How Dr. Reddy's Formula Cut Down on Product Commercialization

Dr. Reddy's Laboratories, Inc. (DRL) is a global pharmaceutical company committed to providing affordable and innovative medicines for healthier lives. Kimberly Mills, associate director, packaging development and design, works for Dr. Reddy's Laboratories' North American Generics OTC Division located in Bridgewater, New Jersey.

The OTC division launched five years ago and has seen tremendous growth in that short period of time. Because of its rapid growth they have also experienced some growing pains, which is natural for a company at its stage of growth. Manual, paper-based processes needed to be transitioned to electronic systems to support future growth and business. Mills was tasked with the responsibility of finding the best workflow automation solution to meet DRL's current and future requirements.

"It was absolutely critical that we convert our workflows and processes to an electronic system to support our skyrocketing business growth," said Mills. "We have multiple business partners in various locations, multiple plants, and remote employees, so traditional paper-based operations have definitely become outdated, challenging and time consuming. We needed a software solution that could manage all of this, with optimized workflows, automated artwork proofing, electronic project management, document lifecycle management, bills of material management, and more, and we needed it ASAP. In addition the new system, when implemented, will be fully validated and will comply with 21CFR Part 11."

Dr. Reddy's did an extensive search to find the right solution and after conducting product reviews, narrowed its selection to three different systems (a product lifecycle management product, a graphic management product, and Persistent Systems' PaxPharma, a compliance-based, design-to-print (D2P)/business process automation platform.

"The decision making process was collective. We made a concerted effort to show the systems to our users multiple times to ensure they understood each system's capabilities and were able to relate their processes to those capabilities. We got tons of good feedback from the team that also helped us sell the concept of automation within DRL," said Mills. "We formed a core team for the evaluation process with key representation from each department. We also involved our business partners—contract manufacturers, component suppliers, and display houses right from the beginning. We showed them what we were looking at and asked for their input. In the end, we selected PaxPharma over the other solutions because of Persistent Systems' extensive experience in enterprise artwork and BPA. PaxPharma also had the highest ROI compared to the other products."

Reduced project management

Before PaxPharma, DRL project managers tracked down information from one person to the next or would physically try and get four or five people in a room to resolve an issue or get project status. With the implementation of PaxPharma, all project management related information is readily available, in real-time, and the project manager has complete visibility of the project—what stage the project is in; who has done what, when; which tasks are pending, with whom and why. Project managers can now manage on exceptions, based on alerts triggered by the system on preset parameters. "The system manages the workflows so you don't need to chase anyone to see where they are in the project or if they completed their task—everything is centralized and you get a notification when something is done so you know when to execute your next task. You don't have to guess when it's going to show up on your desk, you know when you are going to get it, and you get notification that everything is complete," says Mills.

Stakeholders collaboration

Features such as online, multi-party, document and artwork proofing, audit trails, and instant messaging can be stored and searched, making collaboration across stakeholders a lot easier and effective. "Our project managers can have four to five people comment and interact on an art review in real-time, send off questions or information through the system without needing to track people down, approve art from the system, and directly send it to the appropriate vendors automatically. This dramatically improves our effectiveness, and helps reduce errors from manual interventions," adds Mills.

Centralized data

Information centralization and digitization is key to Dr. Reddy's business strategy. "We spent a lot of time tracking down data either for a project or for supporting decisions for past projects. One of the benefits we get from PaxPharma is a centralized data management system that catalogs all data and files, and is searchable by all users. The system maintains all previous versions of files with all reviews, comments, and decisions, so we can go back in time and see how the decision making evolved and why. All data from the process flows are saved automatically in the central content management system, which has all necessary access level controls and security policies that comply with DRL's security standards."

Automated proofing

Dr. Reddy's was also interested in document and artwork proofing capabilities. "We relied on the human eye to review and proof documents—manuscripts, artwork, and patient information leaflets," said Mills. "With PaxPharma, a lot of this can be automated. It has built-in intelligent proofing capabilities that can find differences between heterogeneous document types helping improve efficiencies and reduce errors. We can have real-time, interactive proofing sessions across users on the same document, all of which is saved automatically. The FDA requires us to maintain records of all changes made and PaxPharma enables us to comply with that requirement in an automated fashion."

Automated document publishing

Being in the generics business, Dr.Reddy'a has to submit documents to the FDA in certain formats—such as a 3-way compare document that compares manuscripts with that of the innovator's. "Manual creation of the 3-way comparison document is hugely time consuming. PaxPharma automatically creates the document in the format and style that the FDA requires, helping us reduce cost, time, and errors," explains Mills.

FDA label rules databases

For the OTC business, there are very clear rules laid down by the FDA—what to say on the package, and how and where to say it. PaxPharma's FDA label rules module has codified many of the FDA rules for OTC products, enabling better compliance with the rules. "We can add to the rules database, and create templates across DRL, to help ensure standardization across our products," says Mills.

New product development

A longer-term benefit of PaxPharma has to do with Dr. Reddy's new product development. Two years from now, Mills knows that because of BOM/SKU automation she can go back on an SKU and trace its history to the initial assessment done for costing and tap the lifecycle of every SKU they offer for sale or have considered offering. "I can go back and look at things we evaluated and decided not to go with—and if it comes up a year later—say, here's what we looked at; here's how it was configured at the time; here's why we decided not to go with it; do we want to change the configuration to make it optimal; have market conditions changed; do we want to change the offering? I won't be starting from scratch; I'll be pulling up past work and building on that instead of starting over."

Reduced cycle time

"With the work we've done with PaxPharma and systems process optimization we've been able to cut our business process mapping cycle time in literally half, and we expect we'll be able to easily double our business SKUs without adding more employees. With a paper-based system, we had a one-to-one ratio; one person can only handle X number of projects. With PaxPharma's automation and simplification of our processes, we're able to handle much more volume with the same amount of people. As we're in a strong business growth mode, this is really important for us and the company's plan for the future. We don't want to continually add people to take on more business; we want to be able to handle it with our existing resources. At some point we'll need to add people, but we don't want to do that just because we're chasing paper around," says Mills.

"Persistent [Systems] has been a true partner in helping us figure out the details around our processes and what can be done and can't be done, and how to optimize the system. As we went through the system-build process together, they enabled us to have a closer look at the details of what we're doing, how and why are we do things a certain way and then look at it from a systems standpoint to determine the best way to optimize that process, and how to do it differently via an electronic system.

"Our biggest issues have been internal—identifying the users, owners, and things like that. We haven't really hit any problems and there's nothing we have asked Persistent Systems for which they've come back to us and said we can't do that or we can't accommodate," adds Mills. pP