GAMP 5
Introduction
GAMP 5 (Good Automated Manufacturing Practice) is a globally recognized framework for ensuring quality and compliance in automated systems used in the life sciences industry. At Mindbridge Consulting, we help organizations navigate the complexities of GAMP 5 to ensure regulatory compliance, improve operational efficiency, and maintain product quality.
Why GAMP5 Matters
Regulatory Adherence
Meet stringent requirements from agencies like the FDA, EMA, and MHRA.
Quality Assurance
Maintain the integrity and safety of products through robust automated processes.
Risk Mitigation
Identify and address potential risks in computerized systems to prevent compliance issues.
Operational Efficiency
Streamline processes and reduce errors in automated manufacturing environments.
Our GAMP 5 Services
Gap Analysis and Readiness Assessments
Evaluate current systems against GAMP 5 requirements.
Identify gaps and provide actionable recommendations to achieve compliance.
Framework Development
Design and implement quality management frameworks that align with GAMP 5 principles.
Develop documentation, including Standard Operating Procedures (SOPs) and Validation Master Plans (VMPs).
System Validation and Testing
Conduct risk-based validation of computerized systems.
Perform testing to ensure systems operate as intended and meet regulatory standards.
Training and Support
Provide comprehensive training for your team on GAMP 5 principles and practices.
Offer ongoing support to maintain compliance as systems evolve.
Industries we Serve
Our GAMP 5 solutions are ideal for:
Why Partner with Mindbridge Consulting?
Expertise in Life Sciences
Our team has extensive experience in regulated industries and GAMP 5 compliance.
Tailored Solutions
We customize our services to meet your specific operational and regulatory needs.
Proven Results
We’ve helped numerous organizations achieve compliance and optimize their automated systems.
Why GAMP 5?
Ensure your automated systems are compliant, efficient, and ready to support your business goals. Contact us today to learn how our GAMP 5 solutions can benefit your organization.
- Build Trust and Credibility
- Mitigate Risks
- Gain a Competitive Advantage
- Drive Innovation and Efficiency
- Ensure Long-Term Sustainability
- Simplify Integration with Other Standards
- Foster Stakeholder Engagement
Implementation
Passionate – Dedicated – Professional
Reach out for a free assessment
Take the first step toward building a stronger, more resilient organization.
Contact us today to schedule your audit and start your journey to excellence.
What our clients say about us
The audit process conducted by BSI really made it clear how far we had to go to achieve certification. Luckily when Paavan and the team got involved, they made implementation an absolute pleasure and had the job done in a matter of weeks for us. Would certainly recommend.
As someone who never really took cybersecurity or compliance that seriously, it unfortunately took becoming a victim of malware for me to appreciate how important resilience is. Mindbridge Consulting made sure that it would never happen again and restored our reputation, always keeping our budget considerations in mind.
We had been an Elastic customer for years, but once we showed our setup to Dexter and the team they showed us how little we were utilising the tools. After a couple of weeks, we’ve been able to reduce our MTTR and even bring out a new observability product to market at no extra cost. Soon, we’ll certainly be looking into getting ISO certified and Mindbridge will be top of the list for that service.
I was really struggling to sort out all our data for an audit, and we actually ended up failing. We decided to outsource our data governance to Mindbridge Consulting and we couldn’t be happier. We have now passed the audit and are back on track to achieving our goal of ISO certification.
