Services

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Quality Management System Support

Conduct an initial assessment and gap analysis.
Develop QMS implementation or upgrade plan.
Draft and revise quality documentation, including policies, procedures, and templates.
Establish document control processes.
Implement core QMS processes like change management, CAPA, and internal audits.
Define and monitor key performance indicators (KPIs) to evaluate QMS performance.
Facilitate management reviews to discuss QMS performance and improvement opportunities.

Review and update all quality documentation to ensure it meets current regulatory standards.
Conduct a mock audit to identify and address potential areas of non-compliance.
Ensure all procedures, records, and CAPA documentation are complete, organized, and accessible.
Prepare key personnel for interviews by reviewing role-specific questions and responses.
Verify that all employee training records are current and relevant to QMS and regulatory requirements.
Establish process to handle communication and documentation during the certifications and inspections.

Develop an audit schedule and plan based on risk assessment and compliance requirements.
Create standardized audit checklists for internal processes and supplier requirements.
Conduct audits to evaluate adherence to quality standards and identify process improvements.
Document audit findings and prioritize corrective actions for both internal and supplier observations.
Track and verify the completion and effectiveness of corrective actions to ensure lasting compliance.
Develop tools to maintain records of all audits, findings, and follow-up actions.

Identify applicable regulations and industry standards (e.g., ISO, FDA, TGA) for the organization and its products.
Conduct a gap analysis to evaluate current compliance status against requirements.
Develop or update quality policies and procedures to ensure alignment with regulations.
Provide training to staff on regulatory requirements and compliance responsibilities.
Assist with audits and inspections by regulatory bodies.
Implement corrective actions for any regulatory findings and track progress.

Establish a standardized process for identifying, documenting, and categorizing nonconformances.
Develop templates for NC and CAPA reports to ensure consistency in documentation.
Train staff on identifying nonconformances and initiating CAPA investigations.
Implement root cause analysis tools (e.g., 5 Whys, Fishbone Diagrams) to determine the cause of nonconformances.
Set up tracking and monitoring systems to review NC and CAPA status, timelines, and effectiveness.
Establish process to conduct regular reviews to evaluate CAPA effectiveness and identify recurring issues

Define supplier quality requirements and criteria based on standards and regulatory requirements.
Develop a supplier qualification and onboarding process, including assessments and audits.
Create a supplier performance monitoring system with key performance indicators (KPIs).
Establish a process for managing and addressing supplier nonconformances and corrective actions.
Implement supplier scorecard to track performance and support continuous improvement.
Conduct regular supplier audits and reviews to ensure adherence to quality standards.
Provide training and resources to suppliers on quality expectations and regulatory requirements.

Establish document control procedures, including version control, approval workflows, and access permissions.
Develop templates and naming conventions to standardize documentation across the organization.
Implement a centralized system for storing, managing, and retrieving controlled documents.
Define change control procedures, including change request initiation, impact assessment, and approval steps.
Set up tracking for document revisions and changes to maintain audit trail.
Train employees on document control and change management processes.
Establish process to conduct periodic reviews to ensure document accuracy and relevance, removing obsolete documents when needed.

Identify and document potential risks across processes, products, suppliers, and regulatory compliance.
Perform risk assessments using tools like Failure Modes and Effects Analysis (FMEA) or risk matrices to evaluate impact and likelihood.
Develop risk mitigation strategies, including preventive actions and controls to minimize risk occurrence.
Implement monitoring systems to track key risk indicators and detect early warning signs.
Establish a process for reviewing and updating risk assessments periodically and after significant changes.
Conduct risk management training for staff to ensure awareness and adherence to mitigation processes.

Assess current feedback and complaint management processes, identifying gaps and improvement areas.
Develop and implement a standardized process for logging, categorizing, and tracking customer complaints.
Guide the organization in establishing clear timelines, roles, and responsibilities for efficient complaint. acknowledgment, investigation, and resolution.
Conduct training sessions on root cause analysis techniques to address underlying issues and prevent complaint recurrence.
Set up complaint tracking and monitoring tools to analyze metrics, identify trends, and drive continuous quality improvements.
Ensure documentation practices comply with regulatory requirements.

Develop an asset inventory system and define procedures to track equipment details, location, and maintenance requirements.
Establish calibration and preventive maintenance (PM) schedules based on equipment specifications and usage.
Implement a tracking system for calibration and PM activities to ensure timely and accurate servicing.
Define procedures for managing and investigating impact of out-of-tolerance conditions.
Train staff on proper asset handling, maintenance, and calibration processes.

Develop and implement equipment qualification processes.
Establish a validation process for computerized systems and software that meets regulatory requirements (e.g., GxP, FDA 21 CFR Part 11).
Implement a risk-based approach to prioritize qualification and validation activities.
Create standardized testing and documentation processes to validate system functionality, security, data integrity, and compliance.
Develop change control processes to manage updates or modifications to qualified equipment and validated systems, maintaining compliance and documentation accuracy.