Artwork Management for Life Sciences
Packaging artwork management without the right tools can be chaotic and error-prone. Organizations today are under immense pressure to reduce their time-to-market. Urgency coupled with stringent regulations and lack of coordination between various stakeholders can cause errors and product recalls. ManageArtworks can help you manage your packaging artworks from design to launch.
SYSTEM CAPABILITIES THAT HELP ENSURE 21 CFR COMPLIANCE
- Artwork Approval Workflow
Ensure all stakeholders approve the artwork before it’s sent to print. You can control who has to do what and when. You can customize workflows, set durations, create alerts and reminders, and have the flexibility to designate, pullback, and forward files with the rest.
- Asset Library
Access a single source of truth with version control, access rights, quick search supporting multiple file formats. Search for artworks in a central library, tag artworks with any keyword, browse files or filter using metadata with thumbnails for quick preview. With the system automatically managing all revisions, users are guaranteed to see the latest version without guessing.
- Image Compare
Proofread graphics and verify all changes requested by teams have been made. You can now align, compare, and report the differences in multilingual text, barcodes, and images.
- Text Compare
Prevent hundreds of hours staring at the brief and the final artwork/pack insert and verifying them one line at a time. It’s a relentlessly tedious process to begin with and it is not immune to errors even with a team of 5 verifying it. And then imagine repeating the process every time the FDA directs you to make some changes in the insert. With text-compare, you can also compare text in any language and between files of different formats.
- Compare Briefs
Identify deviations between a brief document and an artwork. Upload a brief document in any format (Word, Excel or PDF) and compare it with your artwork PDF.
- Print Inspection Tool
Compare digital artwork against the scanned artwork for labels, cartons, and leaflets. You can choose the regions you wish to compare on your artwork and identify trapping, bad registration, and cutting issues.
- Braille Verification Tool
A misplaced Braille dot or wrong spacing among the dots could mean something entirely for a person reading the Braille. It could mean an incorrect product name or dosage information which may have disastrous consequences for the visually challenged person. With ManageArtworks, you can now verify your Braille component on the artworks with ease.
- Analyze Font, Color, Barcodes, and Layers
Extract font information from your packaging artworks. Simply hover over the text for which you wish to find the font information. Learn about font name, height, cap height, X-height, width, and more. Verify CMYK and Pantones used on your artwork files with ease. Automatically recognize 1D and 2D Barcodes and verify their quality against each variable. Check if the layers on your artwork have been arranged appropriately to check for overprint and transparency.
- Reporting and Metrics
Get insights from real-time data. Identify bottlenecks in the workflow, monitor status of the projects, causes for rework and ensure that your artworks are released on time. Important metrics include: status of all approvals split into stages, which activity is causing the most delays, how many reworks are being done on an average and what are the top 5 reasons for rejection. With all the data captured and analyzed, custom reports can be built to get you the right data in the right format.
- Take control of your Artwork Lifecycle
From Drug Registration to Print Destruction, artworks are present at every stage of the process. ManageArtworks has been implemented in validated environments to automate the processes involved in the artwork lifecycle. Whether the process involves your own manufacturing unit, contract manufacturers, third-party manufacturers or Loan License manufacturers, we have done it all.
- Sleep easy with automation in place
Changing regulatory requirements and the numerous hand-offs require extensive reviews and proof-reading to ensure that the printed label is error-free. As your business expands and newer internal and external stakeholders are brought on board, not having a collaborative online system adds significantly to cost and time. ManageArtworks can help you transition from a manual to a digital system and reap the benefits of automation.
- 21 CFR Part 11 Compliance
ManageArtworks has built-in features to help your organization enhance your Part 11 compliance:
Access Control with Password Policies
User and Role based Security Settings
Audit Trails with Timestamps
Electronic Signatures with Authentication and Logging
SSL based communication and more
Computer System Validation is a key cGMP requirement that checks the effectiveness and efficiency with which the system is meeting the purpose for which it was designed. We can help your company in the CSV process by sharing templates for Validation Master Plan, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
We’d be glad to help you become more proactive pre-launch instead of being reactive post-launch.
Have our experts reach out to you and demonstrate how.