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Total control on Documents, Records and Training for ISO 9001:2008, ISO 14001, ISO 17025, ISO 13485, ISO 15189, ISO 14971, QS...

Here you can download a PDF document with detailed information.

Also, there is a Powerpoint presentation that you might use to introduce the software to others.

Do you need to meet the FDA Final Rule, 21 CFR Part 11 requirements? This is your software!

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Document index


In short

Our software Sistema Docal consists of 3 modules:


Advantages

Sistema Docal offers at once:


Introduction

Quality Assurance and/or Environmental Management according to international standards (ISO 9001, ISO 14001, QS...) requires a great effort concerning organization and management, along with a significant cost.

As a consequence, many documents need to be managed, including:

This complexity increases as some documents depend on others, so changes in one document can require changes in those related to it.

Also, when the document is a form, its workflow does not end with distribution, but must go on through different users gathering pieces of information, decisions or tasks from each one.

On the other hand, the management of Occupational Safety requires a similar treatment.


General description

Sistema Docal allows computerization of every process related to Documents, Records and Training Control, through a friendly interface that provides an easy management as long as very few hardware requirements.

When an Internet/Intranet server is available, the main documents can be distributed easily without requiring any help from the webmaster.

Our customers include a wide variety of sectors from manufacturing to laboratories, hospitals or schools. They have got ISO certificates from Bureau Veritas, DNV, Lloyd’s, Aenor and many other certification companies in 8 countries.

Below we give a brief explanation of the most valued features. Some descriptions and screens have been simplified.


The Explorer

The Explorer inside Sistema Docal is a powerful tool for easily getting reports and manage every item. It allows to create, modify or delete items (users, departments, types of documents…), creating reports of the information shown.

Its layout is similar to Windows Explorer, with a tree in the left, elements listed on the right and a toolbar above them.

It also provides powerful search functions as well as the capability to generate reports as Word or Excel documents.


Documents under development

In order to guarantee that the documents can’t be modified by non authorized users, they are stored inside a database, not as disk files that could be modified or deleted by users with access to those folders.

In addition, the software allows to choose freely what tool is the most suitable for a single document. Often it is a word processor such as Word, but documents can also be Excel workbooks, PowerPoint presentations, AutoCAD designs or any other file.

When a form is to be designed, the E-form tool is recommended, so you can easily automate all the workflow for the form, from creation to closing, avoiding entirely the use of paper.

E-Forms can ask the user for a single piece of information (a name, number or date) but also an entire file can be inserted when allowed.

On the other hand, it is possible (and recommended) to create templates for each type of document. This way, every new document of that type will have the same look.

Templates can be of any kind, but when it is a Word or Excel document, it is possible to insert bookmarks to tell Sistema Docal exactly where we want the document code, title, date of publication, date and time of printing...


Approval

Approvers can go-ahead the document but also return it to the writer to ask for changes. Also, authorized users (critics) can add comments to be read by the approvers.

The software guarantees that the document can’t be modified during approval or later, unless it is returned to its writer.

When the document to approve is an E-form, the approver can fill in a test form to find out whether the designed workflow is correct or not.


Distribution

When a document is published, every authorized user can have access to it. If it is a new version, the old one has been retired automatically to assure that users are not using obsolete documents.

A powerful search screen allows users to easily find the desired documents.

It records who opens every document, when and from which computer.

Also, when opening a Word or Excel document, it is possible to prevent users from printing it or saving local copies.

When the document is an E-form, end users can “start” and fill in new copies of it. Every piece of data is stored in the database, so it is available for report.

All of this makes possible to completely avoid the use of paper, but hard copies are allowed for users that don’t have a PC in their workplace.

Also it is possible to distribute published documents through an Internet/Intranet server (see below).


New versions

Published documents that are to be changed are not modified, but copied to the development area from where, after approval, will be published. On publication, the new version “pushes” the previous version to an obsolete area, avoiding further access. Only authorized users can view obsolete documents.

The software guarantees that published and obsolete documents can never be lost or modified (proper backup of database is required).


Dependencies between documents

The software shows two dependency trees for each document.

One lists the base documents for the current document.

The other shows those for whose the current document is a base document.

From this information, the software is able to warn about changes in documents that could affect others.


Statistics

A variety of statistics options give valuable information that can be used to improve the use of the software.

It gives the mean time needed for document creation/approval (global or detailed by user), number of created documents, number of new versions...

Statistics are given as text or as graphic reports.


Mail tool (only Enterprise edition)

A complete message system is included. Many messages are sent by the software itself in order to warn approvers than must go-ahead a document, writers whose approver has returned the document, users that have received a new document... over 40 types of messages can be sent.

Messages are not private. Administrators can audit every message.

When a new message exists, a light bulb next to Windows clock warns the user even if not logged to Sistema Docal.

