Comment pouvez-vous éviter les erreurs d’intégrité et de sécurité des données dans GMP?

1. Always trace data back to its source and ensure it's clear, whether handwritten or digital. 2. Record data as events unfold. Immediate documentation reduces errors. 3. Trust original records most and always double-check for precision. 4. Maintain uniform methods and ensure no gaps in data. 5. Securely store data where it remains both protected and easily accessible. 6. Stick to trusted systems like 21 CFR Part 11 and eQMS. 7. Show teams the real consequences of data mistakes, from patient risks to business losses. 8. Every data point matters to someone's health. Keep that in mind.

Data integrity controls can be established at three levels: 1. Organizational level by implementing - Quality Culture - Code of ethics and policies - Training - Quality Management system 2. Technical controls by implementing - Access control - Password Management - Roles and privileges - Validation of computerized systems - Desktop policy controls - Data backup, restoration 3. Procedural controls by implementing - Change Management - Periodic review - System Audit trail review - Disaster and Business continuity Management programs - Self inspection programs focused on Data integrity aspects

Have 21 cfr part 11 compliant digital platforms. This a design level approach towards ALCOA Plus compliance. Data governance to pick up non compliance and trainings to bring cultural change.

The industry who are dealing with highly regulated market is much aware about ALCOA+. Most of the companies have developed the data integrity cell/team. Per my experience while dealing with all such cases and delivered so many training sessions on data integrity, the foremost thing to overcome the data integrity issues and sustainable in maintaining the compliance is; "Inculcating the culture of honesty, transparency and freedom of discussion to each employee with basic understanding of ALCOA+" This cultural shift in any organization can help to transform them from legacy system to the new and advance system. No company can be rid of from DI, unless each individual is trustworthy and transparent towards each one and their work. Thanks!!

When it comes to maintaining data integrity in GMP environment, it's crucial to follow best practices & implement robust measures. It is important to keep on validating every steps implemented at a periodic timeframe. This will enable to track down any possible vulnerabilities and gaps in data security and controls. Establish a clear policies and procedures for data management, including data entry, storage acess and retentionretention with clear guidelines of roles and responsibilities of employees.

Promote a Culture of Integrity. Implement Quality Control Measures. Create an Audit Trail. Develop Process Maps for All Critical Data. Eliminate Known Security Vulnerabilities. Follow a Software Development Lifecycle. Validate Your Computer Systems. Implement Error Detection Software.

1. Build and Impose the Quality Culture in every working personnel 2. Software controls … 21 CFR part 11., eQMS ., eBPR and etc 3.Practical training sessions, if violating data integrity and impact on patients safety, loosing the trusteeship and theory by bussiness

To ensure data integrity and security in GMP, establish a culture of compliance with strong leadership commitment, regular employee training, open communication, and a focus on continuous improvement. Implement a robust data governance system with clear policies, defined roles, risk management, and technology support. Foster accountability, develop an incident response plan, and encourage reporting. This holistic approach safeguards pharmaceutical product quality and safety.

Integerate data integrity and data governance policy in to the companywide quality management system; define data life cycle management and the level of risks involved and required control from data acquisition, analysis, reporting, archiving, transfer, and disposal. Establish regular review of data integrity throughout the data lifecycle. Advocates for quality culture, reporting quality issues without fear!

Regular internal audits and inspection Access controls, audit trails, documented process, training and awareness Build a culture of transparency and trust It needs a comprehensive and top down approach.

Build this into your design requirements. The earlier in your process you consider privacy and security, the more likely you are to get it right.

In addition to ISO 9001 as a means of managing quality that works well with GMP, ISO/IEC 27001 provides the requirements for an information security management system (ISMS) and can really help to address the data integrity (and other) aspects of the GMP.

While we have systems in place, there's always room to improve. By tightening our data governance - clarifying roles, setting stricter standards, and tracking our data's journey - we can better align with both our organizational goals and GMP requirements. It's a step towards not just managing but excelling in data integrity.

Implementing a data governance system is a crucial step in controlling data integrity issues. Here are further suggestions. (1)Assign responsibility for data integrity to specific individuals or teams. (2)Create and enforce data quality and security standards.(3)Maintain comprehensive data documentation to track changes and ensure transparency. (4) Conduct routine audits to identify and rectify data integrity issues.(5)Provide ongoing data governance training to staff. (6) Develop SOP/protocols for addressing data breaches or integrity violations. (7)Define data retention and disposal policies. (8) Continuously monitor and adapt to changing regulations.

Implement a Data Governance System A data governance system is crucial for maintaining the integrity and security of data within an organization. It establishes clear guidelines for data management, including data ownership, accountability, and usage policies. By defining roles and responsibilities, organizations can ensure that data is collected, processed, and stored consistently and securely. Regular audits and assessments of data processes can help identify areas for improvement, ensuring compliance with regulatory requirements and enhancing overall data integrity. These practices are integral to maintaining robust data integrity and security in GMP environments, fostering a culture of accountability and compliance.

In my experience, the data governance system is not a one-size-fits-all approach, but a customized and flexible framework. It should be tailored to the specific characteristics and challenges of the organization, especially on complexity, diversity, and maturity of the data environment. It should be regularly reviewed and updated to reflect the changing needs and expectations of the organization, the customers, the regulators, and the industry.

