Drug Master Files (DMFs), also know as Active Substance Master Files (ASMFs) are documents containing important information about manufacturing facilities, production details and packaging. The Active Pharmaceutical Ingredients (APIs) department is responsible for preparing the DMFs for each drug substance.

With the introduction of Common Technical Document (CTD) for DMF submissions, efforts for preparing a DMF have been simplified. However there are still many challenges faced during the creation of DMF. Many countries still mandate for paper based copies of these DMFs. Each DMF contains almost 1000 plus pages separated into several volumes (CTD Modules). The resulting process of preparing these DMFs in the structured format, printing them in the standards as required and finally storing these documents becomes tedious and enormous.

Countries require the paper storage and DMF packaging specific to there requirements and hence each DMFs need to be addressed differently. For an instance, the United States Food and Drug Administration (FDA) requires two copies of each Type II DMF using the CTD format however they do not need it in CTD module form. Instead, they require one continuous document embracing the CTD formats without any distinction between an “Applicant Part” or “Restricted Part”. The FDA also required copies in black and red binders with updates containing only the sections changes while EU requires the entire document to be submitted again. EU which comprises of many countries within has different requirements for DMF submission. France requires a paper form as well as an electronic form while Netherlands will accept only electronic copies each in their own separate format. Canada and Australia have different DMF structures.

A pharmaceutical company needs to be lot patient in creating these DMF documents and packaging them as per the country specification. If these companies have a distributed location for departments and production it becomes even more cumbersome to compile and package the documents.

SoluSoft identified this as a pain area for Active Pharmaceutical Ingredient (API) departments and have successfully offered a Business Process Management Solution that helps in automation of creation of folder structure, uploading of documents and managing them in the central storage system [Document Management System]

BPM for API department

The client and their challenge:

The client is a pioneer in Pharmaceuticals Company with strong thrust in exports dealing with API, generics and branded formulations.

The main purpose of implementing Business Process Management for API department was to ease their task of DMF creation and management thus helping the department to be more efficient, productive and streamlined.

The client was in need of a solution that could eliminate their week long process of DMF creation and packaging for submission to a particular country.

Some of the key challenges faced by the client were:

• Creation on country specific CTD folder structure
• Scanning and preparing of documents with proper header and footer
• Placing the right version of documents into correct folder
• Maintain track of submission made to agencies along with the query response
• Easy facility to cut CDs for customers

The Solution

SoluSoft architected an easy to use DMF management solution using Solusoft Document / Content Management System.

Key SoluSoft Highlights:

• DMF documents received from location and other departments are prepared as batch in a pre defined fashion.
• Batch documents are scanned
• Custom header footer insertion on documents for proper DMF formatting.
• Indexing of documents and storing the documents into the particular folder of the CTD structure in DMF.
• 21 CFR Part 11 compliance and proper audit logs
• Version control for keeping track of latest version of DMF
• Query Response to manage communication thread with agencies

The Benefits:

SoluSoft’s solution helped the API department achieve significant and tangible & intangible benefits like:

• A weeks task of DMF creation is reduced to three days
• Automated creation of CTD structure makes it easier for use.
• Client could maintain standard formatting for all DMF.
• Client can now focus on their core business than processes
• Client can keep a track of DMF submitted to agencies
• Digitization of documents helped department overcome space and cabinet issues.
• A huge amount of backlog DMFs was cleared. DMFs created over the years were instantly digitized and stored into the system
• Quick response to queries from agencies
• The head of the department could completely monitor the processes
• Alerts and reminders for DMF submission helped the department do timely submissions.
• The client was able to maximize their relationship with their customer through significant increase in productivity, accuracy and turnaround time
• Client’s employees felt increasingly motivated as the manual tasks were replaced with more analytical activities.

