Combined Audit & CAPA Management

Auditing provides the essential validation of business practice

Auditing Functions that maintain the links to the evidential trail.

Audit Programme

  • Features: Develop and manage comprehensive audit programmes.
    Benefits: Streamline audit planning and execution, ensuring thorough and systematic compliance checks.

Audit & CAPA Results

  • Features: Track Corrective and Preventive Actions (CAPA) and audit outcomes.
    Benefits: Identify areas for improvement and ensure corrective actions are implemented effectively.

Checklists and Management

  • Features: Utilize and manage predefined and custom checklists.
    Benefits: Enhance consistency and thoroughness in audits and inspections.

CAPA / Nonconformance

  • Features: Identify non-conformances and implement CAPA procedures.
    Benefits: Address and resolve compliance issues promptly to maintain standards.

Training and Competency

  • Features: Track training progress and assess competencies to ensure compliance.
    Benefits: Ensure employees are adequately trained and competent in their roles, reducing compliance risks.
Frequent process and compliance auditing using mobile checklists offers several advantages that can streamline operations, increase compliance rates, and reduce potential risks for organizations. Here are the benefits of using this approach: 1. **Accessibility**: Mobile checklists can be accessed from anywhere, anytime. This flexibility is especially valuable for auditors or inspectors who are in the field or at remote locations. 2. **Real-time Data Collection**: Mobile checklists allow for immediate data input, ensuring that observations, images, or notes are captured in real-time, reducing the likelihood of missing or forgetting details. 3. **Efficiency**: Electronic checklists can auto-populate data, timestamp entries, and quickly navigate between sections, making the audit process faster and more streamlined. 4. **Consistency**: Mobile checklists ensure that all auditors follow the same guidelines and criteria, leading to consistent and standardized audits. 5. **Automated Reporting**: Once an audit is complete, mobile apps can automatically generate reports, graphs, or summaries, reducing the time required for post-audit paperwork. 6. **Timely Notifications**: Auditors and management can receive instant notifications for non-compliances or critical issues, allowing for swift corrective action. 7. **Reduction in Paperwork**: Digital checklists eliminate the need for paper, leading to cost savings and reduced environmental impact. 8. **Enhanced Data Integrity**: Mobile checklists reduce the risk of manual data entry errors, ensuring that audit results are more accurate. 9. **Trend Analysis**: With data being stored electronically, organizations can easily analyze trends over time, identifying areas of consistent non-compliance or potential risks. 10. **Increased Accountability**: Mobile checklists often have features like user sign-ins or location tagging, ensuring that auditors are accountable for their work. 11. **Scalability**: Mobile audit checklists can be easily updated or expanded to include new compliance areas or processes without the need for reprinting or redistributing physical checklists. 12. **Secure Storage**: Data from audits can be securely stored in cloud databases or enterprise servers, ensuring confidentiality and reducing the risk of data loss. 13. **Cost Savings**: Over time, using mobile checklists can lead to cost savings by reducing paperwork, minimizing data entry errors, and identifying non-compliance issues before they become more significant problems. 14. **Improved Compliance**: Frequent auditing reinforces the importance of compliance, ensuring that standards are consistently met and maintained. 15. **Enhanced Stakeholder Confidence**: Demonstrating a commitment to regular process and compliance auditing can boost confidence among stakeholders, be they customers, investors, or regulatory bodies. In essence, frequent process and compliance auditing using mobile checklists modernizes the auditing process, making it more efficient, accurate, and responsive. As businesses and regulations evolve, mobile checklists provide the agility and precision needed to ensure that processes remain compliant and operations run smoothly.

Frequent process and compliance auditing using mobile checklists:

  • Simple format for any user
  • Linked to system records for traceability
  • Receive valuable audit information instantly.
  • Create your own specific audit templates
  • Define an audit scoring mechanism to pass, warn or fail on a result
  • Simple to follow yes/no answering with scored audit results
  • Add audit detail when needed
  • Receive instant notification of the result of the audit
  • Dashboard audit reporting.

