Scanning vital production files ensures compliance for Mentor Medical
Digitisation of batch records
to improve data access
Document scanning and offsite
- Access to vital files in
seconds rather than days
- Improved operational efficiency
- Simplified and accelerated
Maintaining exemplary quality standards
Part of Johnson & Johnson, Mentor Medical is a world leader
in breast implant manufacturing, research and testing. It has
an enviable reputation, consistently recognised by medical
professionals for outstanding product integrity.
Mentor Medical has its European manufacturing centre at the
Leiden Bio Science Park in the Netherlands. Products made
there are of the highest quality, with strict standards of design
and testing. Every step of the manufacturing process is tightly
controlled and documented, with records retained for up
to 125 years.
“We keep meticulous records to assure full traceability and batch
identity,” says Sjaco Baas, Site Records Manager at Mentor Medical.
For example, source data of raw materials, silicon chemical analysis
results, time-stamped oven temperature graphs and equipment
maintenance schedules. Records are validated and signed by
qualified persons, for sound evidence should an investigation
ever be required.
“Our batch records have traditionally been kept in paper form,
stored off-site by Iron Mountain®,” continues Sjaco. “Although this
arrangement has served us well we need to continually enhance
our procedures for greater efficiency.”
Speeding evidence for external audits
The Mentor Medical manufacturing process is subject to audit
checks from customers and global regulatory bodies. Auditors
often ask to see evidence of manufacturing controls, requiring
documents to be retrieved from the off-site archive. “Digitising
our batch records would speed up access,” says Sjaco Baas. “That
would help us get audit activity concluded much faster.”
In considering file scanning it was natural for Mentor Medical to
turn to Iron Mountain as custodian of its batch files.
“Having our batch records available
in digital form means we have access
to working copies of vital records in
seconds rather than days.”
Site Records Manager
With the assistance of Iron Mountain’s Project Governance Specialist, Mentor Medical
created a statement of work to define project activities, timelines and deliverables.
That led to an initial pilot to scan 20 boxes of production files. Sjaco Baas
confirms; “We learned a lot during that pilot and from it we were able to develop a
comprehensive 35-page work instruction.”
A second pilot exercise followed. The successful scanning of 50,000 pages of files
validated that work instruction. As part of the agreement to proceed, Mentor Medical
conducted an audit of the Iron Mountain scanning centre.
“The site visit helped us visualise the process as well as confirm Iron Mountain safety
and security provisions at first hand,” says Sjaco Baas.
Moving to full-scale digitisation
With the process proven and file structure defined, Iron Mountain embarked on
full-scale digitisation of the Mentor Medical records archive. Over the next months
Iron Mountain created more than 1.6 million PDF images, made available via a secure
portal for download into the Mentor Medical document management system.
Now the back-catalogue has been fully digitised, new batch records are routinely
collated and sent for scanning. Each month Iron Mountain collects and scans around
20 boxes of files, creating around 50,000 PDF images for download within a 10-day
timeframe. Once scanned the original paper files are archived, to remain available if
ever required; for example, in the unlikely event of a legal enquiry.
“Having our batch records available in digital form means we have access to working
copies of vital records in seconds rather than days,” says Sjaco Baas. “It’s just a far
more effective and efficient way to work.”
Developing a strong business relationship
The association between Mentor Medical and Iron Mountain continues to evolve. For
example, Iron Mountain recently supported the company following the closure of
a manufacturing facility in Mauritius; cataloguing and transporting around 33,000
boxes of records for archive in the Netherlands.
“Iron Mountain does a fine job and we have a great relationship,” concludes Sjaco
Baas. “Scan quality and accuracy is excellent. The project is a great example of us
developing our business relationship.”
The Mentor Medical goal is to make life more beautiful; helping patients maintain,
enhance, and restore self-esteem and quality of life. In helping the company attain
the highest quality standards, Iron Mountain can be proud to be part of that.