An is all it takes to change the way you work..!
IT’S TIME FOR QUALITY
“Quality” - The “Quality” - The “Production” was “Production” the was the “Digitalization”“Digitalization” The The inevitabilitysmart way forward! only concern only concern inevitability smart way forward! Realising for qualitythe need With for quality In the past the onus In on the past the onus on the needRealising the rapid advancement With the rapid advancement to gain the leadingto edge gainand the leadingin edge and production and marketing production and marketing technology, organisations in technology, organisations ahead of competition, stay ahead of competition, preceded every other preceded concern. every otherstay concern. are endowed with are endowed with organisationevery is striving organisation isopportunities striving Although, it ushered Although, proﬁtable it usheredevery proﬁtable to leverage opportunities to leverage to meet quality standards. to meet quality standards. regimes for the organisations, regimes for the organisations, electronic Quality electronic Quality Stringent Stringent quality control, the essentially crucial the essentially factor crucial factor quality control, Management Systems Management to Systems to assurance and checking assurance and checking quality more oftenquality than not more often than not maintain consistency maintain in consistency in practices an integralbecame anquality, integralminimise human was missing from was theirmissing from their became practices quality, minimise human production part processes. of productioninterference, processes. inspire scheme of things. scheme The veryof things.part Theofvery interference, efﬁciency, inspire efﬁciency, factor which was to factor deﬁne which was to deﬁne keep abreast of market keep abreast of market their success in the their imminent success in the imminent developments anddevelopments achieve and achieve future. future. higher levels of productivity higher levels at of productivity at one go. In all certainty, one go. it isInthe all certainty, it is the smart way forward! smart way forward!
ChangingChanging paradigms paradigms of Life Science of Life Science Industry Industry
IT’S TIMEIT’S FOR TIME TECHNOLOGY FOR TECHNOLOGY TO TAKE TO OVER! TAKE OVER! Today, Life Sciences Today, Industries Life Sciences that operate Industries as a that part operate of globalasproduction a part of global & supply production chain are& bound supplytochain are bound to comply with globally comply acclaimed with globally quality acclaimed standards quality to sustain standards their competitive to sustain edge. their competitive With it comes edge. theWith it comes the pressure of recurrent pressure auditsof that recurrent assay audits the consistency that assayofthe compliance consistency to of thecompliance set standard to the operating set standard operating procedures. Failingprocedures. which, can Failing impact which, the marketability can impactofthe themarketability ﬁnal product. of the ﬁnal product. For organizations, For operating organizations, under such operating inflexible under regimes such inflexible can be arduous regimes besides can becomplete arduous besides dependence complete on dependence on human skills can prove human to be skills counter can prove productive. to be counter In suchproductive. scenario, organizations In such scenario, are left organizations with little choice are left but with to little choice but to keep trend with technological keep trend with advancements. technological advancements. With Motto Systems’ WithGMPProMotto Systems’ (A Global GMPProEnterprise (A Global Quality Enterprise & Compliance Quality Management & Compliance System) Management offering System) offering through-the-line solutions through-the-line to holistically solutions address to holistically the challenges address across the challenges the Production across chain, the Production Life Sciences chain, Life Sciences Industry gets the boost Industry it deserves. gets the boost it deserves.
Adherence to quality Adherence standards to across quality standards the verticals across of procurement, the verticalsmanufacturing, of procurement, packaging, manufacturing, handling, packaging, storage and handling, storage and distribution that complete distribution the that production complete cycle theisproduction a decisivecycle factorisina ensuring decisive factor qualityinoutcome. ensuring And quality in today’s outcome. highly And in today’s highly competitive environment competitive organizations environment needorganizations effective Quality need Management effective Quality Systems Management that not only Systems fuel efﬁciency that not only at each fuel efﬁciency at each level but also affect level harmony but also between affect harmony these disparate between functions these disparate to realizefunctions optimized toperformance realize optimized & proﬁtability. performance & proﬁtability.