Professional QMS, ISO, process, compliance & product auditing and quality assurance using logical checklists:

  • Build comprehensive audit templates
  • Auditing is linked to system records for traceability
  • Conditional logic allows for enhanced audit information harvesting
  • Define an audit scoring mechanism to pass, warn or fail on a result
  • Simple to follow answering with scoring
  • Add audit detail when needed and photos to audit questions
  • Task generation linked to individual audit questions
  • Receive instant notification of the result of the audit
  • Dashboard audit reporting.
Professional QMS (Quality Management System), ISO, process, compliance, and product auditing, when combined with quality assurance using logical checklists, can have a profound impact on an organization's efficiency, credibility, and overall performance. Here are the benefits of this integrated approach: 1. **Standardization**: Logical checklists ensure a standardized approach to auditing and quality assurance, enabling consistency across all audits and evaluations. 2. **Enhanced Quality Control**: Logical checklists guide auditors through a structured process, ensuring that all critical areas are examined, leading to comprehensive quality control. 3. **Efficiency**: Checklists streamline the audit process by clearly defining what needs to be assessed, reducing the time and effort required for audits. 4. **Reduced Errors**: Checklists minimize the chance of overlooking critical elements, reducing human error and ensuring more accurate audits. 5. **Compliance**: Professional auditing of compliance standards, such as ISO, ensures that the organization meets international and industry-specific requirements, which can be essential for market access and customer trust. 6. **Continuous Improvement**: A robust QMS promotes a culture of continuous improvement. Regular audits identify areas of potential enhancement, driving innovation and efficiency. 7. **Increased Credibility**: Professional ISO and product auditing can lead to certifications or accreditations, enhancing an organization's credibility in the eyes of customers, partners, and stakeholders. 8. **Risk Management**: Audits identify potential risks in processes or products, allowing for proactive measures to mitigate or eliminate those risks. 9. **Objective Feedback**: Logical checklists provide objective criteria for evaluations, ensuring that feedback is unbiased and based on facts. 10. **Cost Savings**: Identifying non-compliances or inefficiencies early on can prevent costly mistakes or rectifications later, leading to long-term cost savings. 11. **Clear Communication**: Checklists act as a communication tool, ensuring that all team members, departments, or even external auditors understand the standards and criteria being applied. 12. **Data-Driven Decisions**: Systematic auditing and quality assurance provide valuable data that can guide decision-making, from process improvements to resource allocation. 13. **Stakeholder Confidence**: Regular and thorough auditing combined with demonstrable quality assurance practices can boost confidence among investors, customers, and other stakeholders. 14. **Competitive Advantage**: Organizations that can demonstrate rigorous quality management and compliance practices can differentiate themselves in the market, offering a competitive advantage. 15. **Employee Morale and Engagement**: A clear commitment to quality and compliance can boost employee morale, as staff can take pride in their work and the products or services the organization delivers. 16. **Scalability**: Logical checklists can be easily updated to adapt to changing regulations, standards, or organizational needs, ensuring that the auditing process remains relevant and effective. 17. **Transparency**: Professional auditing and quality assurance practices promote transparency, ensuring that internal and external stakeholders have a clear view of the organization's performance and adherence to standards. In summary, the integration of professional QMS, ISO, process, compliance, and product auditing with quality assurance using logical checklists offers a structured, standardized, and efficient approach to ensuring organizational excellence. This combination drives continuous improvement, ensures compliance, boosts stakeholder confidence, and ultimately contributes to the organization's success.
The ability to configure custom ISO QMS (Quality Management System) & compliance audit templates, combined with the scheduling of QMS audits for specific dates, departments, and auditors, provides several advantages for organizations striving for consistent quality and compliance. Here are the benefits of such an approach: 1. **Tailored Audits**: Customizable templates allow organizations to cater the audit content specifically to their unique operational requirements, ensuring relevancy and efficiency. 2. **Enhanced Focus**: Scheduling audits for specific departments ensures that each area of the organization is audited with a specialized focus, catering to the nuances and specificities of that department. 3. **Consistent Standards**: Using ISO QMS as a foundation ensures that the organization adheres to internationally recognized standards, boosting credibility and ensuring high-quality operations. 4. **Resource Efficiency**: Scheduling audits in advance allows for better allocation and utilization of resources, ensuring that the necessary personnel and tools are available on the audit day. 5. **Accountability**: Assigning specific auditors to particular audits enhances accountability, as roles and responsibilities are clearly defined. 6. **Operational Continuity**: By scheduling audits on specific dates, departments can prepare in advance, ensuring minimal disruption to daily operations. 7. **Continuous Improvement**: Regularly scheduled audits ensure that quality management and compliance are continually assessed and improved upon, driving operational excellence. 8. **Clear Communication**: Knowing the audit schedule in advance ensures that all relevant stakeholders, from department heads to floor staff, are informed and prepared. 9. **Reduced Non-compliance Risks**: Customized and scheduled audits make it more likely that non-compliances will be identified and addressed promptly, reducing potential risks and liabilities. 10. **Time Management**: For auditors, knowing their schedule in advance allows them to manage their time more effectively, allocating sufficient time for pre-audit preparation and post-audit reporting. 11. **Better Preparation**: Departments being audited can prepare in advance, ensuring that all necessary documentation and processes are in place for the audit. 12. **Flexibility**: Customizable templates mean that as industry standards or organizational practices evolve, audit templates can be readily adapted to reflect those changes. 13. **Enhanced Reporting**: Custom templates can be designed to capture data in a manner that aligns with organizational reporting needs, making post-audit analysis more streamlined. 14. **Improved Stakeholder Confidence**: Regularly scheduled and customized audits can boost confidence among stakeholders, be they customers, investors, or regulatory bodies, as they demonstrate a proactive approach to quality and compliance. 15. **Strategic Decision Making**: Data from these audits can be used by top management to make strategic decisions regarding process improvements, resource allocation, and overall business direction. 16. **Cultural Benefit**: The regularity and specificity of these audits can help in instilling a culture of quality and compliance within the organization, where employees are continuously mindful of standards and best practices. In summary, the ability to configure custom ISO QMS & compliance audit templates and schedule them for specific dates, departments, and auditors allows for a focused, efficient, and proactive approach to quality management. Such practices not only ensure compliance but also drive continuous improvement and operational excellence within the organization.

