Regulatory bodies like the FDA must enforce compliance regulations for pharmaceutical and life sciences companies. Some new regulations are more stringent than others, and compliance regulations imposed globally by the FDA are usually more quality-focused.
Key factors that drive compliance and regulation changes include patients (in relation to adverse events or reactions), emerging markets, technological developments, as well as globalization. These changes require pharma companies to readjust the way they run their operations and they need to take advantage of the best compliance reporting software to accommodate and tackle the changes imposed on them. With report generation software like Windward, companies can now avoid non-compliance issues and minimize any negative impact quite effectively in real time.
Big and small firms within this industry are persuaded to follow the compliance rules governing the quality of their products by the need to:
• Stay abreast of market standards
• Close observation by regulating bodies
• Considerable repercussions (that come with overlooking the rules)
• Minimize the organization’s exposure (brand image) and
• Optimizing the cost of complying
It is crucial for companies to come up with a solid compliance strategy by identification, reporting, analysis, and mitigation of any compliance-related risks.
Unfortunately, outdated IT infrastructure in most pharma companies present disparities in the platforms and systems used for reporting (over 40% believe that their present compliance reporting and monitoring systems don’t provide any encouraging intervention). This makes access, integration, and analysis of data problematic, thereby making a comprehensive understanding of compliance issues difficult and things can get out of control.
In fact, compliance heads in most pharma companies are depending on manual reporting software that is absolutely time-consuming, resource-intensive, and painfully complex.
Compliance reporting can be simplified by engaging report automation software like Windward to draw data from different data sources. The best part about report automation software is that even an individual employee of your firm can design templates with unlimited parameters and conditional logic functionality in familiar platforms like MS Office and generate hundreds of compliance reports in a matter of minutes. After this, they can share them in multiple output formats with relevant authorities.
Focusing on the aforementioned strategies offers companies within the pharma and life sciences industries a chance to walk the balance between value gained and costs averted when it comes to compliance risks.