Alembic wanted significant control over processes in order to achieve a ‘single source of truth’. Developing, maintaining and safeguarding highly sensitive information during development and production was the biggest priority for the company.
Adhering to global compliance requirements was important too. However, with increased regulatory scrutiny, the company faced multiple hurdles during audits. But with a structured document management system built on Microsoft SharePoint 2013 it overcame the
weaknesses of content management and gained a unified view of the entire product development lifecycle. Executives can now view, trace and access every document, increasing productivity by 40 percent. This will result in faster time-to-market in the future.
Also, by reducing its paper trails by more than 30 percent, Alembic is more environmentally responsible, and it has decreased storage space greatly.
||Document approvals and processing is completed very quickly. The cycle of one week is reduced to one to two days resulting in time savings of 50 percent, which allows us to take new drugs to market far more quickly
| Dr. Vinay Nayak
President, Technical Operations, Alembic Pharmaceuticals Ltd
Established in 1907, Alembic Pharmaceuticals is a leading pharmaceutical company. It is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and intermediates. Alembic's manufacturing
facilities are located in Vadodara, Gujarat and Baddi in Himachal Pradesh, India.
Developing, maintaining and safeguarding highly sensitive information is the key to its business. “We were using shared folders in a file server where authentication was only a password,” says Nitin Parmar, Head, IT, Alembic Pharmaceuticals Ltd. “With multiple
versions floating across the organization, at times it was difficult to identify which version we were working on.”
As the pharmaceutical business is highly regulated, adhering to global compliance requirements is also necessary. Alembic publishes information in a variety of formats, each one and its process having to meet a specific regulatory requirement. With multiple
global regulators and ever-increasing stringent protocols, this means very high time investment. Despite this, it still faced complications during audits. “We submitted signed, printed copies for the audit but, because of the system limitations, even though
we had the right answers, we were unable to present the justification accurately,” says Dr. Rajiv Desai, Senior Vice President, Quality Operations, Alembic Pharmaceuticals Ltd.
The problems compounded over time, as documents were often saved to desktops, and there were no consolidated reports. Consequently, identifying the right data at the right time was challenging.
To maintain its reputation, Alembic wanted a more holistic approach to improve business processes. “We needed an efficient document management system that followed the latest regulations on security,” says Nitin. “We realized that it would help us be more
efficient, increase document quality and decrease costs.”
After evaluating multiple solutions over six months, Alembic finally made the decision to implement Microsoft SharePoint 2013. “We wanted a solution that required minimal customization and met all our expectations,” says Nitin. “Microsoft SharePoint 2013
had all the capabilities we needed. And, it offered much more than just document management. Plus, SharePoint interoperates with our existing line-of-business solutions, such as SAP ERP.” Alembic needed a local partner that could help with the implementation.
It brought in Bitscape Infotech, a Microsoft Partner that specializes in Microsoft SharePoint-based solutions. With previous track records of working with pharmaceuticals companies for SharePoint deployment, Bitscape Infotech already had a framework, Bitscape
Vault, for industry compliances on SharePoint. However, instead of multiple solutions to satisfy compliance requirements of multiple countries, Alembic opted for a comprehensive solution that could fulfil these needs.
Controlled Document Management System
||With the search capabilities of SharePoint 2013, I can easily find what I need. I know it is the right version. Quick retrieval of data has increased our productivity by 40 percent
| Dr. Rajiv Desai
Senior Vice President, Quality Operations, Alembic Pharmaceuticals Ltd
The document management system enables Alembic to establish and maintain a ‘single source of truth’ for its content. It employs SharePoint workflows, life cycle management and search functionality. Dr Desai explains, “Before we create a master document,
it goes through multiple reviews and approvals. Automated workflows ensure that tasks are completed by their due dates. Therefore, workflows are very important and essential for our Quality department. They provide the facility to store a document in a controlled
way, improve efficiency, and dramatically reduced our time spent managing projects.”
Overall control of the documents and content management is perfect in SharePoint 2013. “It gives us a solution where not only can I control the document version but the printing and reviewing mechanism gives me the right perspective that whatever I am referring
to or printing is the latest version,” says Chital Patel, CQA, Alembic Pharmaceuticals Ltd. “I am confident about the availability of data. I am able to search and identify the right data at the right time.”
Chital Patel says, “With the new solution, we are more disciplined. Earlier we used to take the liberty of doing documentation after the fact. Now, it is necessary that we finish documentation on time. It gives visibility throughout the manufacturing process,
and ensures that we follow the correct processes that drive efficiency and accuracy across the organization.”
