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Paperless Conversions for Medical Device Manufacturers

Are rows of filing cabinets and towering stacks of forms part of your day-to-day?

The internet, computerization, and the huge number of identified diseases, conditions, and drugs to treat them have complicated the medical device world. Medical and pharmaceutical manufacturers are facing an ever-increasing slew of forms, requirements, documents, and revisions. Managing this paper mound the conventional way is becoming near impossible.

This shift is prompting more manufacturers to go paperless, which involves two overarching steps: converting existing and internal records to digital, and receiving new records in a digital format.

Sundial can provide references, case studies, and testimonials on successfully transitioning Medical Device companies document storage and intake systems to effective, cost-saving digital systems.

It is a default consideration for any medical device storage system that security and access control are utmost concerns. Our entire business revolves around working with highly-regulated manufacturers and any system we implement comes with strong security. Each of our med device testimonials can speak to the security and effective access controls of implemented systems.

Converting Existing Records to Digital and EDMS Systems

Medical and Pharmaceutical manufacturers may be considering converting records, and record management systems, to digital at the same time. A company may have a large number of SOPs, FMEAs, CAPAs, NCRs, Training Documentation, Equipment files, Engineering change records, Validations, Test Reports, and other documents they wish to track digitally, or simply store digitally.

When considering what documents to take digital, and how, it is important to weigh ROI. It may be nice to track 10 years of documents digitally in an EDMS system, but poor ROI may result from the transition if old documents are rarely accessed or referenced.

Consulting is required up-front to decide which records will go to an EDMS system, and which will simply be stored digitally. Once this break-point is determined, companies must additionally decide how records will be stored digitally.

Companies may be satisfied with nothing more than Windows SMB or Samba file shares that are only accessible by the Quality department – in this mode Quality Records are living in a highly-available archive format. Most companies that transition to an EDMS do not want older records available outside of the Quality department, to prevent other departments from making changes or revisions to old documents.

Other companies may desire to continue to track changes and revisions to older documents, or may have some doc types they are in the process of phasing out. These organizations may want to pursue a local or Cloud version of Microsoft Sharepoint where they can utilize Sharepoint’s built-in version control and audit trails. Sharepoint’s excellent permissions system can be integrated with most business networks and access to Quality documents can be restricted as necessary.

The goals of any paperless conversion for standing records to save money and storage space on document management and increase accountability and record keeping. Careful upfront planning along with a project-oriented mindset will maximize these goals while keeping internal salary-cost-hours down.

Converting to Digital Intake Methods

Medical and pharmaceutical manufacturers have internal Quality systems that rely on documents, and revisions, to track quality and operations within the business. Most manufacturers also have a steady stream of outside documents coming into the company from other manufacturers, field reps, and study participants.

Many of these documents, especially those completed by doctors or nurses participating in studies, are completed on hand-written forms, then scanned, and then converted to digital by an on-staff quality professional. Some of the forms may be unreadable, poorly scanned, or difficult to archive due to missing data fields. The time spent processing these incoming forms can be unlimited as the business grows.

Most manufacturers, when converting docs to digital, will also desire to convert their incoming forms and outside participatory documents to a digital format that meshes well with incoming storage. This typically starts with a very secure intake format – web forms that have required fields and data entry points. These forms are then converted to PDFs that are then deposited into the companies document storage system in compliance with necessary permission and access controls.

Having a form be implemented into a site, then seamlessly sent to necessary file repositories can save huge amounts of time for quality departments leading to a lower cost of quality and ultimate higher business operating level and profit potential.

FAQ

Is converting records to digital safe?

In our experience, as long as proper access controls and permissions are set, it is about as likely that an unwanted employee or contractor will access digital copies of records as they are to physically break into a file cabinet.

Records are best stored on an isolated server where access is provided only to appropriate Quality and Regulatory professionals. This limits exposure to downloaded malware.

Can we store all of our records in the cloud?

It is now possible to move operations and storage of any volume to the cloud – it is just a matter of cost. Cost of cloud storage for high volumes of regularly accessed documents can be considerable. This can be weighed in advance.

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