sector

Pharma & Biotech

Adhere to regulations concerning data safety, integrity, and traceability. Save time in managing your business processes. Make more informed decisions by finally harnessing your data easily.

Compliance: Demanding and Ever-Evolving Regulations

Regulatory compliance is a major concern for the pharmaceutical and biotechnology industries. Stringent standards are imposed on the Life Sciences sector to ensure patient safety, product quality, and data reliability. Compliance for these companies becomes even more challenging as regulations constantly evolve, especially with the implementation of international certification standards.

Companies must provide documented evidence for the maintenance and market release of healthcare products. Using spreadsheet software like Excel™ and paper-based methods does not align with regulatory requirements for data safety, integrity, and traceability. Therefore, companies are compelled to digitize their procedures to meet compliance standards and avoid legal and financial consequences

Businesses’ needs

Digitize Business Processes: To eliminate manual procedures (such as Excel™ and paper), the GxpManager No Code Low Code platform is ideal for quickly digitizing forms and more complex processes.
Compliant Business Applications: Businesses require compliant applications to facilitate the creation of documented evidence. GxpManager applications inherently comply with 21 CFR Part 11 and Annex 11 of Good Manufacturing Practices (GMP), offering features like electronic signatures, audit trails, and access management.
Simplified Application Validation/Qualification Processes: The GxpManager platform comes pre-qualified (Installation Qualification – IQ and Operational Qualification – OQ), reducing the validation cost.
Agile Solutions for Regulatory Adaptability: In this ever-evolving sector, businesses need agile solutions to adapt to regulatory changes. Our applications are developed using No Code Low Code, providing significant flexibility.

eQMS: An Effective Quality Management System, a Real Competitive Advantage

A quality deficiency can result in significant time and revenue loss.

Incorrect, incomplete, outdated, or duplicate data, no matter how small, can lead to decreased productivity, missed deadlines, or missed opportunities.

With GxpManager, establish a culture of excellence in quality within your organization. Centralize your quality processes around a single platform:

Traceability (audit trail): Track all modifications to ensure the integrity and consistency of data subject to regulations.
Streamline internal and external audits.
Quality documentation management.
Manage quality actions related to non-conformities, complaints, and changes.
Monitor training activities.

The benefits

Save time:

In managing your quality actions through tailored workflows and real-time task tracking.
In reducing non-conformities and other common human errors associated with manual procedures.

Simplify your audits with compliant applications:

Every action is traced through an audit trail.
Data integrity is guaranteed. Each action is assigned to an operator through electronic signatures.
All data is stored in our highly secure data centers in France

Data Management and Business Intelligence: a Source of Benefits

The mastery and management of data have become essential to ensure the sustainability of pharmaceutical and biotechnological companies. The digital transformation of businesses enables them to make more informed decisions, accelerate drug development, reduce compliance costs, and enhance product quality.

With GxpManager, go beyond mere data collection; capitalize on your data and harness its potential:

Digitizing documents allows immediate and straightforward access to actionable data rather than burying it in hundreds of documents.
Digitizing business processes to optimize R&D, validation, production, and market entry processes.
Monitoring and analyzing key indicators help extract strategic insights, identifying opportunities and areas for improvement. With GxpAnalytics, all departmental data is readily exploitable through the most powerful BI tool.

Why digitize your business with GxpManager

GxpManager: Your Partner in the Pharma and Biotech Industries

Since 2003, GxpManager has leveraged its expertise in industry-specific applications for the healthcare sector, resulting in a deep understanding of our clients’ regulatory and business challenges.