PPro from Motto GMPPro Systems from is Motto a worldSystems class quality is a world & compliance class quality management & compliance system management speciﬁcallysystem tailoredspeciﬁcally to meet the tailored to meet the ds of Life Sciences needs Industry. of Life Sciences With a host Industry. of inherent With a advantages host of inherent associated advantages with it,associated GMPPro iswith enabling it, GMPPro Pharma is enabling Pharma anizations of allorganizations sizes to streamline of all sizes their to quality streamline processes, their quality eliminate processes, redundant eliminate systemsredundant and reduce systems humanand intervention reduce human intervention iscover attain new to discover levels ofattain excellence. new levels of excellence.
MPPROGMPPRO ADVANTAGES ADVANTAGES
obust & Scalable » Robust Procedures & Scalable Procedures
Timely updates »& Version Timely updates controls& Version controls
onsistent Performance » Consistent Performance
Better Visibility on » Better Workloads Visibility on Workloads
asy to Access » & Easy Easyto toAdopt Access & Easy to Adopt
Efﬁcient Work Planning » Efﬁcient & Management Work Planning & Management
ontrol over Non-Conformances » Control over Non-Conformances
Streamlined Work » Streamlined Approach Work Approach
PHARMACEUTICALS PHARMACEUTICALS NUTRACEUTICALS NUTRACEUTICALS BULK BULK DRUG DRUG ANALYTICAL ANALYTICAL BIOTECHNOLOGY BIOTECHNOLOGY
MPPROGMPPRO & HOW IT&HELPS? HOW IT HELPS?
dds value to »the Adds organization value to the in terms organization of quality in terms» of Real quality time visibility » Real in operations time visibility keeps in management operations keeps in management in
ompliance by making compliance every user by making to follow every SOPs. user to follow SOPs. the know on actualthe statuses. know on actual statuses.
elf-guiding procedures » Self-guiding that help procedures employees thattohelp follow employees » Diverse to follow utility; with » Diverse GMPPro utility; ﬁnding withapplicability GMPPro ﬁnding acrossapplicability across
ood documentation good practices documentation every time. practices every time.
the spheres of Material the spheres management, of Material Manufacturing, management, Manufacturing,
Quality Control, Quality Quality Assurance Control, Quality and Engineering Assurance and Engineering acked by GMPPro » Backed software by GMPPro that eliminates softwaretedious that eliminates tedious requirements. requirements. manual documentation manual while documentation making it error while free. making it error free.
» Most cost-effective » Most solution cost-effective in its class solution that goes in its onclass to that goes on to esigned to be»user-friendly Designed toand be user-friendly easy to understand and easy to understand be a proﬁtable investment be a proﬁtable in the long investment run. in the long run. where minimum functional where minimum knowledge functional of production knowledge of production
more... And many more... rocesses is sufﬁcient processes for isemployees sufﬁcient to for handle employees And to many handle
Insightful and all-embracing
Backed by a thorough understanding of each functional area of the production spectrum GMPPro by Motto Systems is smartly devised solution where the robust independent modules of each domain like warehouse, production, quality control, quality assurance and engineering can be seamlessly integrated to meet more than one requirement upon demand.
WAREHOUSE » » » » » » » » » » » » » » » » »
Material Plan Purchase Enquiry Purchase Requisition Purchase Order Material Receipts Mixed / Tanker Solvents Job Work Process Inter unit Transfers Material Inventory Material Gatepass Material Request & Release Marketing Indents Sales Orders Dispatch Advice Product Dispatch Supplier Management Customer History
» » » » » » » » » » » » » » » » » »
Speciﬁcations Sample Inward Sample Analysis Raw Data Management Reserve Samples In-house Working Standards Reference Standards Volumetric Solutions Lab Chemicals Out Of Speciﬁcations (OOS) OOS Manufacturing Investigation Out Of Trends (OOT) Stability Protocols & Process Certiﬁcate Of Analysis (COA) Re-test Analysis Instrument Calibration & Reports Third Party Testing Samples Samples Destruction
PRODUCTION » » » » » » » » » » » » »
QUALITY ASSURANCE » » » » » » » » » » » » »
Production Plan Bill of Materials Batch Indents Batch Line Clearance Equipment Line Clearance Batch Process Records BPR Request & Issue Batch Execution Recovery & Reprocess Material Transfers Commercial Packing Dispatch Advice Equipment Logs
ENGINEERING » » » » » » » » » »
Equipments Instruments Calibrations Preventive Maintenance General Maintenance Service Request Breakdown Maintenance Equipment Occupancy Work Permits IQ, OQ & PQ Documents
QA Release Change Control Deviations & Investigation Incidents Document Control Supplier Qualiﬁcation Complaints Product Returns Product Recall CAPA Management Quality Review Yield Review Electronic Document Management
ENGINEERING SERVICES QUALITY ASSURANCE
PLANNING & PROCUREMENT
QUALITY CONTROL MATERIAL MANAGEMENT PRODUCTION
Specific needs. Specific Solutions!