About SoluSoft

SoluSoft has been pioneers of Document / Content Management and Workflow Systems since 1994. It is one of the leading Business Process Management [BPM] companies in India. SoluSoft has offices in the US and India and partners in a number of countries worldwide.  The customer driven solutions they provide enable businesses to unlock new levels of information integration, allow collaborative governance, and provide knowledge-based decision making to achieve new levels of performance.

Contact Us

Note: No part of this document may be copied, modified, deleted or expanded by any process or means without prior written permission from SoluSoft

What is a Case Report Form [CRF]?
CRF is a paper based or electronic form containing questionnaires. CRF is specifically used in Clinical Trial and Research studies. CRF is used to collect information about each participating site. Information about patients such as their demographic data, screening information, previous medical history, visit, laboratory analysis and Adverse event reports.

CRF Process
The sponsor of the clinical trial study designs the CRF to collect the specific information they need from subjects (patients) in order to test their hypotheses or answer their research questions

Once the CRF is designed and submitted, the sites fill in all the required information along with the patient information. The CRF is either electronic of paper based.

An ideal process includes

1. Scheduling of the patient and entering the pre requisite information into the document management system.
2. Registration of patient and allocation of a clinical staff (Clinical Nurse)
3. Conduct all tests and analysis on patient and store reports, prescriptions and recommendation information into the document management system by either scanning the reports or uploading the electronic copy.
4. Clinical Clerk performs the quality check on the complete CRF and finally sends it to the Clinical Doctor for expert comments and recommendations.
5. On approval from the clinical doctor, sponsors consider the CRF form valid for inclusion into the research.

CRF Check using Document Management & Workflow System

Document Management:

• Documents are stored in a document library with fields such as Study Code, Randomization Number, Study Reference Number and Study Title for easy search

• Annotations provide an interface for collaboration on the CRF documents

Process Management:

• Workflow Designer helps create custom process for reviewing the CRF by Clinical Clerk, Nurse and Doctor.

• The documents are routed through the clinical nurse to clerk for validation and finally to the doctor for study recommendations

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India Inc. comprises of about 821,212* companies in 2009 which includes governmental and private sectors. As the second** largest growing economy in the world since 2008, India is now in a marathon of being the most powerful economy of the world. A country depends on its corporate affairs to grow its economy. With globalization, companies are able to expand their base of operations, grow their workforce with minimal investments and offer services to broad range of consumers.

India Inc is rapidly gaining confidence to become giant players in globalization through international expansion. From agriculture to bollywood, from cars like Nano to IT companies like Infosys, Indian Inc is setting up as a powerhouse of next generation global economy.
As India strives towards achieving this title of powerhouse, it is a mandate that its processes are automated as well as fine tuned. Business Process Management is a systematic approach to improve an organization’s business processes. Indian Inc is in need of Business Process Automation

BPM in India

Here are few statistics of Business Process in India

• Since 1997, more than fifteen Indian companies have won the coveted Deming Prize, a prestigious Japanese prize which is a byword for excellence in quality and management.
• Indian IT industry servicing global customers has led to the adoption of SEI CMM certifications on a significant scale.
• India has the largest number of companies at Level 5,which is the highest level of CMM
• The Government of India launched the National e-Governance Plan (NeGP) [1] in 2006, with the intent of supporting a citizen-centric and business-centric environment within the country.
• Gartner Says Indian Domestic Process Management Services Market To Grow 31 Percent in 2010

India domestic process management services segment forecast to reach $683 million in 2010, a 31.1 percent increase from 2009 revenue of $521 million, according to Gartner inc ***. The market will experience steady growth through 2014 when process management services revenue in India will reach $1.6 billion.

Opportunities of BPM in India

• Process Automation for improving efficiency
  • Automate your existing organizational processes for improving efficiency.
  • Indian organizations to improve efficiencies and scale of their operations
  • Achieve faster response times which are critical in engaging the retail customer

• Scaling Operations to meet global needs
  • With globalization, processes need to be web based for faster execution
  • Robust processes and systems are required to handle the core and support operations in companies.