Documentation distribution has become very easy. Employees no longer have to send each document through email or as a physical hard copy. Now it is available at a single location and users are able to access, review, view and print it.
“Previously, there was no central information source. With multiple data sources, it was hard to get an accurate picture of the data. The implementation of SharePoint not only helps us ensure that we have the information we need but also ensures compliances
are met as required. It serves as a centralized platform for our new IT governance needs and controls, and provides us a 360-degree view of data,” says Dr. Vinay Nayak, President, Technical Operations, Alembic Pharmaceuticals Ltd.
Addressing Security Concerns
Intellectual property rights are very important in the pharmaceutical business. Alembic applies for over 12 to 15 patents each year. Securing this information is therefore paramount.
Implementing SharePoint 2013 is the first step towards having a controlled and secure environment. Alembic is also evaluating the implementation of Microsoft Exchange Server 2013 and Microsoft Lync Server 2013 in the near future.
||Microsoft SharePoint 2013 is a platform on which we have begun our journey with a document management system. We are expecting many more compliance driven applications to be built on the same platform using its smart features
| Nitin Parmar
Head, IT, Alembic Pharmaceuticals Ltd
By adopting SharePoint 2013, Alembic is benefiting from a powerful document management system. The innovative solution improves productivity, reduces costs and drives a competitive advantage. “Microsoft SharePoint 2013 is a platform on which we have begun
our journey with a document management system,” says Nitin. “We are expecting many more compliance driven applications to be built on the same platform using its smart features.”
Reduces Time-to -Market
Bringing a new drug to the market is a long, arduous and expensive process. During the entire product lifecycle from product inception to phase out, Alembic creates reviews, approves and manages approximately 3,00,000 documents annually. Says Dr. Nayak,
“Document approvals and processing is completed very quickly. The cycle of one week is reduced to one to two days, resulting in time savings of 50 percent, which allows us to take new drugs to market far more quickly.”
Improves Operations, Regulatory Compliance
With the new solution in place, all Alembic departments are now integrated with each other. Starting from procurement to dispatch, the entire cycle is integrated.
The solution follows the 21 CFR guidelines.
Now the company is confident of facing any kind of audit questions. Dr. Desai says, “As management, we have a clear understanding of the complete process. We are able to show our auditors the entire journey of the document on our system. It is easy for us
to convince them and provide justification. SharePoint 2013 is accepted worldwide and auditors know that we cannot modify documents without authorization. Everything is system driven, giving us complete control and audit trails for each and every activity.”
Increases Productivity by 40 Percent
With SharePoint 2013, employees work together, share documents, and visualize data and access resources. All information is available at a single central location, which makes it easier to update, search and retrieve it. “I no longer have to go through piles
of paper or emails to find information,” says Dr. Desai. “With the search capabilities of SharePoint 2013, I can easily find what I need. I know it is the right version. Quick retrieval of data has increased our productivity by 40 percent.”
Reduces Paper Consumption and
Traditionally, Alembic used to produce and store large amounts of information across departments. For all audit purposes, the company was keeping physical hard copies of documents. It was not only wastage of stationery but also of time and effort spent to
print these documents. One of the main reasons for implementing a document management system was the reduction in the amount of paper and forms that were being manually pushed from person to person.
Nitin explains, “On an average, we were making six copies of each document for audit requirements. Moving away from manual based systems helped us reduce paper consumption. In addition, it enabled us to reduce our storage needs, leading to huge savings in
storage costs. In a way, it is an effort on our part to ’go green‘and be more environmentally responsible.”
SharePoint is the new way to work together. A simplified user experience helps you organize, sync, and share all your content. New social capabilities make it easy to share ideas, keep track of what your colleagues are working on, and discover experts you
never knew existed.
For more information go to:
About Bitscape Infotech
Bitscape is a2013 Microsoft World Wide Partner award finalist for BI and a Microsoft technology focused solutions partner specializing in Microsoft SharePoint technologies and Windows Azure based development services. It has vast experience in delivering
solutions and services using Office365 and workflow management solutions. It also offers seamless migration services from on premise Exchange and SharePoint to Office365 based SharePoint Online and Exchange Online. It is an ISO 9001, ISO 27001 and ISO 20000
certified business and technology consulting company. Bitscape has multiple Microsoft competencies at the organizational level.
To know more about current competencies and offerings of Bitscape please visit MicrosoftPinpoint profile
For More Information
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For more information about Alembic Pharmaceuticals Limited products and services, visit the website at:www.alembic-india.com
For more information about Bitscape Infotech products and services, visit the website at:www.bitscape.com
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