Nulogy announces new capabilities to enable validation and compliance in regulated supply chains
05 Dec, 2019, 12:00 ET
TORONTO, Dec. 5, 2019 /CNW/ - Nulogy, a leading provider of agile supply chain solutions, today announced enhanced capabilities to help consumer brands and contract suppliers in regulated environments meet compliance requirements, improve product quality, and uphold consumer safety.
Nulogy's capabilities are designed to support suppliers within the healthcare, life sciences, and pharmaceutical industries with meeting the requirements of Good Manufacturing Practices (GMP) and with effectively validating their systems.
Nulogy customer, Unette Corporation, a New Jersey-based contract filling specialist for the pharmaceutical, life sciences, and cosmetic industries, has closely partnered with Nulogy in its development of validation capabilities such as part 21 CFR Part 11 audit trails, and leverages Nulogy's solution to maintain their high levels of compliance.
"cGMP compliance is the cornerstone of Unette's business in the personal care and pharmaceutical industries. Nulogy has been a strong partner and a valuable resource for ourselves and our customers at Unette," said Jennifer Squillante, Director of Quality at Unette. "By electronically tracking component usage and finished good production, the Nulogy platform allows us to perform traceability exercises in real-time. Within minutes we can tell our customers where their components were used and where the finished goods were shipped to."
"Increasing product quality expectations and tightening regulatory requirements can make it complex, costly, and risky to serve regulated environments," says Jason Tham, CEO, Nulogy. "With Nulogy's new capabilities and service offerings, we help consumer brands and suppliers that operate in regulated environments adapt their businesses to this new level of complexity and ensure reliable, consistent service delivery."
Key Nulogy capabilities that enable regulatory compliance include:
- Quality control capabilities such as electronic signatures, audit trails, electronic batch records and digital quality checks that enable suppliers in regulated environments to demonstrate compliance;
- Release management capabilities that provide users with greater ability to manage software service updates and any related change control or re-validation activities;
- Extended data retention capabilities to assist customers in meeting their document retention requirements; and
- Nulogy's Computer System Validation Guide, designed to reduce the burden of validation efforts. Nulogy's Computer System Validation Guide provides valuable documentation related to Nulogy's verification and development activities, as well as compliance to 21 CFR Part 11 and Annex 11.
To further support customers' validation efforts, Nulogy offers additional hands-on services to ensure customer confidence in carrying out validation activities, while helping reduce the risk of software-related audit observations and avoiding potential quality issues that could impact a business's reputation and bottom line.
To learn more about how Nulogy helps brands and suppliers bring customized products to market with agility, visit www.nulogy.com.
Nulogy's cloud-based Agile Customization Platform allows consumer brands to respond with ease and speed to a volatile retail and consumer environment while reducing waste and costs. Designed to optimize contract packaging and manufacturing operations and enhance supply chain collaboration, Nulogy's software solution allows consumer brands and their external suppliers to unleash innovation in the consumer products value chain and accelerate brand growth.
About Unette Corporation
Unette Corporation, the originator of single-use tubes, was established in 1955 and is headquartered in Randolph, New Jersey. Unette is an FDA registered, cGMP compliant contract packaging organization specializing in primary liquid filling for the pharmaceutical, life sciences and cosmetic industries. To learn more, visit www.unette.com.
SOURCE Nulogy Corporation
For further information: Media Contact, Daisy Jiang, Director, Marketing, Nulogy Corporation, [email protected]
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