Copyright © 2016 S4BT Srl s4bt.it/en/pragma · s4bt.it/en/pragma Web-Based Platform: PRAGMA® is easily implemented in any type of business organisation. Precisely because it is

1

Copyright © 2016 S4BT Srl

s4bt.it/en/pragma

http://www.s4bt.it/pragma

2


s4bt.it/en/pragma

Why CAPA

The CAPA flows from non-compliance, by an anomaly found within the work

process. Thus, using a CAPA process, a company not only prepares an Action

Plan, but determines, implements, and also controls the effectiveness of an

solution identified. In essence, this process allows the company's Quality System

to "self-correct" and perfect itself.

Precisely for this reason, the CAPA is a basic flow within an organisation that works

in quality. Through the proper management of preventive and corrective actions

in fact, the company achieved at least 5 significant advantages:

1. Certainty that non-compliance will be resolved as effectively as possible

2. More efficient working processes, thanks to a considerable reduction in

the number of errors and wastage

3. Greater satisfaction of end consumers, due to a considerable decrease

in the number of complaints from the market

4. Full implementation of the principles of continuous improvement

5. Satisfaction of regulatory requirements

All this generates more efficient performance, with consequent saving of

resources and time.


3


s4bt.it/en/pragma

Why is it important to digitize the CAPA process with

dedicated software

Companies that computerised this flow found at least six advantages:

The best way: a software solution such as 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

and 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 actually authorised.

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.


4


s4bt.it/en/pragma

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. Direct link with Risk Management, Non-

compliance, Management Documentation, Complaints or Training are

just some of the possible examples of integration. All this gives the

Company Quality System an even more holistic approach.

How PRAGMA® digitizes the CAPA Process

CAPA is a process that can involve many employees at various "levels". It is

important, then, that even the business roles that (by their nature) do not have

an overall view, understand to what extent each activity linked to the CAPA

process is a first step to solving unexpected anomalies. PRAGMA® helps

companies create this overview, by making it easier to share data and

information.

When the system is configured, the Process Manager can attribute the signing of a CAPA

to a specific person (identified by name) or a role.


5


s4bt.it/en/pragma

On the basis of best practices in the industry, PRAGMA®

computerises the CAPA process in three phases:

1. Definition of CAPA

2. Follow up (monitoring)

3. Evaluation of effectiveness

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.

When they access PRAGMA®, users find all the information to be viewed and

any documents to be signed on their own home page. Each resource accesses

with their own ID and password, in full respect of the principles of Data Integrity.

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 it is possible to narrow

down the field of competence of all the processes using certain

parameters, such as: job object, tasks, attachments, keywords, etc.


6


s4bt.it/en/pragma

1. Definition

Definition is the first step of the process. At this stage those who open a CAPA

collect and record information on the action plan, specifying the impact that

this will have on different business areas.

With PRAGMA® a CAPA process can be manually created on the system or

automatically by another process type.

When a new workflow is opened, the user will see a screen like this:


7


s4bt.it/en/pragma

The tree menu in the left column provides a clear indication of the stage of the

process you are going through. In the central work area, on the other hand, the

user adds all the necessary information on the opening of a CAPA, such as:

Type of action (corrective or preventive)

Description of Action

Departments involved

Areas involved

Estimated CAPA close date

Any notes

If the CAPA is opened manually, the user can indicate the source of Non-

Compliance in the "Relations" section. The latter may also refer to a flow that has

not yet been computerised with PRAGMA®. In this case, the reference to

"External Process" should be selected.

The PRAGMA® CAPA process contains the Tasks Module, that is to say the tool

that allows a manager to assign (to another user) one or more


8


s4bt.it/en/pragma

tasks necessary to resolve the non-compliance. The system tracks the allocation

and performing of activities and makes the details accessible to all the resources

involved in the process. In this way PRAGMA® puts different departments in

contact with each other, promoting communication and sharing of important

information.

PRAGMA® can automatically generate a GANTT in the form of a Microsoft

Project file from the business plan set within the CAPA process.

During the definition phase, the user can add specific documents to the process

in various formats (word, excel, ppt, pdf, mp3, mp4, jpeg, etc.) directly from one

of the folders on their own computer or the corporate network, via the

Attachments Module


9


s4bt.it/en/pragma

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.

2. Follow up

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

The process, therefore, passes to the next section. In just the same way as the

CAPA process progresses on paper in PRAGMA® it involves multiple


10


s4bt.it/en/pragma

Departments and multiple resources, called on to approve by adding their

signature, i.e. by typing their password into the system. With PRAGMA® signatures

may be organised by levels. This means that the "second level" signatories cannot

sign unless those of the first level have already done so. All this ensures

compliance with the structure of the process and internal procedures. To move

to the next phase of the flow, all signatories must approve by entering their

credentials, as shown in the figure below. If a user does not approve, the process

automatically returns to the previous stage.

A particularly interesting feature is the ability to create proxies. In the event that

a person is absent or unable to sign their approval, the system automatically

involves all those who have been temporarily authorised to sign.


11


s4bt.it/en/pragma

In this way PRAGMA® ensures that the process continues to run smoothly,

regardless of the individual involved.

To close a CAPA process it is necessary to carry out the preliminary activities for

the resolution of the anomaly, defined by the Tasks module.

At this point in the process, all those responsible for individual tasks record the

completion of their respective activities, also indicating the effective start and

end dates.

3. Evaluation of effectiveness

When all the resources involved have signed, the process moves from "Follow up"

to " Evaluation of effectiveness " and, in this phase, PRAGMA® highlights the real

end of the CAPA (which may differ from that forecast) and the existence of any

overdue tasks.

At this point in the flow, the responsible user must indicate whether the Action

Plan was effective. In the notes field, he/she can also add any details that will

immediately be shared with any other company employees involved.


12


s4bt.it/en/pragma

Even at this stage the user can justify any delay by loading specific documents

to the system to justify the delay in closing the task. PRAGMA® in the meantime

will continue to track every bit of information on the evolution of the process.

The process is considered closed when all the tasks necessary to eliminate the

non-compliance have actually been completed and all those involved have

signed. Depending on the result specified in the result field, the CAPA closure

can be of two types: Closed effective or Closed not effective. In the latter case

PRAGMA® will automatically generate a new version of the process, from which

a new Action Plan will be created.


13


s4bt.it/en/pragma

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.


14


s4bt.it/en/pragma

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.

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.)


15


s4bt.it/en/pragma

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.


16


s4bt.it/en/pragma

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.


Documents

Copyright © 2016 S4BT Srl s4bt.it/en/pragma · s4bt.it/en/pragma Web-Based Platform: PRAGMA® is easily implemented in any type of business organisation. Precisely because it is