Save Time, Reduce Cost of Implementing a Validated Labeling Solution
Now you can streamline the validation workload for a standardized Enterprise Labeling Solution while meeting evolving FDA and EU regulatory requirements.
USDM Life Sciences—a leading global regulatory consulting firm in the life sciences industry—and Loftware have partnered to develop a Validation Accelerator Pack (VAP) to simplify compliance, increase productivity and minimize costs. The Loftware Spectrum VAP enables pharmaceutical and medical device companies to quickly and cost-effectively implement and maintain a validated, compliant labeling solution.
The Loftware Spectrum VAP leverages the industry's most powerful barcode labeling solution to address the unique complexities of labeling in the life sciences space. When paired with Spectrum's configurable workflow framework and eSignature capabilities, the Loftware Spectrum VAP provides a jump-start towards validation and helps to facilitate 21 CFR Part 11 labeling, underscoring Loftware's ongoing commitment to pharmaceutical and medical device labeling.
As USDM's only VAP for an Enterprise Labeling Solution, the Loftware Spectrum VAP provides a set of content-rich validation templates that are ready to be configured to reflect your implementation decisions:
- Validation Plan
- System Requirement Specifications
- Functional Risk Assessment
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Traceability Matrix
- Validation Summary Report
- 21 CFR Part 11 Assessment
The VAP templates are in MS Word and can be easily updated to include your specific information and project details.
Download the Loftware Spectrum VAP data sheet for the Medical Device Industry and Pharmaceutical Industry.
To learn more about getting started with your Loftware Spectrum VAP, contact us at SalesInfo@loftware.com
"The Loftware VAP helps life science companies meet regulatory challenges, while reducing validation time and costs up to 50%."
- Jay Crowley, Vice President
UDI Services and Solutions, USDM Life Sciences