GMP Software with 21 CFR Part 11 Compliance

Ensuring Regulatory Compliance in Pharmaceutical Manufacturing

More so than most industries, there is considerable risk in pharmaceutical manufacturing due to non-compliance with federal regulations. Each step of a process is regulated and must be appropriately documented. But bringing life sciences products to market is a journey that is fraught with potential for errors. With so many teams, individuals, partners and supply chains involved throughout production, maintaining compliance from start to finish is a significant challenge.

Guidance for regulatory requirements in the pharmaceutical industry are outlined within the GMP regulations for the US and EU. FDA 21 CFR Part 11 in the US and EU Annex 11 deal specifically with electronic records and signatures in pharmaceutical manufacturing. 

Compliant manufacturing processes must be able to successfully adopt the following:

Support evidence of appropriate authorization and supervisory protocols

Document process activities and quality management

Include robust processes for identifying performance or quality issues and taking preventive or corrective action where necessary

Errors at any stage can lead to production delays or products not fit for use. Consistency is absolutely key in an industry that has such potential to impact on human life.

In an age where precision in manufacturing is far more achievable than ever before, embracing the available solutions in line with guidelines laid down by Pharma 4.0 is essential for all companies in validated industries.

The digital transformation offers new and innovative processes, such solutions must serve their purpose in a compliant manner. In an industry which cannot tolerate room for ambiguity, compliance to these regulations must be built into a system’s design and function.

Paper-based forms have many drawbacks, but data leakage is rarely an issue. As the industry moves towards IIoT, it is faced with new challenges in terms of data security. Compliance, while becoming tighter, has also been made more complex.

Data protection is now a key component of GMP in a way that it hasn’t been previously. It is essential that companies within the industry find a way to balance digitized and automated processes with strict compliance laws. Getting this balance right will result in increased productivity, greater batch consistency and fewer compliance issues.

One of the major issues facing pharmaceutical companies when it comes to batch accuracy is the complexity of their manufacturing processes. Precision and consistency are key for product efficacy and safety. But with complex processes comes increased opportunity for errors. These errors can lead to manufacturing delays, production and quality losses, and costly compliance breaches. Review by exception and computer assisted review can provide remedial action to take place before expensive mistakes are made to ensure production remains efficient and compliant.

Despite the regulatory risks associated with data entry errors and audit trails, many in the pharmaceutical industry are still relying on paper records and manual data entry, putting their operation at risk. Digital logbooks can be authored to ensure every step of the process is recorded and every batch has a simple audit trail. 

OpsTrakker helps improve productivity and reduce expenditure while ensuring regulatory compliance.

OpsTrakker’s eLogbook, eForms and eBR solutions eliminate human error, standardize manufacturing processes and improve efficiency from formulation to production.

Configurable sign-offs enable streamlined execution of time-sensitive activities across regions. Wet signatures are no longer a pain point to production and can enable greater digitalization ambitions. 

Biometric authorization also makes authorization of documents and adds an extra layer of security with fingerprint recognition.

Likewise, the review by exception function reduces unnecessary review time. By automating the review process, only those elements that need to be reviewed are highlighted. This speeds up the review process and allows reviewers the time to focus fully on those areas that have been highlighted as in need of review. 

Electronic logbooks and forms with mandatory fields ensure every box is completed and that the entire audit trail is legible, date and time-stamped and easily accessible for review or audit.

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