• Business Process outsourcing
  • With mergers and acquisitions, companies now need user friendly application for faster integration of business processes
  • With giant companies like facebook, Wikipedia, Microsoft, IBM having its helpdesks in India, business processes is outsourced and these processes needs to be managed efficiently.

• Integration of systems
  • Companies have existing ERP, SCM and CRM systems in place feel a need to integrate them for better business process management and optimization.

• Compliance and best practice
  • Indian regulated industries like banking, telecom, and insurance are increasingly facing the need to comply with regulatory compliance and guidelines in order to execute large scale domestic and international projects. This results in a need for process automation and management.

• Digitization and document management
  • With increasing document based business processes industries such as banking, telecom, insurance, healthcare and education need a Electronical Document Management System that can help digitize the documents, manage them on central systems with proper administration and archival

India Inc is in constant need of process management and optimization however the trend of BPM is slow as the definition of BPM is not well defined.

What is BPM?

Business Process Management is a proactive way of managing business processes in a department or enterprise wide to increase efficiency, productivity, innovation, customer satisfaction by automating, improving or optimizing business processes. It is used to create, enhance, monitor, analyze, control and optimize operational business processes by utilizing people, process, and technology.

Business Process Management can be used to distribute work within an organization to different work groups, where specialized processing can take place. Process Management routes data, referenced by process instances, to designated people or activities, where predefined rules are applied and actions are performed based on specified conditions.

From a business point of view, the BPM value is summed up as follows:

B: Business Value by increasing growth and bottom line profitability of an organization

P: Process Value by continuous improvement of processes to transform resources and material to excellent products and services

M: Management Value by continuous planning, improvement and measurement through collected metrics by monitoring, analysis, control, what if scenarios and optimization

Components of BPM:

A BPM suite consists of four vital components that help in gaining an advantage:

• Business Process and Rules [BPR] – an interface for modeling and executing business process and rules including workflows using BPM tools such as Microsoft Visio, Workflow Designers and Process Engines.

• Enterprise Content Management [ECM] – A system that helps manage enterprise level documents in a central storage system in a well structured format using BPM tools for scanning, indexing, document management and archiving. Documents such as images and other intellectual information are digitized and stored into the ECM with industry compliance and security.

• Collaboration Tools [CT] — A platform enabling communication and collaboration between team, departments, company and enterprise through intranet email and messaging system, discussion forums, dynamic workspace and team sites.

• Business Intelligence [BI] — Helping generate a transparent report of the productivity of the enterprise, this BPM tools enable improving efficiency of processes and achieve desirable ROI. BPM tools such as dynamic reporting and dashboards help real-time monitor of business processes, identify trends and opportunities of optimization of business processes.

BPM Applications in India

• Global360 Document centric Process Management

o Global 360′s leading integrated process and document capabilities allow you to integrate enterprise content directly into the way you do business and support the entire document lifecycle from initial creation and scanning through secure deletion.

• IBM BPM

o IBM® FileNet® Business Process Manager (BPM) manages workflow among people and systems for content and case-based processes.

o It helps organizations increase process performance, reduce cycle times and improve productivity and decision making by addressing the creation, management, and optimization of case-based processes to improve business outcomes.

• Microsoft SharePoint based BPM

o SharePoint on its own will not be an off the shelf BPM application, however it could be integrated with an application to build a BPM.

Eye-opener Revelation

With a forecast of $1.6 billion in 2014 for Business Process Management coupled with fast growing economy of India and growing needs of India Inc, it is clear that Business Process Management is the need of the decade. BPM buzz word is gaining its momentum steady and fast. India has now its own BPM vendors such as NewGen, Skelta, SoluSoft and other prominent leaders while consultancy offered on BPM by players including the large IT services like Infosys, TCS, Wipro, Satyam, HP, Accenture, IBM, SoluSoft and local firms

4 Stage Business Process Management Execution

Business Process Management should never be treated as an off the shelf application that can be designed, developed and implemented overnight.