To maintain software and hardware performance and reliability, use validated, secure systems that undergo regular maintenance, updates, and testing. Implement a documented change control process to manage modifications and assess their impact on data integrity and security. Periodic reviews are essential to evaluate software and hardware effectiveness. For robust data integrity and security in GMP settings, comply with regulations (FDA, EMA, PIC/S, GAMP). This ensures adherence to standards and best practices, assuring that software and hardware meet requirements for safeguarding data integrity and security.

Validation alone isn't sufficient for data integrity; maintenance and security are equally vital. Maintenance ensures systems remain functional and up-to-date, while security safeguards against data breaches. Neglecting either can compromise data integrity and compliance.

Utilizing validated and secure systems ensure that software performs as intended and complies with regulatory standards. Security measures such as encryption, access controls, and regular software updates are vital for protecting data from unauthorized access and breaches. Organizations should conduct regular risk assessments and vulnerability testing to identify potential weaknesses in their systems. Selecting reputable vendors and ensuring compliance with industry standards can further enhance data security and integrity. These practices are integral to maintaining robust data integrity and security in GMP environments, fostering a culture of accountability and compliance.

Validated software are a robust tool for management of various aspects of quality systems. For GMP operations, many of the ALCOA+ principles can be incorporated into the software (i.e. requiring verifier signatures, notifying of late entries, etc). An audit trail is another nearly universal aspect of a well managed data integrity program as all attempts to access and/or manipulate the data are strictly controlled and documented.

Take advantage of the features of your validated software to get rid of non-validated and unsecured systems, like spreadsheets.

To maintain data integrity and security, train and monitor staff closely, emphasizing accurate data documentation, traceability, and transparency while discouraging harmful practices. Equipping staff with necessary skills and tools is crucial. Regular monitoring and auditing detect and correct errors and violations. Integrating strong data governance aligns with industry best practices, reinforcing the organization's commitment to data integrity and security. I have seen that when the context is fully explained to the employees, there is greater ownership and compliance to the system compared with the checks employed to catch errors. This needs a culture change.

I agreed. Workforce personnel should have sound knowledge on data integrity principles. Workforce is the main contributing factor for data integrity issues.

Training and continuous monitoring of staff play a vital role in maintaining data integrity. Employees must understand the importance of data accuracy, security protocols, and their specific responsibilities regarding data management. Regular training sessions, workshops, and assessments can reinforce best practices and keep staff updated on regulatory changes. Additionally, monitoring employee performance and compliance with data handling procedures can help identify and address potential weaknesses or knowledge gaps. These practices are integral to maintaining robust data integrity and security in GMP environments, fostering a culture of accountability and compliance.

When your staff is dealing with data from multiple products that may be at different levels of maturity, I have that data aids based on process documentation helps to keep them centered on the correct data. The aids do have to be revised with the process documentation in order to keep their effectiveness.

Training and monitoring alone may not suffice due to human errors, malicious intent, evolving threats, system complexity, and inadequate tools. To enhance control, add robust cybersecurity, regular audits, a data integrity culture, ongoing staff education, and state-of-the-art tools are also essential to control data integrity breaches.

One thing I have is that human error is unavoidable it may be human alone or man+machine combo, either all the personnel should be encouraged to report any sort of incident let it may have product impact or not and i strongly believe the individual should not be blamed for the error rather a sound system or method should be in place to avoid recurring. Investigations should be thoroughly done to identify systemic or probable root cause and the same should not be repeated.

It is important to record and report issues or incidents clearly and completely. Use of electronic signatures for changes ensure there is full traceability. This aids in identifying root causes and implementing corrective actions, reducing future errors and costs, and enhancing data integrity and security in a GMP environment. It is also necessary to ensure data governance includes reporting procedures, staff training, and monitoring to maintain compliance with data integrity and security standards.

Document and Report Any Issues Thorough documentation is essential for tracking data integrity and security issues. Organizations should establish a clear process for reporting any discrepancies, errors, or potential breaches. This includes documenting the nature of the issue, its impact, and the corrective actions taken. Such records not only facilitate regulatory compliance but also contribute to continuous improvement efforts. A transparent reporting culture encourages staff to identify and address problems promptly, reducing the risk of significant data integrity issues. These practices are integral to maintaining robust data integrity and security in GMP environments, fostering a culture of accountability and compliance.

Implement robust access controls to limit unauthorized system access. Use validated, secure electronic systems for data entry and storage, ensuring audit trails are in place. Conduct regular training for employee on data handling and security protocols. Establish SOPs for data review, backup, and recovery, and enforce strict policies on password protection. Regularly audit systems to identify potential gaps. Maintain documentation controls, ensuring data is accurate, complete, and consistent throughout its lifecycle, minimizing the risk of manipulation or loss.

Summing it up: • GMP is both a regulatory requirement and a competitive advantage. It showcases an organization's dedication to quality and safety, earning trust and satisfaction from customers and stakeholders. • GMP is a dynamic field, evolving with scientific, technological, and industry advancements. Staying updated on the latest trends and adopting relevant best practices is important for its ongoing relevance. • GMP is integrated with various aspects of the organization, including strategy, culture, processes, and systems. It's interconnected and influences and is influenced by these factors.