Quality goes hand-in-hand with compliance

Safe and efficacious products are non-negotiable in the pharmaceutical industry. This is why stringent quality standards are laid down by various regulatory bodies. Given the legal and ethical issues involved, it is important to stay compliant with the established quality standards.

Quality issues may occur at any stage of the process such as procurement, intake, manufacturing, packaging, labelling, distribution, etc. Therefore, an overarching framework that can govern the various processes efficiently is a must for quality management.

Why is quality management so critical?

When quality standards are not met, it can result in failure to get approvals, monetary loss, or legal actions. On the other hand, if systems are in place that enable early identification, timely action, and an easy-to-view audit trail, companies can get faster approvals, reduce go-to-market time, and have better customer experience.

The advantages of robust quality management are immense. How can pharmaceutical companies ensure quality to stay compliant? What’s the role of digitalization in this area? Let’s explore.

Technology simplifies quality management

Quality management is an enterprise-wide project. It requires laying down the procedures and policies in line with regulatory requirements, actively monitoring and testing, as well as conducting inspections to check adherence to and efficacy of the protocols.

Manual quality management is time and effort intensive. Moreover, it is harder to keep track of all incidences and interventions done in the processes. This also leads to greater time spent in review and planning the actions. Technology can make the entire process much simpler. For example, electronic records, time stamps, and data flow between applications reduces error in data entry, simplify audit trails, and provide an integrated view of data.

Nearly all aspects of quality management can benefit from digitalization. Below are the 5 priority areas of opportunities:

1. 1) Process digitalization: multiple steps in the pharmaceutical process need to be analyzed and recorded accurately. Applications dealing with quality metrics can effectively record this and also generate trend reports. This leads to easy data access for quality equivalence preparation and results in ease and efficiency of review while saving time and cost.
2. 2) Correction & Prevention: Whenever there are discrepancies such as failures or deviations, technology can be used to systematically investigate these in order to prevent their recurrence. Setting up the relevant applications can support root cause analysis, as well as formulate an action plan to rectify the non-conformance and maintain the required quality.
3. 3) Incident management: Any unplanned actions or undesired outcomes that impact quality need to be recorded for verification, assessment, and audit purposes. Technology enables easy tracking of these incidences, so timely action can be taken and service disruption minimized. Specially designed regulatory-compliant applications have an important role to play here in quality management and compliance.
4. 4) Quality Review: Applications can be deployed to track the complete information of a product during a defined time period, such as manufacturing information, material quality, validation, incidents, etc. This enables companies to understand which processes are under control, and which are in need of corrective action. Applications can also recommend corrective steps to improve product quality, as well as action for continued process health.
5. 5) Market complaints: Products of compromised quality result in customer complaints. Timely reviewing and addressing of these complaints are important. Applications make this process structured, enabling companies to tackle these complaints in the order of criticality. This leads to a better understanding of quality gaps, implementation of required improvements, and compliance with regulations.

Quality management is not a one-time activity, but rather a continuum where continuous evaluation and improvement are required. Technology has a crucial role to play in making it easier for companies to meet regulatory quality standards.