCE

RC-ECMS offers functionality to easily create and maintain computerized system compliance documentation. Compliance is ensured through standardization of documentation, automated workflow, scheduling and alerting.

With RC-ECMS a company will be in control of its systems through an up-to-date overview of the systems, their configuration, their compliance state and (progress of) compliance processes. Moreover, RC-ECMS serves as a central point for managing compliance processes and data. All documented evidence required to demonstrate the compliance state of a given system can be retrieved directly from the system.

ESTABLISH AND MAINTAIN COMPLIANCE EFFICIENTLY

RC-ECMS offers a lot of efficiency gains through the integration of compliance processes and data. Moreover, compliance processes are optimized through the content, document- and workflow management functionality of the system. Last but not least, RC-ECMS is 21 CFR Part 11 ready, which enables paperless compliance.