Sholto Hesketh examines how the right software solution can guarantee optimum quality control in the pharmaceuticals industry
When it comes to the pharmaceutical sector, quality control really can be a matter of life or death, with the slightest error resulting in potentially catastrophic consequences. With an ever increasing list of legislative, regulatory and consumer requirements to comply with, the cost of non-compliance or sub-standard quality control processes is not just financial. Far-reaching repercussions can affect business reputation, consumer trust and ultimately, the survival of the business.
Pharmaceutical manufacturers face the challenge of effectively demonstrating their commitment to quality control, providing evidence of accurate, repeatable processes and procedures, reducing their risk of non-compliance. But many pharmaceutical businesses are still reliant on outdated, inefficient and manual processes to track, monitor and record the relevant quality information. Where technology is used, it’s often through a combination of creaking, legacy systems which, for such a crucial part of the business, is far from best practice and definitely does not guarantee stringent and accurate quality controls.
Where some pharma manufacturers are leading the way is through the use of software which manages all relevant manufacturing processes, control and authorisations, not only supporting regulatory compliance and quality assurance, but providing real business efficiencies throughout the organisation. Rather than a bolting together of manual and automated processes, managed via a variety of different systems, a holistic approach ensures that technology has the ability to guarantee quality in the pharmaceutical sector.
One solution across the business provides the ability to amalgamate information from all aspects of the production process, avoiding any errors in the transference of data from one system to the next, or one spreadsheet to the next, and results in a comprehensive, accurate audit trail. Not only does this make it easier for organisations to demonstrate compliance, but it enhances performance, while reducing risk through enhanced traceability management. With such systems in place, quality is guaranteed, but with the added bonus of a business better prepared to anticipate, analyse and respond to market demand.
Sector specific solutions handle all the relevant quality requirements too, including FDA and MHRA accountability, as well as ISO standards, and advanced signature controls are built in too for 21 CFR 11 compliance. For an industry which often deals with the smallest amounts of ingredients, precision is crucial, something that’s been recognised by certain software developers. The right solution will provide the granular level of detail that’s required by the industry, automating the ability to quickly and accurately scale-up formulas for example, all the while guaranteeing a precise bill of manufacturing. Improved document management is another often neglected part of the quality process and again, something that the right solution can control. By ensuring the right records are not only kept, but kept somewhere that they be readily and easily searched and accessed, the best solutions underpin the entire quality control efforts of the business, providing a visible and accessible audit trail.
If quality processes and procedures are slow, unwieldy and inaccurate, the knock-on effects on production can be numerous. For example, when it comes to overall production efficiency and planning, production can even come to a halt, with repeat batches of particular products not possible if the first batch doesn’t meet the necessary quality checks. With the right solution in place, there’s a positive effect on not only production efficiency but the efficiency of the business as a whole. With an end-to-end solution keeping track of every step of the manufacturing process, providing real business insight, in real time, it’s possible to identify when things aren’t going quite to plan, enabling the business to put plans in place to ensure errors don’t turn into catastrophes.
This concept is only set to become more commonplace, with the advent of Industry 4.0 providing greater efficiency in modern manufacturing by way of increased interconnectivity of business processes and equipment, providing a highly visible and transparent workflow across the supply chain. For example, informing operators (in real time) about conditions of their lines, notifying them of faults straight away, enables corrective action to be taken before any disruptions to production occur. For those pharmaceutical manufacturers who are already considering making better use of technology to improve their quality control, now really is the time to invest. By putting the right solutions in place now, you can be ready to embrace the new levels of transparency and efficiency that Industry 4.0 will unlock.
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