Aurobindo Utilizes the SciCord Platform for Successful Generic Filing

Fast-Tracking Regulatory Approval: Aurobindo’s Journey with SciCord’s Lab Digitization

Aurobindo Utilizes the SciCord Platform for Successful Generic Filing

Situation:

Aurobindo, a multinational pharmaceutical manufacturing company headquartered in India, operates across 15 locations spanning 5 countries, with a focus on pharmaceutical manufacturing and R&D. With a workforce of over 1,560 scientists, Aurobindo boasts in-house expertise in product development areas including API, peptides, custom synthesis, and formulations for oral, injectable/parenteral, and ophthalmic delivery systems.

In 2016, Aurobindo embarked on a significant endeavor, establishing a new department dedicated to developing generic inhaled formulations. This move positioned Aurobindo to compete in the competitive generic inhaled formulations market, challenging established brands. However, the venture came with its unique set of challenges. Regulatory hurdles loomed large, requiring Aurobindo to demonstrate bioequivalence, in vitro-in vivo correlation, and navigate complex intellectual property laws and stringent quality standards. Moreover, ensuring therapeutic interchangeability and addressing patient usability added further complexity to the competitive landscape, necessitating speed and cost-effectiveness.

Overcoming these obstacles demanded strategic investment in scientific research, regulatory expertise, and market differentiation strategies, all while maintaining stringent regulatory compliance and quality assurance standards.

Challenges:

Prior to SciCord implementation, Aurobindo relied entirely on manual processes, leading to:

Increased risk of errors and compromised data integrity.
Inefficient paper-based document management, hindering control over document lifecycles.
Anticipated influx of new scientists requiring extensive training, posing potential sources of error and non-compliance.
Limited scalability of manual systems for growing operations.
Crucial need for quality data generation “right the first time,” vital for analyzing clinical material, ensuring stability, and supporting regulatory filings.

Impact:

The successful development and regulatory approval of an inhaled product held significant implications for Aurobindo’s bottom line and the future of the new development group. Implementation of SciCord in 2016 provided several notable impacts:

Digitized data facilitated easy identification as well as a significantly reduced error rate and preparation time for audits.
Controlled review and approval of notebooks ensured adherence to defined processes.
Aurobindo’s subsidiary gained US FDA approval for their generic inhalation suspension (bioequivalent to Pulmicort) since implementing SciCord in 2016.
Implementation of lab execution processes recorded all required information and markedly reduced training time/resources required for new staff.

“

We have been audited by FDA twice and they had no concerns about the system nor any findings.”

– Deb Carr, Director, IPD

The cost of an FDA audit issue can range from tens of thousands to millions of dollars. By implementing SciCord’s solution and improving compliance measures, Aurobindo can avoid or mitigate these costs, resulting in significant cost savings.

A Platform Built for Compliance

The SciCord Informatics Platform is purpose-built to establish a compliant laboratory environment, ensuring the generation of high-quality data.

The Challenges of Compliance
in an Informatics System

Pharmaceutical laboratories that produce data and information for regulatory agencies face the difficult task of implementing systems and processes that comply with regulations. The effort required to establish and maintain compliance can negatively affect lab efficiency and incur additional cost.

The Impact of
Poor Compliance

Without proper control and management, data can be improperly attributed, have insufficient auditing to prove it is correct, or be lost altogether. However, an overly restrictive electronic lab system can impede effective data visualization/analysis in order to achieve compliance.

The SciCord Solution

SciCord’s core is built from the ground up with compliance in mind – full audit trails, secure and automated attribution, CFR Part 11 compliant data storage, and validated calculations. On top of this core, a flexible no-code configuration system allows your processes to be fully captured.

Benefits:

Using SciCord Informatics Platform, Aurobindo lab information was digitized to facilitate compliance:

Data integrity measures for data entry, review, audit trails, data backup, data security, and electronic records management.
Controlled document (notebook/experiment) lifecycles guarantee that laboratory records are authored, reviewed, and approved as required.
Minimum 30% increase in reviewer efficiency results in timely document reviews.
Process execution modules ensure strict adherence to step-by-step processes and comprehensive recording of all required information.
Efficient management of instruments, equipment, and chemical inventory.
Streamlined training management (curriculums and records) for teams with variable skill levels.
User-friendly interface with scalability for large and small teams.
Analytical Execution Systems (DDU, NGI, Moisture, Leak Rate)
Quality Documentation (Change Control, Test Methods, protocols, investigations, deviations)
Validation Materials (Requirements, Risk Assessments, IQ, OQ, PQ, Validation Plans and Reports)

SciCord Informatics Platform is a critical ingredient in driving quality and compliance in your organization.

Case
Studies

Case Studies

Pearl improved the review process by 30%

Read Case Study

Pearl Therapeutics harnessed the SciCord platform to improve their data management and review processes implementing a fully paperless solution, resulting in a 30% improvement in efficiency and supporting successful FDA filings.

Aurobindo used the SciCord Platform for successful generic filing

Read Case Study

Discover how Aurobindo achieved improved compliance, expedited product to market, and successful FDA audits, improving its generic drug development process using the SciCord platform.

Formulated Solutions Achieves Operational Excellence with SciCord

Read Case Study

Discover how SciCord transformed lab operations by providing streamlined data management, regulatory compliance, and unified performance across multiple sites. And how this transformation led to substantial efficiency improvements and cost savings.

Trusted by Organizations of All Sizes

Contact
Us

Reach out to Schedule a Meeting and get more information about how SciCord can fit into your lab

What Our
Users Say

Don’t take our word for it.
We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.

“

This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.

”

Josh Guyer,
Senior Pharmaceutical Scientist

Platform and Features

Main Features

More

Solutions

See our Customer’s Success

Resources

Case Studies

Key Items

Aurobindo Utilizes the SciCord Platform for Successful Generic Filing

Fast-Tracking Regulatory Approval: Aurobindo’s Journey with SciCord’s Lab Digitization