ALCOA Data Integrity, Document Control Management DCM, Good Documentation Practices GDP

Document Management Software Application

In this article, you will learn about the most innovative Document Management Software Application for the FDA-regulated companies. Moreover, you can learn how to get a free Document Management Procedure Template to handle your document control activities fast and easily.

DOCUMENT MANAGEMENT SOFTWARE APPLICATION

A Total Solution to Document Management, Analysis & Reporting.

This cloud application allows you to create, handle and control all your document records and approvals. In addition, it can bring the follow-up and notifications necessary to guarantee that all your documents are properly updated and approved manually or electronically, including:

1. Existing Documents.

2. New Documents.

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SOFTWARE FEATURES

Access Control & Password Security Encrypted – Data Privacy & Integrity

Create SOP’s Procedures, Batch Records, Validations, etc.

Assign Training to Procedures documents.

Approve Documents online.

View & Manage Approval Process.

cGMP Audit Trail

Dashboard to View Pending and Expired Tasks of each Employee.

Integration with other QMS Modules, such as: Training, CAPA, Change Controls, Audits, etc.

Data Backup and Restore

Certification – CSV Computer System Validation, 21 CFR Part 11

Technical Support

Powerful Tools and Security Controls (21 CFR Part 11 Compliant)em software

This application facilitates the identification, execution, documentation, and evaluation of the effectiveness of documentation activities. Moreover, it brings the mechanism to document the history records and register its signature in a signature log.

It provides the power and capability to improve the Document Management control activities to comply efficiently with the cGMP’s and regulatory compliance requirements. It is specifically designed for the pharmaceutical, biotechnology, and medical devices industries that want to reach the top level in competitiveness.

Application Software Features

It applies to any department that provides or performs any GxP documentation (e.g. human resources department, manufacturing, quality, incoming, warehouse, etc).

TRAINING MANAGEMENT PROCEDURE TEMPLATE

WHAT IS A DOCUMENT MANAGEMENT PROCEDURE TEMPLATE?

The cGMP Document Management procedure template is a downloadable document ready to use and customize to handle your company’s needs of document control as per 21 CFR Part 211 and Part 820. This document is fully editable in MS Word and contains copyright information only authorized to use within your company site. Another distribution outside your company is prohibited.

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ORDER ONLINE DOCUMENT MANAGEMENT PROCEDURES & TEMPLATES

Now you can download a Document management document and templates fully editable in MS Word or get a hard-copy and Amazon Kindle format, ready to fill, and use according to your cGMP needs, check the following documents and see more information at the CIQA Shop.

Order a Hard copy document

Download in MS Word or .pdf

Order Amazon Kindle Version

Order a Hard copy document

Order Amazon Kindle Version

REFERENCES

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Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!