Document management for regulatory compliance

The case of Lacer

% of time reduction for audit preparation


Hundreds of documents managed

The client's problem

Pharmaceutical companies are obliged to apply strict quality and safety standards, part of which involves having controlled documentation reflecting the procedures and results of their application. 

This documentation must be efficiently mapped and distributed to comply with annual audits, and it was being performed with inadequate and inaccurate tools.

The client's objectives

The main objective was to build a digital document repository that would allow it to create, review, distribute and store the documentation generated for quality standards. 

The system should serve both the quality department responsible for maintaining the documentation, as well as the other areas of the company that are the recipients of the documentation.

Main challenge

To build a robust, safe and efficient system that meets stringent quality standards. 

The main challenge was to meet the needs of the quality department in terms of control and security, while maintaining a friendly environment for the rest of the company to use the documentation in their regular operations.


After analyzing and diagnosing the situation, IN2 defined the implementation of an Open Source Alfresco document manager as a centralized repository for documentation controlled by regulations. This repository has all the information about the documents (metadata), records and the life cycle audit for all of them. 

For the digital management of documentation, a series of workflows were created to cover tasks such as document preparation, review and approval, electronic distribution, validity control and the removal of obsolete items.

Achieved results

The successful implementation of the solution has facilitated the management of hundreds of documents and reduced the time required to prepare the annual audits for the renewal of quality certifications by 50%.

Solution implemented on the Open Source Alfresco document manager.
System approved for ISO and GMP standards.
Review, approval and distribution workflow configurable for each document in the system.

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