PlumERP LS - ERP for Life Sciences

ERP Tailormade for Life Sciences Industry

PlumERP LS (for Life Sciences) is an integrated cloud based ERP solution tailor made for Life
Sciences industry. It is designed to meet the needs of rapidly growing Life Science businesses with
industry specifc requirements. It addresses the needs of the major Life Science industry segments:
Pharmaceutical, Contract Manufacturing, Medical Device and Bio Technology, and is packaged for
quick implementation and allows companies to gain the effciencies of the large life sciences companies
at a fraction of the cost.
PlumERP LS is a cGMP compliant ERP with electronic batch records that streamlines the entire process
of manufacturing products made under Good Manufacturing Practices (GMP). It simplifes the
documentation and approval procedures to reduce production times. The SOP requirements and
quality checks are built into the software to prevent errors, to maximize quality and to assure GMP
compliance. It can be viewed remotely from any location and has individualized security settings on
every screen. The net result is better effciency and higher quality than can be achieved with paper
based systems. PlumERP LS by its design helps its customers to fulfll most of the cGMP requirements.
Pharmaceutical companies are driven by stringent norms and regulatory standards. From managing
critical manufacturing operations to delivering the quality products, solid integration is the need of the
hour. PlumERP LS helps you comply with the stringent norms and standards automatically.
Key Modules
Financial Management
Sales Management
Customer Relations Management
Procurement Management
Production Planning & Scheduling
Inventory & Warehouse Management
Quality Management
Plant Maintenance
Human Capital Management
Plum Analytics
Key Benefts
Effortless regulatory compliance,
with time-stamped audit trails, elec-
tronic signatures, document manage-
ment, security etc.
Integrated Batch and Product Trace-
ability from raw material to fnished
goods and distribution
World class quality assurance and
control features
Integrated suite eliminates manual
processes and reduces errors
360 view of customers across sales,
marketing, service and fnance
Real-time business intelligence for
informed and data-driven business
decisions
Copyright Plumsoft All Rights Reserved
Key features specifc to life sciences industry
Regulatory Compliance
Regulations come from many sources and include FDA rules (including 21 CFR Part 11 for
electronic records), REACH in Europe, GMP/GAMP, etc. and can include a combination of
prescribed practices and general concepts. PlumERP LS offers a robust framework in support
of certifcation and audit, including comprehensive change logs with time and date stamp,
business process management that can deliver approval criteria for key processes, as well as
request password validation for system-wide electronic signature capabilities.
Product Traceability
In all regulated sectors, the need for traceability is critical and fgures heavily in Good
Manufacturing Practice (GMP) requirements. PlumERP LS includes integrated lot tracking that
was designed to meet your industrys traceability demands. Traceability starts with the raw
material and fows through manufacturing, warehouse movements, fnished goods, and into the
fnal disposition of the items. Designed for the business needs of the future and leading edge
warehousing today, PlumERP LS offers comprehensive electronic batch tracking on the plant
foor to track products in process alongside inventory and fnished goods, including product
labeling, to assist in the battle with counterfeit products. Complete traceability throughout
provides relief in the event of audit or recall.

