Our production solutions have as objective to resolve typical problems in this crucial area for the product's productivity and quality.

Therefore, we focus on the creation of punctual solutions for different specific activities.

Raw material fractioning

This process should be performed detailing the precise amount of the different raw material consumption that will become the laboratory's products.

CITSForm allows ensuring the traceability of all information associated with each batch, by implementing a great number of process controls that can guarantee that each of them is perform with the highest quality in accordance with the existing regulations.

CITSForm

It is our answer to the need for completely controlling the raw material fractioning process. This solution guarantees that the raw material consumption will be done un a controlled manner and with the highest quality standards.

The process quality

• It allows controlling each and all of the formulation and fractioning processes: Material identifications, material weighting, labelling and bulks reviewing to ensure traceability, etc.
• It complies with the cGMPS, the FDA’s 21 CFR part 11 regulation and it is completely validated according to the GAMP 5.
• It allows setting and executing periodic controls to the scales associates to the system.
• It keeps the cabins cleaning controls and prevents any weighting until that cleaning is informed to the system.
• It registers every piece of information obtained on each weighting process and identifies the product and weighting order, its weighted component and its batch, its container's tare, its net and gross weights, the Operator who weighted it and the time and date when it was done. Besides, it displays our material tampering precautions and it presents the European and American pictograms.

Information security

• AuditAudit-Trail is a tool configurable for all system applications and it complies with the CFR 21 part 11 requirements (Timestamp, User, prior and current attribute values, etc.).
• Complexity level of the parameterizable password (Length, complexity, expiration date).
• Electronic signatures for GMP sensitive operations (parameterizable to each operation).
• User session management and their duration. Accounts blocking due to inadequate access.
• CRC to the registration level.
• Administration levels and profile management.
• Operations’ high granularity allows setting detailed accesses to be granted to each profile.
• It enables the connection to any type of scales, labelling printers and barcode readers.
• It considers the problems of each area, for example:
  • Products with very low density.
  • Adjustments based on product’s power.
  • Liquid and bulk weighting.
• It allows to customize and enlarge the reports and label database.
• It enables the direct or indirect integration to any ERP system (SAP, NPCS, Axapta, etc.).
• It is based on Windows platform and open databases (For example: MS-SQL Server, Oracle, Access).
• As well documented as it is, it includes validation documents and FAT.