Why Do We Need to Automate Deviation Management in Pharma?

Challenges with manual paper-based deviation management

• Manual Deviation Management involves reports, Excel spreadsheets and Microsoft Word documents for reporting and tracking the adverse events which include deviations, defects, laboratory incidents and issues with supplied material.

• Daily meetings with the representatives from quality, compliance, engineering, logistics and production were held to review and determine all adverse events.
• Attendees will not have any information regarding the incident before the meeting, Before beginning any resolution discussion a Lot of time is spent on bringing them together and informing them about the incident. In general, issues occurred before 2-3 days are discussed in the meetings. issues with In 1-2 days before the meeting will not be known to many and before beginning any corrective action, multiple meetings were needed to discuss the issue.
• Lack of data visibility among quality and regulatory team members and the circulation of multiple disconnected tracking sheets impacts the employees by overloading emails.
• Information on events and deviations will not reach the correct individuals through email channels. Lower priority or unnecessary notifications will reach the executive team, making it difficult to track critical CAPA items.
• It is very difficult to track action plans and assign tasks for deviation management and change control. Escalations and follow-ups for corrective actions will be extremely difficult.
• In total, a manual system leads to inconsistent quality management and ineffective resource utilization.

Benefits with an automated deviation management system

• As all attendees will be aware of the events to be addressed before the meeting, daily meeting time will be greatly reduced.
• The number of participants will also be reduced because only staff from affected departments were required to attend
• As all events and detailed information are sent to relevant departments before meetings, immediate resolution can be obtained for the majority of the adverse events and appropriate CAPAs could be assigned to avoid recurrence.
• onsite users can be fully engaged in working in the system without much need for administrative support. You can schedule meetings only for critical events in which additional discussion is needed
• Automated deviation management will initiate and process all the corrective actions across All the Operations and dispositions.

INSTANT INFORMATION AND STREAMLINED PROCESSING FOR EVERY INCIDENT

Status details of all defects were available at the click of a button at every single minute, ensuring every issue could be addressed quickly and easily. processing of reported defects and corrective actions are tracked by automatically sending reminders to staff advising of pending tasks and auto-escalating any late items to the appropriate personnel.

QUALITY RESOURCES SAVED AND TRANSFERRED TO MORE VALUE-ADDED ACTIVITIES

In addition to the Significant time saving, need for staff for administrative activities like scheduling, communications, locating lost documents and duplicate tasks to minimize work personnel hours. These resources can be moved into more value-added activities.

AUDIT MANAGEMENT

Furthermore, The integration of Audit Management to the deviation management system streamlines preparation for regulatory audits.

Regulatory audit preparation time was reduced significantly and overtime was reduced (and in some cases eliminated) because the built-in document handling, data collection, task escalation and notification features ensure that the Defect Reports and their related CAPAs were closed on Schedule.

SUPPLIER QUALITY MANAGEMENT

This system can be expanded by integrating supplier defects management. When raw materials (supplier) or packaging (sub-contractor) defects are entered into the System, supplier or sub-contractor details are automatically pulled into the Quality management system from the ERP.

Based on the defect type, tasks are created automatically to follow-up on each reported defect.

ENVIRONMENTAL HEALTH & SAFETY COMPLIANCE

Chemical or pharmaceutical defects are automatically evaluated to measure their impact on EH&S and material disposal requirements. Tasks are automatically generated to ensure these impacts are minimized as well as regulatory requirements are met.

Quality Management and Regulatory Compliance System helps FDA regulated businesses to meet their requirements in a fast and easier way.

Solution

An automated system can capture an event and identify whether it is a problem and assess any associated risks, investigate to the required level, capture and track all CAPAs, and review effectiveness.

This helps to resolve issues quickly and prevent them from happening again ensuring an organization is fully compliant with industry and regulatory requirements.

Automatically identify and track proactive events through an efficient change management workflow including an effectiveness check after implementing the action item.

Manage change control, CAPA, and deviation activities with automated quality management through standard processes and real-time visibility. You can pro-actively identify the required action to ensure smooth operations and continuous compliance.

Every incident is connected and changes can be managed easily online

Now individuals can have their list of tasks for changes, CAPAs, investigations, etc.

Enhanced visibility makes it easier to see the status of the issues such as what work has been done and what items still require completion.

You can link all the data obtained through investigation to the incident via attachments. The software replaces offline investigations and tracking.
Consolidated data and all other insights are at your fingertips.

Improved communication and automated task assignments

Reduce lag time between the notifications and resolution activities, providing the ability to see all open changes and their associated tasks.

The software has in-built tools that enable electronic signatures and automate regulatory record keeping, helps to conduct risk, compliance and safety monitoring.

Automated systems increase efficiency and bring costs down

Major cost savings include

• Increased accuracy and efficiency of event recording and reporting
• Automatic routing and escalation
• Reduced event time-to-resolution
• Detailed trending and reporting
• Improved access to records and information
• Increased management oversight of compliance risk

build consistent, efficient processes to reduce quality issues, increase productivity and meet industry and regulatory requirements visibility of action items and tasks has been increased immensely that must be completed promptly on time.