GXP Services
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Our GXP Services include:
Testing under GAMP 5 includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), ensuring correct installation, normal operation, and performance in various conditions.
EU Annex 11, a European Union requirement, demands validation, data integrity, and controlled system changes.
21 CFR Part 11, a U.S. regulation, enforces security, reliability, and accuracy of electronic records and valid electronic signatures, applying to all computerized systems in regulated industries.
We utilize the V-model of GAMP-5 for software qualification. Altogether, GAMP 5, EU Annex 11, and 21 CFR Part 11 create a comprehensive framework for ensuring the reliability, consistency, and compliance of computerized systems. CSV is pivotal in ensuring these systems operate effectively and meet regulatory standards.
Our expert team specializes in software validation according to GAMP-5, EU Annex 11, and 21 CFR Part 11. Here is a list of software successfully validated by our team:
- LIMS
- SAP
- Track Wise (e-QMS)
- BMS
- Empower-3, Chromeleon 7.3
- Lab solution, Tiamo, Autopol, Lab X, Mass Hunter
- SCADA, PLC
- Other Production and Laboratory software”
Management systems, particularly in quality and knowledge domains, drive organizational improvement, uncovering short and long-term enhancement opportunities. Operational Excellence is an ongoing journey, demanding adaptability and agility in the ever-evolving business landscape.
Cultivating a culture of continuous improvement, via training, process reviews, and innovation, is crucial. It demands a commitment to long-term goals over short-term gains, reinventing operations, and embracing change.
Our Operational Excellence service encompasses Process Simplification, Productivity Enhancement, and OEE improvement, pivotal for sustained business success.
Following are the areas that we support organizations to attain operational excellence.
- Reduce Paperwork (Automating the process)
- Standardize processes (Mastering complexity through simplification)
- Improve the lifetime of the assets
- Integrate all technologies
- OEE improvement
- Cybersecurity
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Schedule your free consultation today and take the first step towards achieving your goals.
Our experts provide remediation services for Data integrity issues, Quality culture revamping, QMS redeployment, Risk assessment, Green field project.
- Data Integrity Issues: We specialize in resolving data integrity challenges, ensuring the accuracy, completeness, and reliability of critical data across your operations.
- Quality Culture Enhancement: Our services encompass the revitalization of your organizational culture to prioritize and embed a strong quality ethos.
- QMS Redeployment: We assist in the strategic redeployment of Quality Management Systems (QMS) to optimize processes and adherence to regulatory standards.
- Risk Assessment: Our experts conduct comprehensive risk assessments to identify and mitigate potential issues, safeguarding your operations.
- Greenfield Project Support: We provide guidance and support for greenfield projects, ensuring they are planned and executed in alignment with best practices and compliance requirements.”
GMP audit services encompass the evaluation of an organization’s adherence to Good Manufacturing Practices (GMPs). GMPs consist of essential guidelines and regulations governing the consistent and controlled production of pharmaceuticals, medical devices, and food products to uphold stringent quality standards. The primary objective of a GMP audit is to guarantee the safety and consistent quality of products, ensuring they meet customer expectations—consistency in appearance and functionality with each production cycle.
Third Party Audit
- Data Integrity
- Gap assessment
- Pre and post inspection audit
- Pre and post inspection audit
- FDA (MOCK) audit
- Vendor identification
- Vendor development:
- Vendor approval
- Periodic audit
- FDA (MOCK) audit
Training and people development are integral to a successful Good Manufacturing Practices (GMP) program. Competency assessments tailored to individual job responsibilities identify precise training needs.
The rapid evolution of technology profoundly impacts the pharmaceutical industry, reshaping medical practices, production methods, healthcare systems, and patient expectations. Hence, it’s vital that pharmaceutical staff comprehend these shifts, especially frontline employees who serve as trusted customer touchpoints.
Effective training strategies are essential.
- Training on cGMP, GDP, or GLP
- Training on Audit Behavior and FDA audit readiness
- Training on Computer System Validation (CSV) and Cybersecurity Assessment (CSA)
- Training on human error reduction
- Training on scientific investigations
- Soft skill and leadership training
- On-demand training (Tailored training modules as per customer requirement)
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