Copyright © 2016 S4BT Srl s4bt.it/en/pragma€¦ · s4bt.it/en/pragma B. Direct access through the Filters tool (process object, tasks, attachments, keywords, etc.) using which you

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Copyright © 2016 S4BT Srl

s4bt.it/en/pragma

http://www.s4bt.it/pragma

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Audit process

The Audit is a fundamental process within a company as it allows the risks

associated with compliance to be identified and thus the most appropriate

corrective action to be taken. In most cases, Audits involve different

departments, resources and flows. Precisely for this reason it is important to

manage in a "centralised" manner throughout the life cycle of the audit: from

planning, through execution, up to the final analysis.

Why is it important to computerise the Audit Process with a

dedicated software

Computerising such a strategic process as audits using a dedicated system helps

companies to:

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

system guides users in carrying out their activities

2. Track and monitor the impacts of Audit on the processes and organization


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3. Centrally manage any resulting observations, offering the user a series of

tools ranging from simple corrective action to actual change control

4. Constantly keep track of the progress of the resulting observations

throughout their life cycle

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

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

PRAGMA®, allows a CAPA, Change or Non Compliance process, for

example, to be started directly from an Audit

This considerably increases compliance with regulatory standards while reducing

errors and wasted time.

Companies that have computerised the Audit Process with PRAGMA® have

improved their performance for at least 6 different reasons:

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.


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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.

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. A new Change or Non-Compliance flow can be

created from an audit process, for example. All this gives the Company

Quality System an even more holistic approach.


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How PRAGMA® computerises the Audit Process

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

CAPA process in three phases:

1. Planning the Audit

2. Execution

3. Management Comments

Based on the signature books and permissions

configured on the platform, PRAGMA®

automatically selects users to be involved in the

process and sends them an automatic email.

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

any documents to be signed on their own home page. PRAGMA® guarantees

full compliance with the provisions with regard to Data Integrity since each

company employee has their own login credentials (ID and password).

Each user involved in the system can enter the process of interest in two different

ways:

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


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B. Direct access through the Filters tool (process object, tasks, attachments,

keywords, etc.) using which you can quickly select the information of interest.

1. Planning

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

guides the user in carrying out their individual activities. PRAGMA® thus makes

sure that resources and departments respect the structure of flows and internal

company procedures.

In the Planning phase, the user must specify the type of audit (internal or

external), a detailed description of the purpose of the inspection, the start and

end date, the departments that will be involved and the teams that will

participate in the inspection itself. Such


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information will then be available to the involved and authorised company

employees.

In this phase, as well as in all other flow steps, users can "computerise" their own

Action Plan using the Tasks Module: A specific feature by which certain tasks can

be assign ed to other people to help resolve and eliminate non-compliance.

PRAGMA® tracks the assigning and performing of tasks. In this way everyone

involved is always informed about the status of the job.

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

Project file from the business plan set within the Complaints Process.


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In addition to Tasks Module, PRAGMA® also contains the Attachments module,

useful for adding specific documents to the process in various formats (power

point, word, excel, pdf, video, jpeg, mp3, mp4, etc.), directly from one of the

folders on your computer or the corporate network.

Once loaded into the process, the attachments are immediately available for

all resources involved, and - of course - authorised. In this way, PRAGMA® also

favours the complete and transparent circulation of information. This feature is

also particularly significant during inspections.

To move to the next section of the process, PRAGMA® requires that all those

involved approve by signing (i.e. typing in your password).


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The platform involves only the authorised departments and resources, respecting

the structure of the process and the organisation chart. This ensures that

everything works exactly as planned and excludes the possibility of making

mistakes. If a user is unable to approve, PRAGMA® automatically involves

additional company employees previously authorised by the department as

proxies for signature. All this ensures that the tasks are carried out without

interruption, regardless of individuals.

2. Performing the Audit

At this point in the workflow, Quality Assurance records the observations

highlighted during the inspection, specifying the level of criticality as follows:

- Critical observations

- Increased observations

- Fewer

- recommendations

PRAGMA® also provides the ability of tracking information on any action taken,

using the platform-specific feature called "Immediate" actions.


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3. Observations management

For each previously recorded observation, PRAGMA® automatically creates a

related new "Observation" process. If, for example, an Audit reveals 3 different

anomalies, these will create many new "Comments" flows.


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The Observation Process begins with the definition phase, in which PRAGMA®

shows the same information already included in the Audit Execution Phase. In this

way the system speeds up the work of employees, rendering unnecessary the

transcripts that would, however, be required with a "paper" flow management.

During the Observation Definition, the system guides the user through the

anomaly resolution process, providing four different alternative routes:

1. Create a specific computerised Action Plan using the Module Task


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

process whose origin is precisely the Audit / Observations process

3. Solve the anomaly through a change request: PRAGMA® then

automatically opens a Change Control Process

4. Remedy fault displaying Non-Compliance. In this case also PRAGMA®

automatically generates a corresponding Non-Compliance process.

Essentially PRAGMA® adapts perfectly to all types of needs of the Quality

Assurance department, which will, of course, choose the best strategy based on

the nature of the observation and its own quality system.

In any case all the involved and authorised resources are constantly updated on

the status of the job.


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The Definition phase is followed by that of Follow Up, in which the execution of

preliminary activities for resolving the anomaly are tracked.

The Audit Process is closed only when the tasks necessary to resolve all the

observations have actually been completed. In general, the period from

Planning the Audit to completing the tasks necessary to resolve anomalies can

last several months. That is why PRAGMA® proves a particularly effective tool for

tracking each type of development within the flow in the course of time.

File and Report

To correspond to each process, PRAGMA® automatically generates a

File, a protected pdf document summarising all the workflow 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.


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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.

To monitor performance, users who use PRAGMA® have the possibility to create

custom reports, extracting all the information recorded in the process (as shown

below).


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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 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

5. Line graph

6. Report in Excel format

7. Report in PDF format (Create PDF)


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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.


Documents

Copyright © 2016 S4BT Srl s4bt.it/en/pragma€¦ · s4bt.it/en/pragma B. Direct access through the Filters tool (process object, tasks, attachments, keywords, etc.) using which you