Business Process Management is an evolution process that begins with planning and strategical organizational processes and ends with fine tune optimization of the processes to achieve better Return on Investment.

BPM tools enable organizations to manage their information / data in a organized fashion with compliance to industry standards, automate business processes which eliminate error in execution and optimization of these processes.

Execution of Business Process Management is classified in four stages as under

• Stage1: Strategize and Plan

o Understand the existing organizational process

o Analyze those processes that can be automated using BPM tools.

o Justify and set roadmaps for implementation of those process through simulation, proof of concepts, estimation of benefits anticipated by the automation

o Identify resources needs and threats involved in process automations.

o Work with Stakeholders to identify organizational goals.

• Stage 2: Assess Competencies

o Identify champions of each process and find out factors that could strengthen the cause of BPM implementation.

o Identify processes and techniques of automation based on experience

o Assess competencies that are available in both internal and external sources including infrastructure and human resources.

• Implement Business Process

o Set organizational structures based on process using tools such as Workflow / Process designers, Visio and Flow diagrams.

o Set activity and task for each account involved in the business process.

o Set roles and positions with permissions to these accounts

o Set and share goals, plan, actions and milestones with stakeholders

o Implement the action plan and provide relevant reports

• Operate and Evolve

o Strive to achieve milestones and goal’s

o Evaluate business process and success achieved against the objectives

o Identify areas that could be improved for better performance

o Optimize those areas of business processes.

o Resolve critical issues and plan subsequent optimization initiatives.

For implementation of Business Process Management, EXPERIENCE MATTERS!

Connect with SoluSoft – Masters in Business Process Automation since 1994.

SoluSoft provides proven solutions developed using our EXPERIENCE!

Email at product@solusofttech.com for free consultations.

A classic CasePoint solution for Human Resource Module

In order to use SharePoint 2010 as a part of enterprise wide BPM solution, customers must add a comprehensive SharePoint oriented business process management suite (BPMS). This approach will raise vendor license costs but will lower overall total cost of ownership (TCO) and risk. SoluSoft has been in the business of offering imaging and Business Process Solutions (BPS) since 1994. Over the years SoluSoft has offered integrated solutions to its customers. In order to address this problem, SoluSoft has selected Global360 as a BPMS and packaged an integrated BPM solution to its customers.

A classic example is using SharePoint’s collaboration feature and Global360’s BPM features to create custom webparts.

Figure 1.1 Process: The above process is designed using rich, easy to use interface of Visio that can communicate with Case360. The workflow designed using Visio can easily be uploaded into Case360.

Figure 1.2 Dashboard interface: Custom SharePoint based dashboard that integrates case manager features. SharePoint works as a portal for collaboration.

Figure 1.3 A custom dashboard on SharePoint using webparts that calls case manager Servlet for task, discussion, fields, contents and process

Figure 1.4: Custom reports generated using Sharepoint interface for work items in workflow

SoluSoft promotes Global360 to extend the capabilities of your existing Microsoft Office SharePoint Server system with the enterprise BPM capabilities.

Business Process Management using SharePoint is achieved through CasePoint solution offered by SoluSoft using SharePoint and Global 360 products.

Global 360’s product namely process360 and case360 when integrated with SharePoint extends SharePoint’s collaboration capabilities to a new level that supports business process management.

Process360 enables organizations to create, execute, and optimize business processes, powering the management of processes through their entire lifecycle.

Case360 is a seamless solution for collaborative content and process management.

CasePoint provides a fastest way to deploy complex enterprise processes, with ease of use, comprehensive features and flexibility required to optimize processes.

CasePoint Overview:

• Collaborative User Portal

CasePoint uses SharePoint User Interface for providing designers collaborative user portal with complete control over the creation of interfaces that both empower and impress end-users.

o       Rich and impressive User Interfaces

o       Quick application construction

o       Personalized dashboard for each role and application

• Quick Application Development

With case360 and process360, CasePoint offers an easy to install, use, manage and deploy BPM platform.