Operations - Production, Planning & Purchasing
Operations must apply just the right type and amount of ingredients and resources to produce
the required product in accordance with its specifcations. Your production planners will be
better able to schedule all available resources using advanced planning tools like MPS (Master
Production Scheduling) and MRP (Material Requirements Planning). They will coordinate with
R&D and Purchasing for all materials required, at the quality levels needed, just in time to
meet your aggressive production schedule. Operations is your companys proft engine that
must be equipped with the right mix of tools, procedures and resources to keep the business
humming.
Bill of Materials with Formula/Packaging
Production of both fnished goods and intermediates
Mix, Fill or Assemble
MRP and Master Production Scheduling
Batch Management & Lot and Serial Tracking
Full Traceability for Recall
Compliance reports
Material and equipment purchase orders
Material receipts and returns
Quality Assurance, testing & reporting
Inventory management & valuation
Stock transactions, warehouse transfers and more
To help companies adhere to compliance
guidelines, PlumERP LS offers following
functionality
Audit Trails - Associated with the creation,
modifcation and deletion of electronic re-
cords, time-stamped audit trails are standard
in PlumERP LS. The functionality records user
name, date, time, previous data, new data and
the reason for the change.
Digital Electronic Signatures - An electronic
signature framework includes tables, pro-
grams, actions and objects to store, confgure
and collect unique e-signatures, which are
permanently linked to the object and cannot
be modifed or copied.
Digital Signatures - Documents requiring
handwritten signatures, such as Certifcates
of Analysis or Technical Sheets, are generated
with an image linked to the specifc docu-
ment. The image plate is controlled and linked
to the user profle.
Electronic Batch Records - Eliminate costly
paperwork errors, speed up information
distribution and collaboration, and enable
strategies for improving product quality and
process effciency
Validation Scripts - Documentation describ-
ing various process controls deployed by
PlumERP LS is available. These scripts are fex-
ible in design, associated with clearly identi-
fed and documented procedures. They are
easily transferred or incorporated into custom
validation and cGMP documents to support
company initiatives.
Security Features - Several security stan-
dards safeguard against unauthorized use,
including automatic logoff after a period of
inactivity, auto logout after too many failed
logon attempts and logging of all user activity.
For more information:
http://www.plumsoft.com
Email: info@plumsoft.com
Copyright Plumsoft All Rights Reserved
Hyderabad, India
76/A, Opposite S.R. Club
Srinagar Colony
Hyderabad-500073, AP, INDIA
Phone: +91 988 543 1698
Ahmedabad, India
213, Dev Prime Offces
SG Highway
Ahmedabad - 380051, GJ, INDIA
Phone: +91 968 708 6167
Pune, India
#301, Indira Icon, Plot No. 13
S.No. 98, Right Bhusari Colony
Pune - 411038, MH, INDIA
Phone: +91 992 238 7776
Bridgewater, NJ, USA
991, US Highway 22 W
Suite 200, Bridgewater
NJ - 08807, USA
Phone: +1 732 801 9344
Quality Assurance and Control
Quality is so fundamental to the Life Sciences industry that it might arguably have been
treated frst in this discussion. Quality can be related to all your organizations functions: from
the integrity you show in entering into contracts and meeting agreed commitments; to the
ingredients and packaging you elect to include in your products; to the processes, facilities,
equipment and procedures employed in production; to the end products your organization
delivers to distributors and, ultimately, to consumers. Not only does your organization have
to self-regulate out of social responsibility, you are compelled to comply with federal and local
mandates. Quality Assurance relies upon rigorous testing methodologies, applied consistently
according to thorough SOPs. The metrics for many quality criteria are built into industry-
standard and other compliance reports customarily expected both down and up the supply
chain. PlumERP LS supports these standards and many other tests and procedures and SOPs
so that you can assure your organization is doing the right things, right!

Mobile ERP, On-demand Anytime Anywhere
PlumERP LS is mobile ready. Availability of on-demand software on all different mobile devices
will enable seamless integration, tracking, and optimization of tasks from inventory, production
foor, and warehouse management to capacity and materials planning and product quality
control. This is very essential feature for manufacturing plants which are usually located in
remote places, for QA people working at vendor location to access and enter data, and for
sales people who are often on the move.

Finally, a mid-market enterprise solution built for you,
priced for you, and Ready-to-Run
However you measure it, PlumERP LS offers you the opportunity to upgrade and integrate
the breadth of functions within your company and your supply chain in a single, powerful
framework that can evolve and grow with your business.
For more information:
http://www.plumsoft.com
Email: info@plumsoft.com
Copyright Plumsoft All Rights Reserved
Quality Assurance for R&D
Acceptance Testing and Materials Quarantine
Parameter Testing and reporting on
ingredients and experimental and modifed
formulas (materials substitutions)
Quality Assurance for Operations - In
Process and Finished Goods
Materials and packaging acceptance testing
before release
Sampling or continuous production testing
both in-process or fnished goods after fll
Presale testing
Sampling or complete testing of inventory
FDA Compliance Reports, Consolidated
Transaction Report, Lot Tracking Report etc.
QC Item History Report providing a list of past
QC tests for a specifed range of items
Non-Conformance Reporting
Quality Notifcations
Supplier Quality Management
Test Specifcation Management
Test Equipment Calibration
Plant Equipment Calibration
Sample Management
Statistical Process Control
Statistical Quality Control
Hyderabad, India
76/A, Opposite S.R. Club
Srinagar Colony
Hyderabad-500073, AP, INDIA
Phone: +91 988 543 1698
Ahmedabad, India
213, Dev Prime Offces
SG Highway
Ahmedabad - 380051, GJ, INDIA
Phone: +91 968 708 6167
Pune, India
#301, Indira Icon, Plot No. 13
S.No. 98, Right Bhusari Colony
Pune - 411038, MH, INDIA
Phone: +91 992 238 7776
Bridgewater, NJ, USA
991, US Highway 22 W
Suite 200, Bridgewater
NJ - 08807, USA
Phone: +1 732 801 9344