ISO, QMS, Compliance audit planning:

  • Configure custom ISO QMS & compliance audit templates and schedule QMS audits for specific dates, departments and auditors.
  • Use a table view to see which compliance audits have been planned, completed and missed, and those audits that are in need of review.
  • The audit schedule is broken down by department and activity audits, and can be further filtered by site.
  • Define the scope of the audit to be communicated to audit attendees in advance
  • Provides for ISO Audits that have to be conducted at planned intervals.
  • Professional reports with direct linking to CAP and non-conformity

ISO & Compliance audit reporting:

  • ISO QMS & Compliance Audits are automatically logged in an audit and non-conformance register.
  • Drill down into individual audit records to examine and update a range of audit information, including:
    • ISO & Compliance Audit scope
    • ISO & Compliance Audi report
    • Additional evidence
    • Attached images and documents
    • ISO & Compliance Non-conformances, root causes and corrective actions
    • Outcome (no issues found/further action required/opportunity for improvement)
    • Review date
    • Assigned tasks
**High-Level Compliance Audit Reporting Using the Zebsoft Platform** Compliance audits are intricate examinations that ensure a company's adherence to regulatory guidelines. When executed by competent persons and using robust platforms like Zebsoft, they offer clarity, precision, and transparency. Let’s discuss the high-level aspects of such reporting. 1. **Objective Overview**:  - **Purpose**: Each audit report begins by clearly defining its purpose. For compliance audits, the purpose usually revolves around ensuring adherence to specific regulations or standards.  - **Scope**: The scope determines the breadth and depth of the audit – which departments, processes, or time frames are under examination. 2. **Methodology**:  - Audit reports must describe the methods used to gather data and assess compliance. This might involve interviews, document reviews, and on-site inspections.  - The use of the Zebsoft platform ensures a consistent and systematic approach to data collection, backed by digital records that can be reviewed and verified. 3. **Findings**:  - **Non-Conformances**: These are specific instances where the audited entity failed to meet the required standards or regulations.  - **Opportunities for Improvement**: While not explicit violations, these are areas where the entity could better align with best practices or improve efficiency.  - On the Zebsoft platform, findings can be organized, categorized, and prioritized for easy review and action. 4. **Evidence**:  - Supporting evidence for each finding strengthens the audit's credibility. This could be in the form of documents, images, or digital records.  - Zebsoft’s audit report feature facilitates seamless attachment and referencing of evidence, making it easier for both auditors and the audited entity to understand the basis for each finding. 5. **Root Cause Analysis**:  - Beyond identifying non-conformances, a high-level audit delves into the root causes behind them. This helps in devising effective corrective actions.  - Using platforms like Zebsoft, auditors can track and document the process of root cause analysis, ensuring a thorough and systematic approach. 6. **Corrective Actions**:  - For each non-conformance or improvement opportunity, the report will suggest corrective actions.  - Zebsoft can log these actions, assign responsibility, set deadlines, and even monitor their implementation. 7. **Conclusion & Recommendations**:  - The report culminates in an overall assessment of the entity's compliance status.   - Recommendations might involve strategic changes, process overhauls, or further training. 8. **Review & Follow-up**:  - High-level audits often suggest a review date, ensuring that corrective actions have been implemented and are effective.  - Zebsoft’s platform offers features for setting reminders, scheduling follow-ups, and tracking the long-term impact of the audit. 9. **Stakeholder Involvement**:  - Engaging with all relevant stakeholders throughout the audit process is vital. Their insights, cooperation, and buy-in can be invaluable.  - With a platform like Zebsoft, stakeholders can have designated access, receive notifications, and even provide feedback directly within the system. In summary, when competent individuals conduct compliance audit reporting using a platform like Zebsoft, the resulting insights are both comprehensive and actionable. The fusion of expertise and technology ensures that companies not only understand their compliance status but also have the tools and guidance needed to enhance their operations and meet regulatory standards.

