Why Assurea?
You’re always in control.
Assurea recognizes the fast moving landscape of the life science industry and that there is not a “one-fit-for-all” solution. We believe our plans offers the best fit for reducing time and remaining cost effective.
Assurea has presence in the US, Europe, UK and India (so far!) and supports clients within biotech, SaMD and foodtech industries.
Assurea has presence in the US, Europe, UK and India (so far!) and supports clients within biotech, SaMD and foodtech industries.
#BeAssured
Our Expertise
- Provide quality oversight
- Serve as a quality unit (including batch release)
- Establish and implement QMS
- Supplier management program and audits
- Quality agreements with contract manufacturers (CMOs/CDMOs)
- Provide training development for GxP, lab operation and data integrity
- Inspection readiness program and audits
- IT infrastructure qualification program
- IaaS/ SaaS/ PaaS validation
- Cloud compliance
- Security management
- Develop IT procedures and polices:
- IT quality policy
- Business continuity plan
- Disaster recovery plans
- Back up & restore procedures
- IT access & authorization management
- Patch management
- Network operations & maintenance
- Configuration management
- IT periodic review
- Archival and storage
- IT change control management
- Workstation configuration
- Provide third party software management
- Author and review service level agreements (SLAs)
- Implement computer system validation program
- GxP impact assessment
- CSV lifecycle document development (URS, validation plan and summary report, design specification,
configuration specification, and risk assessments) - Operation of GxP applications
- Validation of excel spreadsheets
- Computer system validation for enterprise and laboratory systems
- Provide computer system validation (CSV) to computer software assurance (CSA) transition
- Develop and implement data integrity program
- Create data maps for standalone and multisystem interfaces
- Perform gap analysis and data integrity remediation
- Blockchain and decentralized ledger implementation
- Validate integrated lab platforms
- Regulatory compliance
- Vulnerability assessments
- Vendor management and supplier assessments
- Vendor risk assessments
- Validation program
- Quality considerations for plasmid and vector manufacturers
- Process performance qualification
- Ancillary studies and reagent qualification
- Aseptic process simulation
- Shipping qualification
- Process development and MSAT services
Always an A Team
Our team can create, build, and scale frameworks that are phase appropriate for fast growing clients. Clients can choose from customized suite of frameworks offered in our core plan or provide us a scope of work for our builder plan. We have contributed to several industry guidances and understand complex regulations within novel areas. Our approach is collaborative, accelerated, and practical. With Assurea, assurance doesn't have to be costly!
Core
$9999 / Month
Quality Management System
- Foundational QMS for biotech, SaMD, medtech & foodtech
- Supplier management program
Audits
- Part 11/Annex 11 compliance
- Supplier audits
- Inspection readiness audits
Trainings
- Lab operations and safety
- Good documentation practices
- Data integrity
- GxP trainings
Builder
Scope of Work
Quality and Compliance
- Establish and implement QMS
- Serve as a quality unit
- Execute & maintain supplier management program
IT and CSV
- IT infrastructure qualification
- IaaS/ SaaS/ PaaS validation
- Implement CSV program lifecycle
- Risk based approach (CSA/ GAMP5)
- CSV to CSA
Emerging Tech
- Implement blockchain & decentralized ledger
- Validate integrated lab platforms
For more information on our services, please contact us.