Scanning vital production files ensures compliance for mentor medical

Customer Success Stories

Scanning vital production files ensures compliance for Mentor Medical.

19 February 20188 mins
Mentor Medical Case Study

Scanning vital production files ensures compliance for Mentor Medical.

INDUSTRY:

Healthcare

CHALLENGE:

Digitisation of batch records to improve data access

SOLUTION:

Document scanning and offsite records management

VALUE:
  • Access to vital files in seconds rather than days
  • Improved operational efficiency
  • Simplified and accelerated compliance processes

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 accessto working copies of vital records inseconds rather than days."

Sjaco Baas
Site Records Manager
Mentor Medical

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 onfull-scale digitisation of the Mentor Medical records archive. Over the next monthsIron Mountain created more than 1.6 million PDF images, made available via a secureportal for download into the Mentor Medical document management system.

Now the back-catalogue has been fully digitised, new batch records are routinelycollated and sent for scanning. Each month Iron Mountain collects and scans around20 boxes of files, creating around 50,000 PDF images for download within a 10-daytimeframe. Once scanned the original paper files are archived, to remain available ifever required; for example, in the unlikely event of a legal enquiry.

"Having our batch records available in digital form means we have access to workingcopies of vital records in seconds rather than days," says Sjaco Baas. "It's just a farmore effective and efficient way to work."

Developing a strong business relationship

The association between Mentor Medical and Iron Mountain continues to evolve. Forexample, Iron Mountain recently supported the company following the closure ofa manufacturing facility in Mauritius; cataloguing and transporting around 33,000boxes of records for archive in the Netherlands.

"Iron Mountain does a fine job and we have a great relationship," concludes SjacoBaas. "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 attainthe highest quality standards, Iron Mountain can be proud to be part of that.

"The site visit helped us visualise the process as well as confirm iron mountain safety and security provisions at first hand."

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