Raising CAPA & reporting ISO Non-Conformance:

  • Data within the audit CAPA and non-conformance register can be filtered, sorted and exported into CSV or Excel formats.
  • ISO & Compliance Non-conformance can be created within a planned audit
  • Direct raising of reactive non-conformance
  • Non-conformance fed by all users from feedback reporting
  • Checklist audits can be escalated to non-conformance
  • ISO & Compliance Non-conformances cannot be closed out until corrective actions (CAPA) are reviewed & effective

Comprehensive compliance auditing software with full corrective action control (CAPA) & quick audit with user defined templates ISO QMS Audit, GRC Audit, Compliance Audit, Product Audit.

A Perfect addition to any Quality Management System QMS

The purpose of ZEBSOFT Audit Management Software.

To create improvement in any area of a business it is essential to know that your activities are performing this how we manage risk and monitor the effectiveness of our processes and actions within our organisation. Audit Management Software provides a structured way to perform challenging and complex audits simply and efficiently.

The ZEBSOFT auditing platform plays a crucial role in making these improvements possible due to its multi-functional approach that seamlessly links basic checking to high-level compliance auditing and risk management. The platform offers fully customizable checklist forms, enhancing the efficiency and effectiveness of the audit process by allowing businesses to tailor the auditing procedures to their specific needs and requirements.

Moreover, ZEBSOFT applies background scoring to the checklist items, providing a data-driven evaluation of various aspects of the business over time. As audits are conducted and data is accumulated, the platform generates valuable insights into performance trends and areas that require improvement. This data-driven approach not only saves time but also facilitates a continuous improvement mindset.

The platform’s integrated data collection and analysis capabilities allow for comprehensive data gathering and analysis across different aspects of the business. By centralizing data from various sources and processes, ZEBSOFT provides a holistic view of the organization’s performance and potential risks, eliminating the need for manual data gathering and reconciliation.

ZEBSOFT’s high-level compliance auditing and risk management features play a crucial role in identifying and prioritizing potential risks to the business. By providing actionable insights into risk areas, the platform empowers management to proactively address vulnerabilities and allocate resources more effectively.

Customizable reporting and interactive dashboards further streamline the improvement process by facilitating quicker decision-making and better communication of findings. Auditors and management can access real-time information in a user-friendly format, promoting effective collaboration and communication among different departments and stakeholders.

The platform’s continuous improvement tracking capabilities enable businesses to measure the effectiveness of implemented changes over time. By tracking the progress of improvement initiatives, companies can make data-driven adjustments for ongoing enhancement.

Lastly, ZEBSOFT’s scalability and adaptability ensure it can handle new challenges as the organization grows or undergoes changes, providing long-term support for improvement efforts.

In summary, the ZEBSOFT auditing platform’s multi-functional approach empowers businesses to save time, optimize operations, address risks, and drive sustainable growth. By leveraging its customizable checklist forms, background scoring, integrated data analysis, risk assessment, customizable reporting, collaboration tools, continuous improvement tracking, and adaptability, ZEBSOFT enables organizations to conduct efficient and proactive audits, fostering a culture of continuous improvement and success.

