Successful validation of Calibo’s GxP compatibility by top auditing firm

Summary

Calibo has achieved full validation for GxP regulatory compliance—covering GMP, GLP, and GCP—after a thorough gap analysis and verification conducted by KPMG, confirming alignment with both U.S. FDA 21 CFR Part 11 and EU Annex 11 requirements.

The platform supports critical needs in regulated industries through robust data integrity and traceability, advanced document management (including versioning, e-signatures, and audit trails), automated processes designed for compliance, and secure collaboration tools.

Action points: assess your compliance needs against 21 CFR Part 11 and Annex 11; evaluate how your current tooling supports data integrity, documentation controls, and auditability; test Calibo’s deployment against these regulatory scenarios; and plan to leverage Calibo’s validated capabilities to streamline regulatory adherence with confidence.

In a market that’s continuously adapting to more rigorous regulatory standards, companies within various sectors (such as life sciences, pharmaceuticals, biotechnology, medical devices, healthcare, food and beverage, cosmetics and agriculture) are rigorously working to uphold stringent compliance measures.  

Adherence to protocols such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) – collectively termed GxP – is indispensable.  

This is critical because these protocols directly impact consumer safety and public health. Non-compliance can lead to serious legal consequences and, more importantly, put patients at risk. 

As of November 2023, the Calibo platform has positioned itself at the forefront of software providers by integrating GxP regulatory requirements. 

“Our alignment with GxP requirements is a game-changer for companies in these sectors. By ensuring our platform meets these stringent standards, we provide our clients with a robust foundation for maintaining data integrity and traceability. This is crucial for their products’ life cycle.” Scott Sandschafer, Chief Executive Officer, Calibo. 

Calibo GxP evaluation process  

The Calibo platform underwent a thorough evaluation of its technical and procedural controls to ensure alignment with the stringent standards of GxP regulations. This review was meticulously guided by the regulatory specifications outlined in: 

• 21 CFR Part 11 Subpart B, which defines the U.S. FDA’s regulations on electronic records. 
• EU Annex 11, detailing the European Union’s regulatory requirements. 

KPMG performed an in-depth gap analysis to identify areas for enhancement and subsequently presented a report outlining recommended corrective actions. The Calibo team diligently addressed and implemented these suggestions, all of which were subject to successful validation by KPMG. 

The Calibo platform fully aligns with the GxP-related controls as delineated by the regulatory standards and guidelines previously mentioned. 

Understanding GxP compliance 

GxP represents a series of quality guidelines and regulations designed to guarantee the integrity, traceability, and dependability of data in the life sciences arena. Far from being optional, GxP compliance is foundational for the ethical development, production, and distribution of pharmaceuticals, biologics, and medical devices. 

Calibo – tailored for GxP compliance

Calibo stands distinguished as a transformative presence, offering a robust solution for organizations working towards seamless GxP regulatory compliance. Calibo mirrors the GxP ethos through: 

1. Data integrity and traceability 

With data at the heart of integrity, Calibo provides a secure, transparent haven for managing critical data. The platform ensures consistent accuracy and availability, reinforcing the traceability across all stages of the product lifecycle. 

2. Document management 

Recognizing the pivotal role of documentation in a GxP-compliant setting, Calibo touts sophisticated controls over document management. Blending creation, review, and storage procedures with best practices like versioning, e-signatures, and audit trails, it’s a system built for unmatched document veracity. 

3. Process automation 

Calibo elevates consistency and mitigates human error through strategic process automation, reinforcing reliable workflow execution. Its automation utilities are consciously crafted, keeping GxP regulations at their core. 

4. Collaboration and communication 

The life sciences sector thrives on collaboration, and Calibo champions collaborative efforts without sacrificing compliance. Through secure communication channels and tools, it catalyzes teamwork effectiveness within the boundaries of regulatory compliance. 

For enterprises that need to adhere to strict regulation, selecting technology tailored to GxP compliance is essential. Calibo emerges as a groundbreaking platform, adeptly qualifying for the rigors of GxP regulations. As organizations chart their course through the intricacies of product development and market introduction, Calibo offers unwavering support.  

Learn more here. 

FAQ

What does Calibo’s GxP validation mean for organizations?
It confirms that Calibo meets strict regulatory requirements under FDA 21 CFR Part 11 and EU Annex 11, ensuring data integrity, traceability, and compliance for regulated industries.

How was the validation achieved?
An independent audit conducted by KPMG performed a gap analysis and thorough verification, confirming Calibo’s compliance with Good Manufacturing, Laboratory, and Clinical Practices (GMP, GLP, GCP).

What key capabilities support GxP compliance in Calibo?
Features include advanced document management with version control and e-signatures, audit trails, automated compliance-driven workflows, and secure collaboration tools.