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2 Complaints Complaints include the set of all the reports of discrepancies and irregularities from the market. For a Company with a solid approach to quality and compliance, effectively managing complaints is equivalent to automatically increasing customer satisfaction, protecting the reputation of the brand, ensuring compliance with industry standards and implementing Continuous Improvement. The complaints process is not limited to the simple recording of anomalies, but embraces the set of activities designed to analyse the causes and to activate a structured action plan. Complaints are therefore closely related to other fundamentals of quality processes such as CAPA (corrective action preventive action), Changes and Non-Compliance. Why is it important to computerise the CAPA process with dedicated software Complaints represent a critical process that is complex in a certain sense: discrepancy reports - for example - can come from different sources (phone, , company, sales department, etc.). Also anomalies of different types require many specific Action Plans. That's why "hard copy" management of the entire flow can be laborious and inefficient. 2

3 This is even more true for multi-plant, multinational and multilingual companies. The challenge for Companies, especially those who work in regulated markets, is to optimise the complaints process to effectively correct the discrepancy in minimal time and respond to market signals. Specific complaints software, such as PRAGMA, however, helps companies to achieve this, for at least 7 different reasons: Perfect compliance: each complaint received is properly recorded, evaluated and corrected. The system tracks and documents all the Actions, according to the most stringent reference standards. A system like PRAGMA also ensures full compliance with FDA 21 CFR Part 11 in terms of audit trails, electronic records and signatures. Standardisation and central positioning of information: a dedicated software like PRAGMA standardises internal flows, encouraging collaboration between departments and the exchange of data and information. PRAGMA is designed on the basis of the relevant legislation and "best practices " in the sector. It is therefore able to manage companies in the most effective way possible. Faster surveys, risk minimisation: the information is centralised. Everything works exactly as planned. All the resources involved in the process are "guided" by the system so they know exactly what to do 3

4 and when to do it. The possibility of errors and closing times of a complaint are reduced to a minimum. Complete control over the evolution of the resulting actions: PRAGMA constantly keeps track of the actions taken following the Complaint, during their life cycle Easier Audit: the analysis and reporting tools provide comprehensive information on the activities and documentation. At any time it is possible to check the progress and extract key information on the Complaints Process. This feature proves particularly useful during inspections. Web-Based Platform: PRAGMA is easily implemented in any type of business organization. Precisely because it is a web platform, each employee involved in the process can access it from anywhere at any time. Valuable additions: PRAGMA can be integrated with other systems and with other Business Processes. How PRAGMA computerises the Complaints Process On the basis of best practices in the industry, PRAGMA computerises the Claims Process in six stages: 4

5 1. Opening a Complaint 2. Pre-assessment 3. investigation results 4. Follow Up 5. Assessment of the impact of the complaint (conclusion) 6. Complaint closure 1. Opening a Complaint As a result of the prior configuration of permissions and signatures, PRAGMA automatically select users to be involved in the process (based on role and area of competence) and sends them an alert via mail. Each user can get involved in the process of interest via the link in the mail that PRAGMA automatically sends or via the Filters tool directly on the platform (process object, tasks, attachments, keywords, etc.). Each employee accesses with their own ID and password, in full respect of the FDA principles regarding Data Integrity. Immediately after creating a new process, the user will see a screen like the one shown below. PRAGMA guides the user in every step of the process, 5

6 ensuring that certain activities can only be carried out by authorised resources. This ensures full compliance with internal procedures and the flow structure. To open a complaint, the user enters all the information needed to carry out the investigation, namely: - Country - Production line and family of products involved - Date on which the complaint was received - Sender / Claimant - Department that has received the complaint - Any samples received - Mode of receipt - Notes 6

7 Once registered in the system, all information will be fully shared between the various departments involved. All this allows PRAGMA to create a mapped sequence of information that is able to guide the user step by step and eliminate the possibility of errors or loss of information. Thanks to the full integration of the platform with other business systems, PRAGMA is connected directly with the company's ERP. When you open a complaint, therefore, PRAGMA ensures that the product information is extracted from ERP data that is always up to date. When all required fields are complete, the user clicks "Next State". Thus, the process moves to the next section. Just as with "paper management", the PRAGMA Complaints process involves multiple departments and resources, which must confirm their approval with a signature (in this case typing their system password). With PRAGMA signatures may be organised by levels. That is to say that the signatories of "second level" cannot sign unless those of the first level have already done so. This ensures compliance with corporate directives. To move to the next phase of the flow it is therefore necessary that all signatories involved in the workflow approve it. Otherwise it is returned to the previous stage to make the necessary corrections. In this case PRAGMA requires users who refuse to sign to record a short justification in a specific notes field. A particularly interesting feature is the ability to create proxies. In the event that a person is absent or unable to append their approval, 7

