throughout your biopharma manufacturing supply chain.
Elevate Data Visibility and Integrity
More complex processes and data, global teams, sites and partners, spreadsheets and disparate systems, accelerated timelines, regulatory scrutiny – all contribute to the challenge biopharma sponsors and contract manufacturers (CMOs) face to ensure critical process data can be trusted and used to efficiently produce the highest quality products.
Take a proactive, collaborative approach to these challenges with innovative cloud-based technology.
With Skyland PIMS cloud-based process information management system, your team will improve data integrity, remain compliant, and make better, faster product and process decisions with confidence.
Have Confidence in Your Data – Here’s How
Still relying on spreadsheets, paper records and disparate data systems? Data integrity has risen to the top of the list of risks biopharma companies are addressing. Download this paper and discover key insights to achieving manufacturing data integrity with process information management systems.
Centralized, Persistent, Dynamic Knowledge Base
Capture and contextualize all types of data – digital, paper, manually-entered, queried and calculated – from development through commercial manufacturing.
Secure Data Sharing Across Teams, Sites and Partners
Drive collaboration and timely data access while aligning data entry, transfer, viewing, and approvals with business needs, SOPs, and FDA guidelines.
FDA Compliant and Easily Validated
Meets the strict requirements of 21 CFR Part 11 and provides a complete audit trail of data entries, including authorship, change justifications, and time stamps.
Scalable, Flexible and Intuitive
Fits all IT landscapes. The first digital tool to move away from paper and Excel – and a springboard or complement to other systems. Quick to deploy and easily configurable.
PIMS Raw MaterialsTM
Skyland PIMS Benefits
Enhance Process Monitoring and Understanding
Streamline Business and Regulatory Reporting, e.g., CPV, APQR, CMC, Investigations, Audits
“We needed to move fast on our COVID-19 vaccine, replace Excel data management, and accelerate CMO data sharing, PIMS was the perfect product.”
Director of Data and Analytics for Novavax
Improve Operational Efficiency and Lower Cost of Compliance
Expedite Scale-up, Tech Transfer and Batch Release
“PIMS is especially helpful because everyone’s working off the same set of data and able to have access to it in real time. The ability to investigate and make sure the process is operating properly is greatly improved”
Head of Biologics for Patheon