The criticality of compliance for life sciences

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Before selling pharmaceutical or medical products in any country, manufacturing companies must prove regulatory compliance and approval within the country their products will be distributed. By remaining compliant, medicines are manufactured per each country’s pre-defined and approved specifications to ensure the delivery of safe and effective products to their consumers.

With mandates in place, how do manufacturing facilities ensure they meet compliance expectations?


By effectively monitoring environmental factors that can impact product quality and assessing the data integrity of batch records due to human error risks.

Non-compliance can be devastating for a business. Not only can it cause major delays in a product’s release, but in some cases, it can lead to a product batch being destroyed.

The dominion of data

Regulatory requirements help ensure medicines are safe for consumption. Plant data is instrumental in fact-checking product compliance, and data integrity further creates trust between regulators, manufacturers, and in turn, consumers.

However, as necessary as data is, it has ironically been sighted as one of the top concerns related to regulators issuing observation notices and warning letters. The FDA cited data as the cause of 79% of the Drug Warning Letters over the last five years.

Clear data presentation is paramount when regulators conduct on-site inspections. Facilities can be asked to provide documented records of:

  • Environmental monitoring
  • Personnel interaction with systems of record
  • The order in which events occurred

Data quality affords manufacturers visibility of past and presents records to prove they have met certain specifications and standards. These records must be readily available for auditing, and failing regulatory audits can ultimately result in a license withdrawal.

Any missing or inaccurate data can lead to non-conformance and often results in hefty fines and license suspension or removal – a scenario costly to any business, no matter the size.

Cybersecurity and non-conformance

As cybersecurity has dominated headlines, it’s no surprise it has impacted the world of medicinal product manufacturing, which can affect non-conformance. Two-thirds of pharmaceutical companies have suffered serious data breaches due to hackers, with the cost impact running into the millions.

A weak defense against external and internal cyber-attacks can more easily enable hackers to:

  • Access to key networks
  • Capture intellectual property (IP) data
  • Compromise data integrity
  • Interrupt facility operations
  • Hold a corporation to ransom.

Additionally, by failing to protect data adequately and, as a result, becoming victims of cyber-attack, manufacturers may be in breach of GDPR, which can lead to supply issues or product recalls. On top of this, frequent cyber-attacks erode partner and consumer trust, ultimately deteriorating brand reputation.

A poor cyber defense infiltrates almost all business aspects. A solid cybersecurity defense must be considered a significant part of a business’s compliance strategy. As well as protecting a business from ransomware, it doubles up as an opportunity for conformance – protecting businesses all around.

How digital technology can support compliance

In an industry that requires strict precision and accuracy, human error represents the biggest risk to quality control.

Digitizing operating procedures has the benefit of not relying on human input and can have a positive impact on quality control:

  • Workflow management solutions help correctly guide employees to follow the right steps.
  • Digitizing document validation processes saves time, helps adhere to regulatory requirements, and promotes data integrity.
  • Helps ensure complete traceability throughout the lifecycle
  • A SaaS platform integration makes data validation faster by employing a more agile methodology.
  • Improved document accessibility for regulatory bodies who support digital transformation and are modifying their activities to accommodate this through audit guidelines.

The transformation of paper records to paperless digital systems has immense benefits for the industry. A non-compliance scenario can be highly disruptive, requiring a great amount of time, effort, and cost for a plant to recover from – and revert to – its licensed state.

As the industry increases the adoption of Pharma 4.0, digital technology enables companies to comply with minimal effort and maximum effect.

To learn more, access our Life Sciences website or download our new e-book, “Turning risks into opportunities for Life Sciences.”

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