How do you guarantee that your products meet quality demands and comply with regulations? Through validation of your processes, equipment and software. Risk-based validation is the adequate method to prove your product is correctly prepared, packaged, labelled and transported. That’s why each quality control process in the life sciences, healthcare and cosmetics industries needs to contain a certain validation aspect.
Do you need to analyze your quality system data to gain strategic insight or respond to auditor or management requests?
VALCAL Lifesciences Pvt. Ltd. can help ensure your systems and processes comply with FDA GxP regulations by following accepted industry standards such as Good Automated Manufacturing Practices (GAMP). Any good quality system starts with a framework such as a quality manual. We assess your needs and help you determine what needs to be included in your quality system by drawing from GxP (GMP/GLP/GCP etc.) compliance and industry best practices and our valuable experience gained over the years.).
Our services are based on international regulations (including GMP, GDP and GLP guidelines, Eudralex, 21CFR part 11 and ISO 9001 etc.) and methodologies (including GAMP, LSV, CSV etc.) Our validation services include:
- Helping you create validation master plans
- Organizing validation documentation
- validation project management
- gap analysis
- risk analysis
- validation planning
- validation execution
- software validation
- preparation of validation summary report
- quality system development/sop development
- regulatory compliance assessments/support
- training program on all the regulatory and pharmaceutical topics
- Installation Qualification (IQ) protocol development & execution.
- Operational Qualification (OQ) protocol development & execution.
- Performance Qualification (PQ) protocol development & execution.
- Sterility validation for medical devices, injectable, drug delivery devices
- Validation of software that is integrated with devices, instrumentation or diagnostics
- Computer Systems Validation
- Risk management
- Compliance monitoring
- Corrective and preventive action (CAPA)
- Complaint management
- Vendor management
- Corporate quality manual
- SOP Templates
- Organizational design