DIGITISATION AND DATA INTEGRITY IN MEDICAL GASES
The digitisation of business processes is becoming increasingly important for companies in the Medical and Pharma field. The technological changes that have taken place in recent years, with an ever-increasing demand for digitized processes and rigorous real-time information, together with regulatory requirements, are turning the computerization of processes and the validation of computerized systems into strategic and necessary actions for any company.
The integrity of the data generated, processed, represented and stored in these systems has vital importance.
ALCOA+ rule requirements
The main requirements of data integrity compliance with FDA and European Current Good Manufacturing Practice (CGMP) regulations are centralized in the ALCOA+ rule. Initially, each letter of the word ALCOA represented a requirement that the information had to meet (Attributable, Legible, Contemporaneous, Original and Accurate). Later, the requirements were expanded by adding the + symbol to the word ALCOA: data must also be complete, consistent, enduring and available.
The impact of incidents on data recording and integrity can be very significant in regulated industries such as Medical and Pharma companies. If it affects the product, it can lead to non-conformities and sanctions. These deviations can have a huge economic impact.
Data integrity solution
The APT Aries MGS system, paired with proprietary XGAS® Software, meets both the increasing demand of computerized systems and the integrity of measured data.
APT Aries MGS are automatic analysis systems that can set measurements at multiple points of the plant: from the ASU column to the filling station, up to the flow control of reducing valves. All the technologies proposed have been successfully tested over the years and are compliant with current legislations, including the European Pharmacopoeia, the EU-GMP and FDA regulations.
The whole system is completely managed by proprietary XGAS® software, for the acquisition of analytical results, to control the analysis process and to produce the final report. XGAS® stores all measured data, for a complete traceability of lots, strictly following the ALCOA+ rule.
XGAS® is installed on a panel PC built in the cabinet and on a tablet and aims to make a complex analytic system easier, with specific routines that enable a simpler management with the purpose of remove systematic mistakes during operation. The measured data are recorded as observed, there is no human error. Our system has a high level of automation, so users can get away from using paper.
Increasing data security means having the possibility to store all results and activities on the company network. APT Aries MGS system, complete with XGAS® software, has been conceived and continuously improved to guarantee the formal integrity of measurements and measured data, offering complete traceability of every activity performed, for every access level.
The Panel PC and the tablet can be connected to the net, allowing data exchange with the customer ERP system. APT ARIES MGS and XGAS® software are both validated for pharmaceutical applications and for use in the medical field.
Digitisation is also about problem solving: APT Aries MGS guarantees to customer complete remote assistance through a standard VPN connection: it permits to know all the relevant diagnostic information which allows to really quickly and easily offer solutions to solve the issue. Very often, with this approach it’s possible to avoid the site visit and, if the visit is necessary, the technician comes much better prepared for whatever the issue is.
Conclusions
The digitisation megatrend has been well discussed in recent years and continues to be both a talking point and a future game-changer in the operations of the medical and industrial gases industry. APT, by constantly challenge the engineering staff to gain knowledge and experience, aims to take the leading position in the market.