8 the system automatically involves all who have been temporarily authorised to sign. In doing so PRAGMA ensures that the process continues to evolve as planned, regardless of the individual involved. 2. Pre-assessment The report of a Complaint may come from different departments (customer care, sales, etc.), while the pre-assessment is a process step that requires the technical intervention of the Quality Assurance department specialising in Complaint Management. In this phase, the "complaints experts" attributed a specific category (based on an internal classification) and the priority and actions to be taken to the reported complaint (pharmaco-vigilance communication, investigation, etc.) 8

9 In this stage it is also necessary to specify whether there are other complaints of the same nature related to the same batch or if there are similar incidents of noncompliance already highlighted in the past. 3. Investigation results Following the pre-assessment, the Quality Assurance complaints department performs the necessary in-depth analysis "in the field", almost always involving Production or the Warehouse. Once the investigation has been concluded, the users involved record in the system all the considerations and the steps needed to close the complaint (for example: replace a car, start new operator training, etc.). The Manager defines the Action Plan attached to the Complaint, based on the scale of action required, in one of two ways: 1. He/she initiates corrective and preventive actions: PRAGMA automatically opens a CAPA process, originating from the complaint process. 2. He/she assigns tasks to other users using the PRAGMA Tasks module The Tasks module is the platform-specific feature that allows a user to assign certain tasks to others to help resolve and eliminate the non-compliance. PRAGMA tracks the assigning and performing of tasks. In this way everyone involved is always informed about the status of the job. 9

10 From the activity plan set up in the Complaints Process, PRAGMA can automatically generate a Microsoft Project GANTT. In this and all other phases, users also have the option of using the Attachments Module, to add specific documents to the process in various formats (Word, excel, pdf, video, jpeg, etc.), directly from one of their computer folders. 10

11 All users involved in a process can view the documents uploaded to the system. PRAGMA thus contributes considerably to: A. Streamlining and speeding up the exchange of information between departments and different business roles B. Tracking and recording useful information including during inspections. In the evaluation phase, users add specific data useful for measuring the impact of the complaint on production and - possibly - on the company's business. The date of manufacture, the size and number of the batch number, the number of defective units and the incidence rates of non-compliance on the batch are some examples of important information for the analysis. 11

12 4. Follow Up In this specific phase, PRAGMA helps the resources involved in monitoring the activities necessary to close the complaint reported by the market. They can also display the details of any CAPA generated from the complaint. Thus the user will have the overall picture of all the events resulting from the alert from the market right in front of him/her. In the Follow Up, all those responsible for individual tasks will record their completion, indicating the effective start and end date. If the actual closing date is later than planned, PRAGMA forces the user to provide reasons in the form of a brief description and, if necessary, specific documents highlighting the grounds for the delay. 12

13 5. Assessment (conclusion) At this point in the flow, the responsible employee enters the final result of the assessment in the system, highlights the possible withdrawal of indicated batches and confirms or doesn't confirm the pre-assessment. Here also PRAGMA "guides" the user eliminating the possibilities of human error. 6. Complaint closure To close the complaint with PRAGMA, feedback must be sent to the person making the complaint, thus ensuring that the customer always receives feedback about the inconsistency reported. 13

14 At this stage of the process, users involved can enter additional notes, attachments, suggestions and planned activities (for example to provide evidence of completion of the services or the resolution of a problem). File and Report PRAGMA auto-generates a file corresponding to each process, a protected pdf document summarising all flow information, updated in real time and including any attachments. All authorised users can open, check, save and print the document if necessary. When a user instructs the system to generate the file, they can choose whether or not to include the signatures of all the resources involved in the process. File generation of Processes is a particularly useful feature in the inspection stage. Companies using PRAGMA can choose to customise the file with the graphics, fonts and colours of their brand. Alternatively, they can use standard formats. The language in which PRAGMA generates the file is the one selected when the process was opened. PRAGMA allows custom reports to be made, 14

15 extracting all the information recorded in the process (as shown below) for a more in-depth analysis and performance monitoring. To create a custom report, the user simply has to drag all the available variables into the left column and cross them in the most useful way. The output of the Report can take seven different forms: 1. List (processes, tasks, etc.) 2. Bar chart 3. Stack bar chart 4. Pie chart 15

16 5. Line graph 6. Report in Excel format 7. Report in PDF format (Create PDF) In addition to custom reports, you can also use the Default Reports, namely the pre-configured templates that help users set up a particularly advanced analysis. These include the possibility of extracting information on the Audit Trail. Each user can save reports they create and use them later as templates. With the necessary permissions, you can also share the latter with other users. 16