• • Design workflows through Visio
  • Seamless collaboration between business and IT
  • Easy to build Business process and rules

• Structured Content Management

With case360 and Microsoft SharePoint’s power of document management, one can manage enterprise contents and documents in a structured format.

• • Well defined document templates with index attributes
  • Pre defined folder structure creation on a click of button
  • Validation and check list for proper content management

• Rich Reporting

With Global360 and SharePoint’s reporting features, rich reporting through charts and grid reports can be generated.

• • Optimize business process through report analysis
  • Visual impressive charts for easy understanding
  • A rich set of visualizations such as charts, gauges, maps, data grids and other controls.

• Content Management
  • Manage documents and contents using Case360 that provides a robust platform with access control security, version, index and search.
  • Manage your information in a structured format.

• Process
  • Implement enterprise wide process through easy to use Visio workflow designer provided by case360.
  • Automate your business process for faster and efficient execution.

• Rules
  • Define rules for each of your activities.
  • Automate and enforce policies which are centrally managed by rules engine.

• Data & integration
  • Connect data sources and integrate quickly using standard SOA development architecture.

• Portals and Forum
  • Use SharePoint features to build corporate portals and forums with rich user interface, custom dashboards that enable collaboration and efficient work completion.
• Collaboration
  • Collaborate with team members associated in processes through SharePoint’s powerful collaborative interface.
  • Use case manager discussion boards in SharePoint webparts, share content across all users.

• Webparts and user integration
  • Create impressive user interface using SharePoint.
  • Get case360 process, task, folder contents, discussions and other features in webparts under a single roof.

• Reporting
  • Real time process monitoring through rich reporting dashboards.
  • Measure productivity of the enterprise

• Optimization
  • Identify bottlenecks, improve processes and increase efficiency.
  • Find ways to improve ROI and organizational profits.

According to Forrester Research¹, Despite Microsoft’s best attempts to position the SharePoint platform for content and collaboration, many people still see it as a business process management (BPM) platform. The process management features of SharePoint 2010 are better than MOSS 2007, but they’re more limited than most modern BPM suites.

What is BPM?

David W. McCoy. Managing VP Garnet, defines BPM as …a structured approach employing methods, policies, metrics, management practices and software tools to manage and continuously optimize an organization’s activities and processes.

Business Process Management is a proactive way of managing business processes in a department or enterprise wide to increase efficiency, productivity, innovation, customer satisfaction by automating, improving or optimizing business processes. It is used to create, enhance, monitor, analyze, control and optimize operational business processes by utilizing people, process, and technology.

Business Process Management can be used to distribute work within an organization to different work groups, where specialized processing can take place. Process Management routes data, referenced by process instances, to designated people or activities, where predefined rules are applied and actions are performed based on specified conditions.

A BPM suite consists of four vital components

• Business Process and Rules [BPR] – An interface for modeling and executing business process and rules including workflows using BPM tools such as Microsoft Visio, Workflow Designers and Process Engines. BPM tools help simulate business processes and improve them at each stage of the process.

• Enterprise Content Management [ECM] – A system that helps manage enterprise level documents in a central storage system in a well structured format using BPM tools for scanning, indexing, document management and archiving. Documents such as images and other intellectual information are digitized and stored into the ECM with industry compliance and security.

• Collaboration Tools [CT] — A platform enabling communication and collaboration between team, departments, company and enterprise through intranet email and messaging system, discussion forums, dynamic workspace and team sites.

• Business Intelligence [BI] — BI tools generate transparent reporting of the productivity of the enterprise. This BPM tool enables improving efficiency of processes and achieves desirable ROI. BPM tools such as dynamic reporting and dashboards help monitor real-time  business processes, identify trends and opportunities for optimization of business processes.

What is workflow?

