FDA Compliant Labeling Software

PRISYM Medica labeling software is the worlds'' only pharmaceutical and medical device coding and labeling solution specifically developed to meet the FDA''s current 21 CFR Part 11 compliance requirements. PRISYM Medica is supplied as a validated labeling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model and the pharmaceutical validation labeling regulations and FDA regulations.

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

EU Drug Labeling and GS1 Compliance

PRISYM Medica has also been developed with GMP applications in mind and also has a GS1 barcodes checker to aid compliance with the GS1 barcode standard. This means PRISYM Medica is ideal labeling software for international companies to standardize on and to show their compliance with drug labeling regulations.

Drug Labeling

PRISYM Medica is used by many of the world's top drug manufacturers and drug packaging companies to manage FDA compliant labeling activity. PRISYM Medica is used to manage drug label format and design, approval, version control and variable data such as expiry dates, lot and batch numbers and even multiple language descriptions and warnings based on approved drug regulations.

Medical Device Labeling

PRISYM Medica is ideal for medical device serialization providing a totally secure environment for coding and label design, approval, automatic gathering of variable data and printing. The solution is also compliant with barcode standards adapted for FDA medical devices labeling regulations

PRISYM Medica Features

• 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
• GS1 compliant bar coding generating GS1 Barcodes
• Drug labeling FDA validation
• FDA medical devices labeling regulations
• 2D bar coding
• Multiple language text

PRISYM Medica 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 for PRISYM Medica

• Drug FDA compliance labeling and serialization
• FDA Medical devices labeling and serialization
• FDA pharmaceutical validation
• Secure variable data labeling
• Labeling repackaged drugs or devices
• FDA compliant labeling
• Clinical trials supplies labeling
• Patient kits labeling