Streamlining

Compliance

www.manucomply.com

A Case Study

Successful SaaS Adoption

in the Pharmaceutical

Industry

About the Client

This case study examines the successful implementation of the Manucomply

Compliance Management Tool by a Global Pharmaceutical Company. Before

implementing Manucomply, the company managed compliances manually which was

time-consuming and labor-intensive.

Ensuring compliance in a constantly evolving and dynamic landscape demands vigilant

and continuous monitoring. In the pharmaceutical industry, this is especially crucial due

to the severe consequences of any lapses.

Regulations ensure the safety, efficacy, and quality of drugs, protecting patient health

and public safety. Maintaining compliance not only fosters trust with regulatory bodies,

healthcare professionals, and consumers but also helps avoid legal penalties and costly

recalls. Additionally, it ensures ethical business practices, safeguarding the company’s

reputation and market position.

The client, a global pharmaceutical giant, operates across multiple sectors and

geographical locations. Their R&D division, staffed by over a thousand scientists, is

renowned for developing biosimilars, sophisticated APIs, novel drug delivery systems,

new chemical entities, and specialized generics.

The company operates 98 divisions and subsidiaries , has over 250 branches and

business units, and the client faced significant challenges in managing over 40,000

compliances annually.

Compliance Management Challenges

Posed by Manual Processes

Managing a large organization with multiple industry

sectors and units presented difficulties in

monitoring and ensuring compliance, given the

complexity and diversity of operations.

The organization lacked a comprehensive

compliance database, which hindered its ability to

ensure the completeness of all legal requirements

across its various units and industry sectors.

Navigating a vast web of compliance obligations,

encompassing multiple regulators, stakeholders,

and a multitude of legislations, rules, and

regulations was a significant challenge.

Compliance was manually managed using

spreadsheets and emails, leading to the

accumulation of a large number of documents

dispersed across multiple machines and individuals.

This made it difficult to maintain and track

compliance documents, ensuring that all necessary

records were up-to-date and easily accessible.

The manual system did not provide for any kind of

alert or reminders for upcoming compliance due

dates, increasing the risk of missed deadlines and

non-compliance. There was no effective

mechanism for presenting compliance status data

to top management, hindering their ability to make

informed decisions and take timely actions.

Due to the lack of visibility, it was difficult for senior

management to track and monitor compliance

effectively, leading to potential oversights and

penalties. This also resulted in time-consuming and

unreliable manual reporting.

The manual process resulted in low transparency

and a lack of ownership or awareness among the

team about compliance requirements. This lack of

clarity extended to who was responsible for what,

further complicating the compliance management

process

0605

The dashboard has transformed compliance

management by providing a centralized,

accessible, and efficient system.

This includes real-time visibility of the status of

mapped compliances, internal operations, audit

reports, and compliance certificates, accessible

anytime and anywhere.

The Power of a Smart Dashboard

The Admin user can access all information on their dashboard with a single click, eliminating

the need for sending chains of emails and calls and waiting for updates.

The decision-maker has a comprehensive view of the dashboard, allowing them to directly

assign or reassign compliances to relevant users as needed.

The color-coded, graphical representation significantly enhances clarity and facilitates

quick understanding.

The ability to configure fields according to user requirements has greatly enhanced user-

friendliness, allowing users to select and view the most relevant data.

Timely Alerts and Notifications:

Automated reminders ensure that users

are always informed about upcoming

compliance deadlines and regulatory

changes. This proactive approach helps

them stay ahead of requirements.

Easy-to-Read Timelines and Calendars:

Visual tools such as timelines and

calendars make it simple to track and

prepare for compliance deadlines,

ensuring that users never miss a critical

date.

Task Management: Timely reminders help ensure that tasks are completed on schedule,

minimizing the risk of penalties and maintaining continuous compliance.

Automated Alerts, Reminders & Notifications

Streamlining Compliance Management

with Manucomply

Centralized Document Management for Efficient Oversight

A centralized repository for all compliance-related documents covering obligations from

multiple regulators, stakeholders, and numerous legislations, rules, and regulations was created.

This repository ensures that all statutory compliance documents, policies, forms,

applications, certificates, penalty communications, and previous year returns are stored in

one place.

This single source of truth facilitates easy access and retrieval, supporting comprehensive

compliance oversight.

With previous year compliances migrated to the Manucomply tool, a unified source for both

past and ongoing compliances was created.

This significantly reduced coordination efforts and save valuable time in the process.

The tool makes it easy to manage receipts and acknowledgement slips for challans and

returns all in one place.

With Manucomply, users no longer have to spend hours searching for legal updates. The tool

automatically tracks and integrates all relevant legal updates affecting the business, providing

both old and current versions for easy comparison. This seamless integration saves time and

effort, ensuring everyone stays informed and ahead of regulatory changes effortlessly.

A Comprehensive Overview of the

Process

Discovering the Scope and Business Activities

Compliance and Risk Assessment

Manucomply adopts a collaborative approach right from the start to understand the

business and industry requirements, assess relevant regulations and laws, and engage with

key stakeholders. This involves utilizing questionnaires, discussions, and meetings with

relevant groups.