The Benefits of ZEBSOFT Audit Management Software for quality management systems (QMS) and Integrated Management Systems (IMS)

Audit Management Software is the key to achieving more in the most efficient way. The current shift in management system auditing is that the internal audit process is now requiring Auditors to be proactive with risk management and to provide insights into achievement of compliance with regulation. Businesses are looking for solutions to make these tasks easier and more time-efficient to ensure the audit process is cost effective. The ability conduct the audit process quickly and effectively to a high standard will control and reduce the risk of non-compliance, spotting problems before they occur is the primary purpose of Audit Management Software and provides the ability to mitigate potential problems or issues, much quicker than outdated conventional approaches to auditing.

ZEBSOFT Audit Management Software supports all types of audits in your organisation and allows you to control how you would like that information delivered to and viewed by staff and management.

All aspects of auditing become automated for efficiency and productivity. You will create checklists that can be used on mobile devices to reduce the amount of paperwork associated with the checking process. Checklists can easily be printed off to ensure that your off-line record-keeping meets regulation.

ZEBSOST Auditing Management Software can provide tasking for the completion of audits at any time of the day or night and with any stipulated frequency. Audits can be scheduled across departments/sites. teams and multiples of individuals simultaneously using the same audit checklist without conflict.

ZEBSOST Auditing Management Software reminds the QMS/IMS auditors and auditees prior to the compliance audit, product audit, quality QMS audit . ZEBSOFT keeps auditors up to date automatically with email and system notifications. System auditors are provided full audit planning capabilities ensuring the audit program structure is maintained. The audit software allows your auditors to make amendments to the QMS auditing program to accommodate the fluidity required in the working environment as issues arise when the audit plan is in progress.

The ZEBSOST Audit Management software will never forget, the days of missing QMS audits will be gone from your organisation, audit results are available instantly to QMS auditors and mangers alike. QMS/IMS audit results can be compared over time so that you will achieve the best possible outcome from your auditing activities

ZEBSOST Auditing Management software is linked to tasks at all levels this ensures that not only the results of the auditing are communicated but also that the outputs from the QMS audit process are managed effectively and reported back to the auditor, stating the necessary actions required to remain compliant. The auditing software will track and notify when these tasks have been completed.

ZEBSOST QMS/IMS Auditing Management software will take your auditing to new levels, checklist audits will feed to audit tasks, product audits will feed compliance audits, the QMS audit results will feed to CAPA, non conformity and continuous improvement.

Auditing using checklists and formal audit programs is important to businesses for several reasons:

1. Consistency: Checklists and formal audit programs provide a structured and standardized approach to auditing. They ensure that all relevant areas are examined consistently, reducing the risk of oversight or inconsistency in the audit process.

2. Compliance: Many industries have specific regulatory requirements that businesses must adhere to. Using checklists and formal audit programs helps ensure that the business is compliant with these regulations and industry standards.

3. Comprehensive coverage: Auditing checklists and programs are designed to cover all critical aspects of a business’s operations, finances, and processes. This comprehensive coverage ensures that no important area is overlooked during the audit.

4. Efficiency: Having predefined checklists and audit programs streamlines the auditing process. It saves time by providing auditors with a clear roadmap of what needs to be assessed, making the process more efficient.

5. Documentation: Checklists and formal audit programs serve as documentation of the audit process. They provide evidence of the audit’s scope, procedures, and findings, which is essential for internal use, external compliance, and future reference.

6. Risk identification and mitigation: Auditing using checklists and formal programs allows businesses to identify potential risks and weaknesses in their processes and controls. This early identification enables the business to take corrective actions to mitigate these risks before they escalate into significant issues.

7. Objective assessment: Checklists and formal audit programs promote objectivity in the audit process. Auditors follow predefined criteria, reducing the influence of personal biases and ensuring a fair and unbiased evaluation of the business’s performance.

8. Continuous improvement: Regular audits with checklists and formal programs help businesses monitor their performance over time. The findings can be used to implement continuous improvement initiatives, enhancing the overall efficiency and effectiveness of the organization.

9. Accountability and transparency: The use of checklists and formal audit programs creates a transparent and accountable audit process. It allows stakeholders, including management, investors, and regulatory authorities, to understand the audit scope and the basis for the conclusions reached.

Using checklists and formal audit programs enhances the credibility of the audit process, provides valuable insights into the business’s operations, and assists in maintaining compliance and good governance practices.

 ISO Standards

Accreditation Bodies

Zebra Software Limited

  • Head office: Booths Hall, Booths Park, Knutsford, Cheshire, WA16 8GS. 
  • Registered office: Riverside, Mountbatten Way, Congleton CW12 1DY, United Kingdom
  • Registered in England and Wales 11901161
  • ICO number A8778081