Manufacturing Execution System

Ip6-MES manages the design and implementation of procedures and protocols of production following standard S95 and S88. It provides full traceability of the process, unalterable batch data record and automatic generation of reports and audit trail.

The Ip6 MES module was designed for life sciences industry such as pharmaceutical, biotech, cosmetics and food industries, storage of consumer goods and medical device industries that need to accommodate GMP requirements for manufacturing.

Developed and verified for its manufacturing process ip6 is FDA compliance, meeting all regulatory actions provided by an electronic batch record and electronic signature (US FDA21 CFR Part 11).

The features of this system, once implemented, can be summarized in the following points:

  • Manages the production workflow linking the recipe with the execution of the procedure, since the order is received to the release of the batch.
  • Set the master recipes for a product line or facility site.
  • Schedule production orders and manages resources for execution.
  • Automatically assigns recipes to production orders.
  • Executes the order according to the recipe and instructions (SOP), electronic procedure previously designed and approved.
  • Creates an electronic batch record accessible and reliable, fully GMP compliance.
  • Manages the life cycle of all critical objects.
  • Provides full traceability and inviolability of data objects.
  • Production order management execution by phases and in Web environment.
  • Paperless guided work.
  • Direct communication with equipment.
  • Management of deviations and alarms.

All manufacturing information is automatically recorded in the electronic batch record. Each operation and devices used is recorded, as well as the operators information and time stamp.

Auxiliary activities

  • Deviations and alarms management
  • Cabin cleaning
  • Equipment calibration
  • Products treatment
  • Vouchers
  • BOM, Required materials list
  • Task scheduler
  • ctivities by user and user profiles
  • Warehouse management
  • Audit and activity history
  • Audit trail reporting
  • Personalized documents.

Benefits from the implementation of Ip6-MES

When a manufacturing plant is committed to implementation of Ip6 MES, acquires added value after star-up of the system. The use of the solution allows to obtain the following benefits:

Qualitative benefits

  • Total quality assurance throughout the process.
  • Process automation link.
  • Time control and optimization
  • Centralized unique information
  • Costs.
  • Scheduling.

Quantitative benefits

  • Optimization or reducing the use of MP.
  • Overall times reducing.
  • Productivity.
  • Improve equipment utilization.
  • Reduction of scraps and reprocessed.
  • Reduced errors and non-conformities.
  • Reduction of time in the design of new products.
  • Full control of the state of stock

Operating benefits

  • The execution with electronical tools.
  • Dynamic information  for better decision making.
  • Integrates GMP in the SOP.
  • Reduce costs associated with manual approval processes and actions.
  • Reduce time in the introduction of new products and changes in production due to powerful tools and information management.