21 CFR Part 11 Compliance

Pharmaceutical Regulatory Compliance

V5 Formula Control Scale System is the perfect way to ensure 21 cfr part 11 compliance and material control without costly giveaway or out of specification batches. Brochure

The system ensures each weighed ingredient has enforced +/- unique tolerances, preventing recipe completion until all ingredients are weighed using the green speedometer style target zone.

The systems scans and validates lot numbers, providing real time inventory usage and eliminating costly traceability paperwork.  For ERP Integration, see ERP Page

Hundreds of configuration options exist in the standard system, enabling each workstation to be setup to handle many applications including batch, campaign and combination weighing.

The system provides an EBR (Electronic_Batch_Record), including a digital review and sign off procedure in compliance with 21 CFR Part 11.  Data security meets the ALCOA principles and GMP requirements.

User Friendly Batching Screens

The simple to use intuitive system allows management to schedule production jobs (or import from ERP) to 1 or more area specific batch terminals.

Each ingredient step has unique conditions (weighed, key entry, counted, bulk control ect) and jobs can be weighed in horizontal (campaign) or vertical (batch) modes, in sequential or none sequential modes.

The flexible system allows strict batch compliance, or the option to batch edit the formula or schedule on the fly with easy 21 cfr part 11 compliance.

Operator specific logins allow varying levels of access and control, recording all  activity.

Safety, SOP’s & QA

Commodity specific messaging ensures operator confirmation with requirements such as Allergens, Safety Instructions, HACCP & SOP’s.

Import the latest GHS Safety & Allergen Symbols to display to operators at the correct time, each time.

Create a custom library of quality assurance questions and answers to facilitate the requirements of HACCP, COSHH, SOP’s and GMP (plus many other qualify and safety standards).

The system records responses to batch specific questions, allowing for a paperless QA environment.

Ingredient / Batch Labels

Many 21 cfr part 11 compliance printing options exist to identify Ingredient / Batch printing applications.  (Click here for finished product label printing).

Standard Label Fields

Job & Batch Number, Recipe Code, Recipe Description, Operator Code & Name, Produced Date & Time, Batch Expiration, Mix Size, Batch Size, Bag Number, Weigh, Container Count.

Labeling Events (events which generate labels)

Ingredient weigh, lot change, batch end, container change, separate ingredients, non-weighed items, suspended / aborted batch.

Hardware Specifications

The SG15 Touch Screen is a NEMA4X (IP66) heavy industrial computer designed for harsh manufacturing  applications. It is usually supplied with a stainless steel fabricated stand with a built in scale, however the terminal can be supplied and connected to most existing scales and balances using internal connections. 21 cfr part 11 compliance.

The terminal is constructed using compression seals to maximize ingress protection.  Cables entries are sealed and protected.

The Terminals are supplied with software applications which run on Windows or Linux as a background operating system.

Stainless steel stands, scales and printer enclosures are fully welded and polished to high manufacturing standards.

Supported Peripherals

• Weighing Equipment (4 x analogue inputs, 4 x serial RS232 inputs).
• Bar-code Readers (hardwired USB or Bluetooth)
• Label & RFID Printers (network)
• Report Printers (network)
• Temperature Probes (serial RS232)
• PLC & switchgear (serial or network)

Networking

The terminals utilize TCP/IP communications to a database using a wired or wireless LAN.  This allows multiple Terminal to communicate with a central database.  Terminal support is conducted using VNC or RDC.