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.
Trending articles
How Enterprise Architects can get more support for technology led innovation
Enterprise Architects are increasingly vital as guides for technology-led innovation, but they often struggle with obstacles like siloed teams, misaligned priorities, outdated governance, and unclear strategic value. The blog outlines six core challenges—stakeholder engagement, tool selection, IT-business integration, security compliance, operational balance, and sustaining innovation—and offers a proactive roadmap: embrace a “fail fast, learn fast” mindset; align product roadmaps with enterprise architecture; build shared, modular platforms; and adopt agile governance supported by orchestration tooling.
Why combine an Internal Developer Portal and a Data Fabric Studio?
Are you asking this exact question? You’re not alone! Many IT leaders are on a quest to improve efficiency and spark innovation in their software development and data engineering processes. You may wonder why it’s a good idea to combine an Internal Developer Portal and a Data Fabric Studio – what’s the benefit? What IT…
Data mesh vs data fabric: Understanding key differences and benefits
One thing I love about working in tech is that the landscape is constantly changing. Like the weeping angels in Dr Who – every time you turn back and look – the tech landscape has moved slightly. Unlike the weeping angels, however – this progress is for the betterment of all. (And slightly less murderous).…
Best practices for developing AI solutions with a self-service platform
Enterprises are feeling increasing pressure to integrate Artificial Intelligence (AI) into their operations. This urgency is pushing leadership teams to adjust their investment strategies to keep up. Recent advancements in Generative AI (GenAI) are further increasing this pressure, as these technologies promise to enhance productivity and efficiency across the organization. For example, Gartner™ expects GenAI…
