copyright © 2016 s4bt srl s4bt.it/en/pragma€¦ · the shortest route: pragma® is designed on...

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Copyright © 2016 S4BT Srl

s4bt.it/en/pragma

http://www.s4bt.it/en/pragma

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Non-Compliance Process

Non Compliance is in fact an anomaly, an error detected in a product, a service

or a process. They are generally identified during the performance of activities or

to a lesser extent, through a complaint from the market, external audits, or simply

through internal audits. It is therefore clear that the management of non-

compliance is a fundamental process for the Quality System of a Company.

Regulatory standards governing the Quality System - including the recent ISO 9001:

2015 - require that all activities related to the Non-Compliance process are

documented and recorded. This is especially useful for checking what actions have

been taken to resolve the anomalies in the process. The quality, safety and

effectiveness of the final products also depend on this. When a deviation occurs, it

is important, therefore, to resolve it in a timely manner and in accordance with

relevant regulations.

Why is it important to computerise the Non Compliance process

with dedicated software

Computerising such a strategic process as Non Compliance with dedicated system

helps companies:

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1. Monitor and track anomalies (numerosity, areas, departments, products

involved, etc.) providing details on the weaknesses, the trend of deviations

observed, non-quality costs

2. Ensure that flows and internal procedures are faithfully adhered to; the

system guides users in carrying out their tasks (for example using a checklist)

3. Process and track the Action Plan required to resolve anomalies

4. Track and monitor the impact of Non Compliance on their products

5. Create a strong link between processes: a dedicated system, such as

PRAGMA®, allows a CAPA process to be opened directly from an

incidence of non-compliance or from a complaint from the market, for

example.

6. Integrate information from other company systems (ERP, MES, etc.)

This considerably increases compliance with regulatory standards while reducing

errors and wasted time.

PRAGMA® allows Non Compliance to be managed from the time it is opened until

its closure, be it positive or negative. It also allows full management of alarms,

sensors and all objects involved in the Non compliance.

Companies that have computerised the Audit Process with PRAGMA® have

improved their performance for at least 6 different reasons:


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The shortest route: 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.

What the FDA wants: A system like PRAGMA® provides the security of working in full

compliance with FDA 21 CFR Part 11 in terms of audit trail, electronic records and

signatures.

Information at the centre: PRAGMA® stores all the information about the CAPA and

related processes in a single db. The documents and information are thus shared

between departments, but accessible only to those who have the necessary

permissions.

Accurate analysis at all times: A dedicated system such as PRAGMA® tracks all

types of activities within the process. Nothing can get out of control. The analysis

and reporting tools also provide full transparency on activities and relevant

information. At any time you can check the status of the job and extract key

information. This feature proves particularly useful during inspections.

Web-Based Platform: PRAGMA® is easily implemented in any type of business

organisation. 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 like Complaints, Document Management or Training. All this

gives the Company Quality System an even more holistic approach.


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How PRAGMA® computerises the Non Compliance process

On the basis of "best practices" in the sector, PRAGMA® computerises the Non

Compliance process in 5 phases:

1. Opening a Non Compliance

2. Investigation

3. Investigation result

4. Follow up

5. Conclusion

Each user involved in the system can access the process of interest in two

different ways:

A. Via a link in the email that PRAGMA® sends automatically

B. Direct access through the Filters tool. In this case you can narrow the field of

view of all relevant processes by selecting specific variables: the process

subject, tasks, attachments, keywords, etc.

Each employee involved accesses with their ID and password, in complete

respect of the FDA provisions on Data Integrity.


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1. Opening

At this stage the user will enter into the process all the information necessary to

provide a complete picture of the anomaly detected: the system will help in the

compilation, suggesting details on the event description, date and product / batch

involved. Thanks to the full integration of the platform with other business systems,

PRAGMA® is connected directly with the company's ERP. Therefore it ensures that

the information on the products and batches are extracted from up to date

information.