A workflow is a sequence of connected steps which are often known as activity. It is a representation of sequence of operations that are declared as work for a person, team, organization or an enterprise. These operations are part of a process. An Enterprises consists of  sequence of simple and complex processes.

Workflow is a type of process flow management technology that links people and software systems. This technology has been around for over 2 decades and has constantly evolved over the years to benefit automation of processes within an organization.

Components of a workflow include:

• Workflow Designer

A workflow Designer helps in designing the workflow and a rules engine add rules to each activity in the workflow

• Nodes and Transitions

It consists of nodes and transitions which have following actions:

- Automatic Process such as process, reports, task, workflow and actions on a document

- User Action – Form based action

- Set Variables- setting a value

- User Choice – selection process

- Wait – start and end activity

• Approvals

Allowing users, group, or an organization to approve based on a pre defined hierarchy in the system.

• Priority, Escalation and Alerts

Define priority based on customer support, send alerts to the workflow responsible users and escalate to other people responsible in case of delay.

SharePoint 2010 – What is it all about?

Gartner has its key findings on SharePoint 2010 as below³

• SharePoint 2010 remains a horizontal content management offering. Microsoft does not appear to be targeting vertical applications or transactional (fixed) content management with this release, but rather more collaborative processes and dynamic content applications.
• This release promises improved scalability and better support for broad enterprise deployments.
• Enterprises will be better able to govern their SharePoint deployments if new features, such as policy-based information management, prove robust and effective.
• SharePoint 2010 provides a more intuitive user interface. The range of information workers who can consume and use content management therefore continues to increase, blurring more completely the distinction between user and administrator.

SharePoint has been widely been used in

• Enterprise Document Management and Content Management
• Application Management / Portals
• Information Collaboration
• Document-based Workflow

Business Process Management is an enhanced extension of workflow. A company that has already invested in SharePoint can easily have a BPM suite in place by integrating SharePoint with a BPM vendor. A good BPM Suite available in the market would always provide a feature to enable integration with Microsoft SharePoint. Being able to connect with SharePoint workflows, documents in repositories, and information from SharePoint Team Sites in a BPMS will allow you to take your invested information to next level.

CasePoint – BPM using SharePoint and Global 360

SoluSoft promotes Global360 to extend the capabilities of your existing Microsoft Office SharePoint Server system with the enterprise BPM capabilities.

Business Process Management using SharePoint is achieved through CasePoint solution offered by SoluSoft using SharePoint and Global 360 products.

Global 360’s product namely process360 and case360 when integrated with SharePoint extends SharePoint’s collaboration capabilities to a new level that supports business process management.

Process360 enables organizations to create, execute, and optimize business processes, powering the management of processes through their entire lifecycle.

Case360 is a seamless solution for collaborative content and process management.

CasePoint provides a fastest way to deploy complex enterprise processes, with ease of use, comprehensive features and flexibility required to optimize processes.

CasePoint Overview:

• Collaborative User Portal

CasePoint uses SharePoint User Interface for providing designers collaborative user portal with complete control over the creation of interfaces that both empower and impress end-users.

• • Rich and impressive User Interfaces
  • Quick application construction
  • Personalized dashboard for each role and application

• Quick Application Development

With case360 and process360, CasePoint offers an easy to install, use, manage and deploy BPM platform.

• • Design workflows through Visio
  • Seamless collaboration between business and IT
  • Easy to build Business process and rules

• Structured Content Management

With case360 and Microsoft SharePoint’s power of document management, one can manage enterprise contents and documents in a structured format.

• • Well defined document templates with index attributes
  • Pre defined folder structure creation on a click of button
  • Validation and check list for proper content management

• Rich Reporting

With Global360 and SharePoint’s reporting features, rich reporting through charts and grid reports can be generated.

• • Optimize business process through report analysis
  • Visual impressive charts for easy understanding
  • A rich set of visualizations such as charts, gauges, maps, data grids and other controls.