Brochures

Prisym Medica Whitepaper

Prisym Medica Brochure

FDA Compliant Labeling Software

PRISYM Medica is the worlds only integrated pharmaceutical label design and production software specifically developed to meet the FDA's current 21 CFR Part 11 and GMP requirements. It can be applied to research, development, manufacturing and distribution activities that require auditable security protocols and life cycle documentation based on the GAMP V Model.

PRISYM Medica can help in meeting GLP, GCP, GMP and ISO requirements for sample/material/product labeling and record keeping.

Deliverables

• Fully-compliant label printing and management
• Secure event logging
• Automatic version history logging
• Signature to record linking (electronic)
• Proven date and time stamping
• Password protected records (encrypted)
• Time elapsing, two component passwords
• Automatic anti-tamper detection
• Full product life cycle documentation

Options

• Biometric passwords
• IQ, OQ and PQ testing
• Custom validation of installed system
• Custom software development and integration
• Custom database design and integration
• Custom maintenance and servicing
• Custom support and training

Applications

• Compliant label production & management
• Research material storage & transfer
• Compliant product trials
• Compliant product packaging
• Compliant product distribution