Additional software (Agente Docal, more information at the end of this document) can send every message by e-mail, so the users can receive them in the inbox tray through their usual e-mail client (Outlook, Lotus Notes...).


Event Log (only Enterprise edition)

It records all activity, storing information about user, date and time, action and PC. So, over 50 activities like login, logout, document creation, approval, opening or printing can be viewed at any time by authorized users.


Change suggestions (only Enterprise edition)

Change suggestions provide an easy way to manage suggestions for document creation, change or retirement made by different users.

Administrators can reject suggestions, or they can decide to start a new document, a new version of an existing document in order to include the suggested changes, or retire the document to the obsolete area.

Change suggestions keep tracking between users asking for changes, documents and response given to the suggestion by administrators.


Intranet/Internet distribution (only Enterprise edition)

A wizard creates a complete website for the published documents. The website can be personalized for each user, or can be generated as a whole site for all users.

Only published documents (all or selected) can be uploaded.

HTML templates are available, so it is possible to change colors and graphics that match those of the company website.

Messages are sent to users giving its personal URL (when it exists) or the global URL.


PDF distribution (only Enterprise edition)

PDF distribution is an optional feature within Enterprise edition that allows to give in the document as PDF to end users, while keeping the original document hidden (Word, Excel, AutoCAD...).

It is useful in some cases:

A mixed mode is allowed, e.g., you can insert a PDF only for those documents that you want distribute using that format.

To create PDF files you need to use proper software like Adobe Acrobat or PDFcreator.


E-forms module (optional)

The E-forms module is an extension, sold separately, that provides additional functionality over the basic Document control module.

Consists of a design tool that allows to easily design electronic forms that include linear workflow based on sections and fields.

Each section is intended to be filled by a single user and includes one or more fields. Many types of fields are available: text, memo, number, date, time, system date and time, boolean, multiple options, file and separator.

Some advanced features are:

After a newly designed E-form is published, end users can “start” new E-forms and fill in data. Every time a section is completed, the software looks for the user responsible in the next section and sends a message asking the user to fill in that section.

A special section (Actions) can be used to start new E-forms, make new Change suggestions or assign tasks to certain users.

E-forms are widely used to manage nonconformances, corrective and preventive actions, customer relationship as well as manufacturing records, proposals of purchase and almost any kind of record.

Stored data can be viewed as text or graphics, or can be exported to new or existing Excel workbooks.

For developers, there is also available an OCX component that allows to use E-form functionality from within your corporate software (more information at the end of this document).


Training control module (optional, only Enterprise edition)

The Training control module is an extension, sold separately, that provides additional functionality over the basic Document control module of an Enterprise or Corporate edition.

Main features:


Editions

Our software Sistema Docal can be useful for big, medium and small companies that need to manage documents and records.

All editions can be extended with the E-forms module.

Only Enterprise and Corporate editions can be expanded with the Training control module.


Requirements


Server side

Every company can choose between:

The hardware requirements in server depend on the database chosen and must be requested from Microsoft or Oracle.

When using SQL Server, SQL authentication should be enabled. Windows authentication is available but not recommended.

When using Oracle, additional requisites exist in the client side.


Client side

Current version 5.50 is a full Windows client.

It can be installed on Windows 2000/XP/Vista/7. If needed, it can also be installed on Windows 2003/2008 server, but it is not usual to have it in the client side.

There are not other requisites when SQL Server is in the server side.

When using Oracle in the server side, an oracle service name must be created using the same name for all the clients. Also, the most recent version of the “Oracle provider for OLEDB” must be installed in the client side. Both “Oracle provider for OLEDB” originally shipped with Oracle 8.1 and Oracle 9 were not suitable for use with our client software because they contain critic bugs, solved later.


Customer support

All the licenses of Sistema Docal include three months of updates from our website and full support by telephone and e-mail. This service can be renewed annually.

We publish in our website at least a new version/revision every year, providing full compatibility with every new version of Windows, Office and other related software.


Our customers

The Sistema Docal has been chosen by companies belonging to Mapfre, Iberia, Hero, Abbott Laboratories, Cegasa, Telefónica, Cirsa, Altadis, Crown Cork, Alsat, Heimbach, Norte, Samca, Recall Information Management… and others, in 8 countries.

Our customers have successfully obtained certifications by Bureau Veritas, Det Norske Veritas, Lloyd's, Aenor... according to ISO 9001, ISO 14001, ISO 17025... and even FDA Final Rule, 21 CFR Part 11.


Additional software (optional)


Agente Docal for SMTP

This Agent for the Sistema Docal sends by e-mail a copy of every message generated inside the system by using an e-mail account in a SMTP server.

Main features:


OCX component for developers

This OCX component is a control intended for developers that want to use our E-forms from within their own corporate applications:

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