GMP Consulting and Regulatory Compliance Services
Factorytalk's Compliance team are experts in helping the regulated industries establish efficient, cost effective quality systems that will pass inspection and produce high quality products. We review current systems and support you through every step to become more efficient , robust and compliant to stand up to all regulatory challenges.
Together we will guide you through the journey to international standards.
GMP Audit Services
Our Audit services cover GMP Health Check, GMP audit readiness, Mock Audit and Post audit support to all FDA and PIC/S standards.
Qualification and Validation Services
We provide best practice templates for specification, design, risk assessment, through to test documentation. We can train our customers and provide direct assistance for their validation program as required.
GMP Consulting Services
We provide GMP consulting for all types of manufacturing operations and across the full range of processes including supply chain, warehouse, production, QC, QA, engineering and IT.
Data Integrity Consulting Services
We provide complete service to help or clients improve their data integrity including audits, improvement programs, training, and direct assistance covering all aspects of the operation, supply chain, warehouse, production, QC, QA, engineering and IT.
Healthcare and GMP Facility Design
We provide front end support to customers new facility projects covering concept design and basic design, URS, risk assessments, equipment selection. We provide qualification and validation services as described above.
Quality System Management Remediation
We review, design and implement / improve any Quality System, including for QA, Manufacturing, Laboratories, and support groups.
We help companies develop their IT strategy and develop the long term IT vision and plan to support their business. We identify possible solutions based on requirements. We recommend the best places to store the required GMP records to minimise validation and maximise benefit.
GMP Project Management
We provide experienced project managers for all activities described on this page. We cover all aspects from first planning to the successful conclusion of the assignment.
Overseas market development and sourcing
We offer targeted searches for suitable cooperative ventures, sales partners and acquisition candidates (M&A).
Supplier Sourcing and Assessments
We can assess your suppliers including raw material suppliers, IT suppliers, equipment suppliers and outsourced activity such as laboratory services.
To make sure we give you the most relevant information about our products and services.
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