GMPPro Solutions are designed to offer flexibility of choice to the clients. An independent module to meet a speciﬁc requirement or the full scale application to address issues comprehensively, GMPPro Solutions caters to clients’ needs with judiciously crafted solutions.
With seamless integration of processes across production chain, our clients can expect enhanced performance in terms of quality and productivity.
GMPPro – 360
GMPPro – QMS Prioritizing quality!
Built-to-suit to your requirements
GMPPro – 360 is a full scale enterprise solution to cater the needs of complete process life cycle management right from Procurement, Process, Quality and Delivery.
GMPPro – QMS is an Enterprise Quality Management system (EQMS) designed to take care of complete Quality needs of a company with Quality Control (LIMS) and Quality Assurance modules.
With GMPPro – Modular, clients can enjoy the advantages of GMPPro by getting customized solutions with full functional scope to meet speciﬁc requirements of the organization.
The one stop solution!
GMPPro – Modular
WHY CHOOSE WHY CHOOSE GMPPRO? GMPPRO?
GMPPro inspires enhanced Quality practices thepractices ground up. Designed with up. a deeper understanding of processes, GMPPro inspires enhancedfrom Quality from the ground Designed with a deeper understanding of proces GMPPro greatly aids the users in aids adhering to theinstandards uniquelywhile conﬁgured built-inconﬁgured cGMP functions GMPPro greatly the users adhering while to thethe standards the uniquely built-in cGMP funct facilitate effective facilitate control over operational deviations and non-conformities. The advantages inThe a nutshell effective controllimitations, over operational limitations, deviations and non-conformities. advantages in a nuts include: include:
Industry Best Practices: Motto Systems’ prides on a perceptive approach to its work that realizes error free, stringent and easy to
Industry Best Practices:
implement Quality Management Systems every time. The team of qualiﬁed subject matter experts at Motto Motto Systems’ prides on a perceptive approach to its work that Systems’ interacts with personnel of relevant departments before setting out to design systems that augment realizes error free, stringent and easy to implement Quality best practices at all levels. Management Systems every time. The team of qualiﬁed subject matter experts at Motto Systems’ interacts with personnel of relevant departments before setting out to design systems that Controlled Environment: augment best practices at allwhere levels. GMPPro ushers stringent compliance regimes deviations from Standard Operating Procedures become almost extinct. It lends control over document distribution and access, enables supplier control through effective evaluation and effectively reigns in rejections and non-conformities to catalyze overall proﬁtability of the organization.
GMPPro ushers stringent compliance regimes where deviations from Standard Operating Procedures become almost extinct. It
Connected Processes: lends control over document distribution and access, enables
Motto Systems’ appreciates the through need foreffective effective coordination and communication at Inter and Intra supplier control evaluation and effectively reigns department levels in forrejections realizing overall efﬁciency. GMPPro achieves this by bringing various functions on to one and non-conformities to catalyze overall proﬁtability integrated platform while eliminating silos between departments and the ensuing data duplication for of the organization. improved data integrity.
