Production Phases & Electronic Batch Record (MES & EBR)

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 the life sciences industry such as pharmaceutical, biotech, cosmetics and food industries along with storage of consumer goods and medical device industries that need to accommodate GMP requirements for manufacturing.

Developed and verified for its manufacturing procedures, ip6 facilitates 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 that is accessible and reliable.
  • Manages the life cycle of 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.
  • Electronic batch record.

Auxiliary activities

  • Cabin cleaning and Scale calibration
  • Vouchers
  • Required materials list (BOM)
  • Job scheduling
  • User activities control
  • Historical weighing report
  • Historical cleaning report
  • Audit trail reporting and custom reports
  • Deviation management

All manufacturing information is automatically recorded in the electronic batch record. Each operation and device used is recorded, as well as the operator’s information and time stamp.

Ip6 software modules provide

  • Scalability, the different modules can be implemented standalone or integrated in a single database.
  • Unification of the information from its origin for the whole organization
  • Flexibility, with a high level of parameterization.
  • Full traceability, of materials, operations and operators
  • Integration with ERP corporate systems (SAP, Navision JDE, Movex, etc..)
  • Real time management of physical devices, bar codes, radiofrequency, and connections to automation and equipment’s.
  • Ip6 provides compliance validation with GMP and FDA CFR21 part 11.

Telstar Value Services

We work alongside our customers in close partnership, supporting them throughout the full life cycle of their plant and equipment to ensure lasting business success.

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