Maintaining a top-functioning Quality System in regulated pharma environments can add serious problems to the company’s bottom line.  Nevertheless, the ROI can be significant with solutions that automate routine and administrative tasks related to Quality System maintenance.

Within the pharmaceutical industry, it is not easy to find a Quality System model that offers a meeting point for agreement, be it direct or indirect, with the FDA’s cGMP initiative, 21 CFR Parts 210 and 211 regulations, the FDA’s Critical Path Initiative, ISO 9000 standards, and/or the requisites of foreign regulatory bodies.

However, in the ‘Quality Systems Approach to Pharmaceutical cGMP Regulations’ support document, the FDA introduces a potential Quality Systems model that could offer the elements that pharmaceutical companies require to start, or keep on, growing a top-functioning Quality System capable of meeting the institution’s regulations and requisites.

The quality systems model proposed by the FDA is divided into four major categories:

1.Management responsibilities
3.Manufacturing operations
4.Evaluation activities

Here, we’ll discuss the first category, Management Responsibilities, and how many administrative chores related to pharmaceutical Quality Systems management could be automated.

According to the Quality System model proposed by the FDA, management staff in pharmaceutical environments has two main responsibilities:

-First responsibility: “Senior management must show commitment to developing and maintaining their Quality System.”
Developing a Quality System is a task that takes time and requires dedication.

Even if a quality manager knows a lot about the difficulties and particulars of different Quality System models, he or she will most definitely have to show commitment to developing the Quality System itself.

The management staff also holds the responsibility of maintaining the Quality System.  There are five stages linked to Quality System maintenance:

1.Observation of the Quality System
2.Identification of deviations and nonconformance events
5.Appropriate action

Management has to be accountable for every stage of Quality System maintenance and normally will hold the biggest responsibility in regards to data analysis and later decision making.

In spite of this, it is common to see managers spending most of their energy on the first three levels, which are the ones that pose the heaviest burden and are also the ones that are perfect for automation.

The benefits of automation are very clear:

_More time for analysis and associated research
_Less administrative responsibility

There are software options that act as an “observer” of the company’s quality system, and with these, quality management staff in regulated pharmaceutical environments can benefit from the advantages of automation.

These solutions should offer data and trending technology that simplify the identification of Quality System deviations and nonconformance events, as well as sophisticated auditing capabilities, and should allow for the effortless creation of reports that show data trends.

With good automation technology in place, management will still hold the major responsibilities in regards to Quality System maintenance, but timely and uninteresting administrative chores disappear from the picture.

-Second responsibility: “Quality System plans should be aligned with a manufacturer’s strategic plans to ensure that the system is part of the manufacturer’s mission and quality strategies.”
A Quality System is not an entity unto itself, it meddles in everyone’s business, and this is why it is crucial that the Quality System be linked to other pharmaceutical systems and processes’ goals and realities.

Nevertheless, it may not be easy to line up Quality System management with the other processes and departments because these have a tendency to be disorganized and subjective.

Good automation will let pharma companies connect quality, compliance, and everyday routine processes with solutions that take-off from one platform.  This sole platform offers two benefits:

-Faster and more effective communication between departments
-Less quality system errors due to manufacturing and quality disconnects

Within pharmaceuticals, the aspects of management responsibility seem countless, but there are modern quality management solutions that have been designed to consolidate and greatly simplify the job of pharma management staff.

Your pharmaceutical consulting firm has powerful inside information to guide your choice of quality management solutions for your company.  They are there to help you make the right choices!

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