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COMPLIANCE:
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Compliance
support in BatchMaster® Enterprise is
as comprehensive as the range of regulations
process manufacturers are required to meet.
Throughout the system, the commitment to meeting
regulatory compliance is pervasive and all-encompassing.
Specific areas of interest are:
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Pervasive
Compliance: The number one determinant
in software development at BatchMaster®
is Regulatory Compliance, and every new feature
and function is tested against compliance
standards and requirements while trying to
maintain maximum flexibility for those whose
compliance needs are fewer. Every effort is
made to ensure compliance with FDA’s
21 CFR Part 11 and cGMP standards, including
electronic signatures and audit trails. Warehouse
and Shipper information fully complies with
the Bio-Terroism Act.
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MSDS
& SARA: The MSDS/Compliance module
has powerful features that will automatically
generate Material Safety Data Sheets in full
compliance with the OSHA Hazard Communication
Standard, SARA Title III, ANSI, and virtually
all similar government reporting requirements.
This module is designed to accommodate any
required changes to meet new regulations immediately,
without the need for a program update. The
output MSDS is created as a Microsoft Word
document. New MSDS and Labels generated automatically
upon Formula change, based on Customer History,
Finished Goods, Formulas, Sales Orders or
Raw Materials. MSDS/Compliance documents will
read calculated Laboratory values as well
as Quality Control specifications and results.
"SARA" (Superfund Amendment and
Reauthorization Act) processing for year-end
or other defined periods.
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| Quality
Control lies at the very heart of BatchMaster®
Enterprise and no-one offers more opportunity
and flexibility. QC test without Lot creation
if desired (sampling). Test at every stage
of the Supply Chain: Receipt of Raw Materials,
Pre-release to production, In-process testing
while making, on finished goods after filling,
and pre-dispatch (Sales), as well as ordering
re-tests of existing inventory at any time.
Optionally make any testing compulsory. Maximum
flexibility of test specifications: establish
the test description, assign it to an item
or formula and decide at that level whether
the expected result is Numeric, Alpha or simple
Pass/Fail. User-specified sampling plans,
target values, control limits and maximum
allowable defects. Optionally elect to reject
an entire shipment. |
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| HACCP
(Hazard Analysis and Critical Control Point)
is a production control system designed originally
for the food industry but now becoming widely
used over many process manufacturing sectors
where even the Coatings industry is becoming
concerned with bacterial contamination of
paints and other coatings. It is a process
designed to prevent rather than catch potential
hazards and BatchMaster® Enterprise has
implemented an HACCP module across all functions. |
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FDA
Regulations are further supported with
fully compliant Nutritional Reporting and
Labeling functionality. Analysis of the formula
ingredients is performed via the Laboratory
module (seamlessly) using a standard USDA
ingredients database from which physical properties
can be imported directly into the BatchMaster®
Enterprise inventory database. Labels
can be customized for individual product packaging
and international markets. Five separate FDA-compliant
nutritional reports are also inherent.
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FDA
batch audit requirements are met with specific
reports such as Batch Ticket Audit Report,
Consolidated Transaction Report, Lot-tracking
Report and QC Item history Report.
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| Lot
Traceability also lies at the heart of
BatchMaster® Enterprise. Designed for
maximum flexibility and instant recalls, Serial
/ Lot Tracking starts with customizable Lot
Number configuration and automation of lot
sizes. Prevent use of lots which are in Quarantine,
Expired, or are too close to Expiry to be
shipped. Select lots for use or shipment using
numerous Lot-picking strategies – prioritize
by FIFO, LIFO, FEFO and more, choose by Date,
Number, QC Results or user-defined Lot Features.
On-screen access to your relevant Lot data
from any transaction screen. Lot explosion
both forward and backward down to end-consumer
level, with export to Microsoft Office®,
facilitates a full product recall within seconds. |
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Compliance
