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Paperless Good Manufacturing Practice (GMP) Audits

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Manufacturers must have in place a quality assurance system to ensure that finished goods and products are fit for their intended use; These quality assurance guidelines provide minimum requirements that a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public. Every manufacturer is responsible for monitoring their GMP compliance. Good manufacturing practices, are overseen by regulatory agencies in the United States, Canada, Australia, Europe, China, and other countries

Existing paper-based GMP inspections and audits practices have some short-comings- GMP auditors/ inspectors may find paper-based tools for data collection cumbersome and inconvenient. The traditional clipboard or notebook and pen are not always conducive to detailed note-taking. This form of documentation also renders picture-taking, an invaluable resource when escalation is necessary, effectively unavailable.

The popularity of smart phones and tablets has changed the corporate and industrials markets with an estimated over 140 million monthly global activations of mobile devices at the beginning of 2016. Managing GMP audits has become more efficient with the introduction of mobile devices. As mobile devices become smarter and more advanced, they are increasingly being used to automate audits and inspections. Mobile devices (e.g. iPads, tablets smart phones) featuring cameras, barcodes, and/or RFID scanners facilitate the accurate identification of audit and inspection targets and areas so findings, results, recommendations, notes and any other related media are consistently attributed to the correct entry every time. The mobile devices are lightweight, widely available, and easy to operate and pre-programmed with customized/tailored GMP paperless checklists. The mobile devices accommodate traditional written notes as well as the integral use of mobile device features including the camera and barcode scanning capabilities, Near Field Communication (NFC) for accommodation of RFID tags, speech-to-text translation and automatic capture of date/time/GPS. Results recorded during the GMP audit/inspection using the mobile devices are transmitted electronically and stored either in secure data centres or locally in-house by the user.

With the paperless GMP inspection application, an auditor or inspector can:

– Use their current Smartphone or tablet (Android or iOS);

– Enter data using pick lists, or speech to text;

– Take photos using the in-built camera;

– Annotate (“doodle”) the photos taken;

– Capture electronic signature;

– Access to reference material, standards and images while off-line;

– Send completed GMP audit back to the office in real time;

– Generate reports on the spot and send to the relevant stakeholders

A paperless GMP solution should be highly-customizable and allows tailoring the GMP audit to each manufacturing or distribution sites based on the manufacturer guidelines.

The paperless GMP inspection solutions promote competent work-flow, as well as its trigger engines are designed to ensure that periodic GMP audits are not overlooked. Automated email reminders and notifications improve compliance by ensuring that GMP objectives and principles are always met on a timely basis. The automatic alerts can remind of up-coming GMP audit, and can be customized to escalate overdue or incomplete GMP audits to relevant stakeholders in a timely manner. Furthermore, features, such as corrective action module ensures that the information needed to rectify a deficiency, a hazard or failed inspection is easily accessible at all times and is proactively sent to the responsible stakeholders for addressing these deficiencies. These escalation and corrective action features are instrumental in ensuring closed-loop work-flow for any GMP audit.

Paperless or electronic GMP solutions are further enhanced via the use of web portal which can be accessed from any web browser including mobile browsers. The web portal’s features include system administration, report generation, automatic notifications, trend analysis and other metrics, data-exporting/importing and the ability to customize automatic alerts and emails. The end result is a completely automated paperless GMP process encompassing mobile devices and web portals.

The intangible benefits of paperless GMP inspection work-flow are countless.

Paperless GMP Inspection solutions promote efficiency by providing highly organized records and improving auditor/inspector accountability and personal ownership. Most importantly, it keeps workplaces safer and companies compliant with industry safety standards. By conducting GMP audits at all manufacturing and distribution sites the manufacturer comply with registration requirements and do not place users at risk due to inadequate quality, safety or efficacy.

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