Paragon Audit supports MDSAP – breakthrough for the medical industry

The introduction of a Medical Device Single Audit Program, MDSAP for short, meets the desire of the countless medical device manufacturers for a uniform approach to audits and inspections across national borders.

Advantages of Paragon Audit:

• Structured implementation of MDSAP audits also possible without auditor training
• More than one MDSAP checklist
• ISO 13485 can be carried out as a single management audit
• User dialogue for defining and linking primary and support processes (one-time effort – approx. 30min)
• Audit along the process chain, remain flexible in the sequence at any time
• Direct auditing based on requirements (ISO13485 and country-specific)
• Risk-based auditing according to MDSAP requirements, including Grading rules
• Audit plan, audit report, action plan and data analytics at the touch of a finger
• Time savings of up to 90% for follow-up and preparation

Based on our cooperation with our customer Amann Girrbach, we serve auditing according to the MDSAP standard as the first app on the market worldwide.

In addition, auditing according to IOS 13485, which forms the basis for MDSAP, can also be carried out. This enables companies to carry out the relevant Stage 1 and Stage 2 audits, the result of which is the successful implementation of MDSAP.

The Basis

Auditing according to MDSAP is based on the dependencies of the processes. The results of a development process determine the requirements for a manufacturing process, and so on. This is where Paragon Audit, with its clear structure and flexibility of audit planning, comes into its own. No more paper and pencil or redundant data entry.

The starting point for an MDSAP audit is the company processes, which are configured once in the app. With the help of a self-explanatory user dialogue, the specific requirements of the MDSAP are added.

It is important to note that MDSAP distinguishes between four primary processes and three support processes.

Primary processes are:

• Management
• Measurement, Analysis and Improvement
• Design and Development
• Production and Service Controls

Supporting processes are:

• Purchasing
• Device Marketing Authorisation and Facility
• Registration
• Medical Device Adverse Events and Advisory Notices Reporting

Here, too, the advantage of Paragon Audit is obvious: the definition of processes and their characteristics, including process owners, is child’s play.
Linking the requirements from the respective standard is done within seconds.

Uniform and risk-based

The basis for each audit carried out with Paragon Audit is always in the same structure and follows a uniform logic.

The country-specific requirements of the MDSAP pose a significant challenge for auditors. Within Paragon Audit, these requirements are individually selected, specifically assessed and answered. Through visual support, the auditor always has a full overview of the requirements and their processing status.

Risk-based auditing, as MDSAP requires of auditors, is in the DNA of Paragon Audit. The direct assessment of risks for each audit finding is done on a logical scale. The scale translates risk both visually and in binary.

Our clients are faced with a dilemma as they have to take into account the assessment logic from MDSAP as well as to ISO 13485. With the help of Paragon, this point is easier than ever, the tedious conversion is done automatically.

With the help of Paragon Audit’s data analysis, we support our customers’ desire for a structured and simple way to present risks transparently. Thus, at the touch of a finger, the risk from the audit documentation is translated into data analytic dashboards.

Action plan and audit report – at a fingertip

Action plan and audit report – at the touch of a button

Who doesn’t know it as an auditor – after the audit is before the audit! Countless hours are lost in the preparation of the audit report, gaps in the documentation or lost documents make your work more difficult.

Paragon Audit puts an end to tedious post-processing here, too, as the data is recorded directly on the Ipad.
The audit report is created within seconds at the touch of a finger, including a signature on the cover sheet by the auditor and auditee – fully digital, of course!

The action plan appears on your Ipad at the same speed as the audit report and is already structured in the common formats.

Sending the documents from the app – naturally included!

Actions portal for auditees

In addition to the audit module, the Paragon Action Portal takes a central place in the seamless communication between the auditor and the auditee. There is no longer any need for Excel lists or other tracking solutions.

Using state of the art cloud technology, measures are synchronised in real time, regardless of location. Our cloud portal brings together the open tasks of an audit for each process owner, whether they sit internally or externally. This gives the team the advantage of clear structures and transparency in the processing of open items. The auditor can complete his tasks conveniently and quickly from the app.

The automatic documentation of changes to submitted measures provides transparency and a quick recording of changes. Preset rules, according to standard, pre-schedule the implementation of measures and thus help auditees and auditors to meet deadlines.