Connected Processes: Improved Compliance:
Motto Systems’ appreciates the need for effective coordination GMPPro works intelligently for data delegations and validations. By reducing manual dependencies it and communication at Inter and Intra department levels for improves ease of data administration during investigations, review, analysis & trending of data. realizing overall efﬁciency. GMPPro achieves this by bringing various functions on to one integrated platform while eliminating
Cost Reduction: silos between departments and the ensuing data duplication for
GMPPro saves great in termsdata of both money and time. Not only it disposes off with the onerous manual entries improved integrity. but also acts as your ready reckoner during data veriﬁcation & reporting in addition to facilitating timely delivery to customers. Not to mention the cost of production reruns in case of non-compliance to procedures.
Improved Compliance: GMPPro works intelligently for data delegations and validations. By reducing manual dependencies it improves ease of data administration during investigations, review, analysis & trending of data.
Cost Reduction: GMPPro saves great in terms of both money and time. Not only it disposes off with the onerous manual entries but also acts as your ready reckoner during data veriﬁcation & reporting in addition to facilitating timely delivery to customers. Not to mention the cost of production reruns in case of non-compliance to procedures.
Motto Systems emphasizes Motto Systems onemphasizes providing on providing futuristic solutions that inspire HE QUALITY THE ADVANTAGE QUALITY ADVANTAGE futuristic solutions quality thatatinspire every level quality of the at production cycle. N YOUR SIDE! ON YOUR SIDE! every level of the production cycle.
Our capabilities Your competency
Our capabilities Your competency
CORE CAPABILITIES »
21 CFR Part 11 compliance for Electronic Records &
Drill-down data architecture for effective investigations.
Harmonized best practices and guides users to follow
21 CFR Part 210 & 211 compliance for cGMP Practices.
Customizable workflows as per company SOPs.
» Built-in cGMPs to achieve compliance at every level. ORE CAPABILITIES
as per SOPs.
Advanced search options and retrieval of intended data. Complete control on rejected & expired materials for usage.
» Automated Notiﬁcations via dashboard widgets and 1 CFR Part 11 compliance for Electronic Records & » Drill-down data »architecture for effective Version controls and investigations. access controls over obsolete emails. Signatures. documents. » Harmonized best practices and guides users to follow » Auto escalation of tasks, reports and complaints. 1 CFR Part 210 & 211 compliance for cGMP Practices. as per SOPs. » Complete data security & automated data backup. » Integrated change management throughout process Customizable workflows » Advanced search and retrieval » options Complete Audit Trail.of intended data. cycle. as per company SOPs.
Built-in cGMPs to compliance at and every level. » Complete control on rejected & expired materials for » achieve Self-driven navigation user friendly screens.
usage. Automated Notiﬁcations via role dashboard widgets » Secure and based access to and each module. » Version controls and access controls over obsolete mails.
Auto escalation of tasks, reports and complaints.
ntegrated change management throughout process
Self-driven navigation and user friendly screens.
Secure and role based access to each module.
Complete data security & automated data backup.
Complete Audit Trail.
GMPPro IMPLEMENTATION PLAN Business Process Study & Gap analysis
Trial installation & Preliminary Training Customization & End User Reports
GMPPro installation & User Acceptance Testing End User Training
Pre-Production Validation & Go Live
During the course of implementation and support, we found Motto Systems is committed and delivered best quality. We are happy to recommend M/s. Motto Systems Pvt Ltd., for any one whom so ever interested in implementing GMPPro for their business.
About Motto Systems Motto Systems’ is an organization that has made pioneering strides in providing top-class Enterprise Quality Management Solutions (EQMS) to Life Sciences’ companies. Driven by innovation and backed by a qualiﬁed team of GMP domain and IT experts, Motto Systems’ is enabling organizations to overwhelm their pressure to remain competitive while meeting quality standards, through its range of innovative products. In addition, Motto Systems’ is inspiring companies to seamlessly achieve global regulatory and company-speciﬁc requirements with its revolutionary compliance management solutions. Motto Systems Pvt. Ltd., 1st Floor, Samridhi Vasyam, Jaihind Colony, Madhapur, Hyderabad - 500 081. TS. INDIA. | [email protected]
Mr. K. Raj Gopal +91-95 5344 4478 +91-40-2311 6886 [email protected]