Manucomply’s team conducted a thorough research to build a comprehensive database

identifying specific regulators, regulations, legislations , authorities and bodies relevant to

the clients operations.

Our procedure included the following steps:

Replicating the organization structure of the client on the Manucomply tool . This

included mapping the Group Entities, Sub-Entities, Locations, Number and Type of

Establishments, Sector, Departments ,Users).

Creating Users, Approvers, and Admin Accounts (following the Maker-checker concept). 2.

After gaining a comprehensive understanding of the business activities, nature and location

of units and conducting in-depth discussions based on the questionnaire, we create a

detailed compliance checklist. This checklist comprises various rules, regulations, acts,

guidelines, master circulars, etc.

During our compliance and risk assessment process, our team identified that our client

operates more than 250 units across 98 companies in multiple geographical locations. This

includes over 50 manufacturing units, 50 branch offices, 50 head offices, etc., employing

around 12,000 workers, some of whom are on contractual basis, others from different states,

and some on daily wages. The client also engages multiple heavy vehicles for goods

transportation, as well as weighing scales.

300 users were created and assigned roles such as Users, Approvers, Department Heads,

Unit Heads, and Admin Accounts. 340 legislations and more than 10,000 compliances

applicable to the client were identified. These included various challans, permissions, returns,

and display compliances, some of which are required on a daily basis. The compliances

covered multiple categories.

Stage I

Stage II

The Final Stage

This stage is the most critical phase of the process, namely the implementation phase. For

the client's implementation, a team of 8 team members worked meticulously to complete the

entire implementation process.

The final stage comprises of the following steps:

Reviewing the final compliance checklists

Conducting a final review meeting with the HODs and major stakeholders to finalize

compliances.

Identifying any gaps in laws.

Adding Users , Departments and Locations

Mapping compliances to the users specified by the organizations based on their

departments and roles.

Providing comprehensive tool training to all categories of users on how to use the tool

and perform compliance.

Activating the tool.

Stage III

Phase I –

Business

Understanding

Phase III -

Tool

Implementation

Phase IV -

Mapping on the tool

Phase V

Go-Live

Phase II -

Legal & Statutory

Compliance List Finalization

Understanding the

scope, requirement

and assessing

applicability

Discussion with client on

statutory and internal

compliances and their

applicability

Previous year’s

compliances to be shared

by client.

Discussions on

department and user wise

allocation

Setting up application

& database

Data Migration

Mapping of previous

year’s data and the

current applicable

compliances

Implementing and

mapping of

compliances on

the tool to each

user

Authorizations,

Escalations

User Training

Go-Live on System

Training of users,

all stakeholders,

authorities. Sharing

of user manuals,

training material.

Periodic check in

Ongoing support

40%

Foundations for Effective Digital Adoption

Adopting SaaS can be challenging due to the need for significant changes in existing workflows and

processes. Organizations often face resistance from employees who are accustomed to traditional

methods. Data migration from legacy systems to the new platform can be complex and time

consuming. Ensuring data security and compliance with regulations adds another layer of difficulty.

Additionally, ongoing training and support are required to ensure users can effectively utilize the

new system.

The leadership recognized the long-term benefits of SaaS, such as improved scalability, reduced

operational costs, and enhanced data accessibility. By clearly communicating these advantages

and involving key stakeholders early in the process, they fostered an openness to change. Senior

executive involvement was crucial in facilitating adoption across all corporate departments,

extending beyond the typical teams. While the transition required some effort, the deployment,

training, and continuous support mechanisms ensured the successful adoption of the SaaS

solution. This proactive approach ultimately drove operational efficiency and digital innovation

within the company.

IMPROVEMENT IN

COMPLIANCE

Client Feedback

“ Manucomply has become a crucial component of our company's compliance

management system, replacing our manual methods. The structured approach

has streamlined our documentation process, consolidating all data and

compliances in one place. The email reminders for compliance due dates ensures

we are not missing on crucial deadlines. The reporting is now more objective,

supported by evidence and data, enhancing our overall compliance management.

The biggest benefit is that our teams no longer need to hunt and scour multiple

sources to stay updated. "

Request a free

Demo Now!

Reach Us Out

Digitally Transforming Compliance

Tailored for your organization and how your team works.

manucomply@manupatra.com

www.manucomly.com

91- 120-4014444, 4014433

The transformation of compliance management at our global pharmaceutical

company client through the adoption of the Manucomply Compliance

Management Tool stands as a beacon for organizations seeking to streamline their

compliance processes.

Faced with the daunting task of managing over 40,000 compliance requirements

annually, the company transitioned from a cumbersome, manual system to an

efficient, cloud-based solution. This shift not only centralized compliance

documentation and enhanced accessibility but also introduced automated alerts,

real-time visibility, and improved accountability across the board. The result was a

remarkable 40% improvement in compliance within the first year, showcasing the

powerful impact of embracing digital innovation.

This case study exemplifies how strategic technological integration can drive

operational efficiency, bolster regulatory adherence, and ultimately build a culture

of continuous improvement and transparency.

Conclusion