For this specific task, the system does not allow you to enter the same references

for two different products / batches involved in the deviation, thus eliminating any

possibility of making mistakes.


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To provide comprehensive and detailed evidence, the user opens a Non

Compliance and can then attach images, photos and documents to the process.

The files will then be visible to all users involved. This capability helps to strengthen

communication and sharing between departments and to track all information

easily.

When the Non Compliance is opened, the user can record in detail any immediate

action taken to stem the problem related to the fault, via the "Direct Actions"

function.

The tree menu present on the process page summarises all stages of the flow and

guides the user in carrying out their tasks at specific stages.

PRAGMA® thus makes sure that resources and departments respect the structure

of flows and internal company procedures.

When all the required fields have been completed, the user clicks "Next State". To move

to the next phase of the flow it is therefore necessary that all signatories involved in the

workflow approve it.

Just as it does with paper management, the Non Compliance process in

PRAGMA® involves multiple departments and resources that are called on to

approve it. In 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 the structure of the process and

internal procedures.

In PRAGMA® signing means entering your system login details and password.

PRAGMA® is designed with the aim of ensuring that each


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process evolves smoothly and naturally, even in the absence of the persons

involved. In the event that, for example, a person is absent or unable to sign their

approval, the system automatically involves all those who have been temporarily

authorised to sign, thanks to the "Proxy Management" function. This provides

Process Managers with the peace of mind that all work tasks are carried out in

exactly the manner in which they were planned and without interruption.

2. Investigation

The investigation is a crucial point in the management of Non Compliance. It is in

this stage that an organisation that works in compliance analyses in depth the

origin of the deviation. It is important, then, that the investigations follow precise

guidelines.

PRAGMA® guides users through a powerful control tool: the checklist, which allows

you to direct and standardise the analysis process. In the course of the

investigation, as well as in all the other stages, the user can share documents using

the Attachments Module by uploading the extracted file system directly from a

folder on your computer or the corporate network. The platform accepts all formats

(word, excel, pdf, video, jpeg, mp3, etc.). Once the investigation phase is

completed, the user affixes a signature by typing in their password, according to

FDA 21 CFR Part 11. Thus, the process goes to the next state.

Once again in this phase, transition to the next takes place


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only if all parties involved have confirmed their approval. Otherwise, the process

automatically returns to the previous stage. PRAGMA® track all activities carried

out within the process, therefore, it provides complete information on the "history"

of the process in a transparent manner.

3. Investigation results

At this stage the user records detailed information on the outcome of the

investigation, the root causes and impacts.

In response to a special relationship of non-compliance in this stage, the user has

two choices:

1. Initiate corrective and preventive actions: PRAGMA® opens a CAPA

process originating from the Non compliance

2. Assign tasks using the PRAGMA® Tasks module


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A user can use the Tasks Module to assign specific tasks (preparatory to deviation

management) to other company employees. PRAGMA® tracks and monitors the

progress of tasks, details of which are fully accessible to all roles involved in the flow.

Thus, in a nutshell, PRAGMA® connects different departments virtually,

empowering communication and information exchange. From the activity plan set

up in the Complaints Process, PRAGMA® can automatically generate a GANTT in

Microsoft Project format.

4. Follow Up

At this stage the process managers carry out follow up activities, enhancing the non

compliance process with additional comments and updated information. At this


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point in the flow, moreover, all those responsible for individual tasks record their

completion indicating the effective start and end date. In the event that 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 that highlight the

grounds for the delay.

In this stage too, all the resources involved have to confirm their approval to

advance to the next step.

5. Conclusion

Based on the analysis and the actions taken, the user records whether non-

compliance is considered acceptable or not. In this stage, PRAGMA® provides the

option of entering additional information (notes) visible to all resources involved in

the flow.


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When this round has been signed, the process is considered concluded.

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.

Process file generation is a particularly useful feature during audits.


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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, extracting all the information

recorded in the process (as shown below) for a more in-depth analysis and

performance monitoring.


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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 effective 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

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.


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