Protect Trade Secrets When Collaborating With Your Supply Chain Partners

Sharing PHI, clinical trial data, drug research, and intellectual property is highly risky for pharmaceutical and life sciences companies. This information is also often subject to regulations that require rigorous controls.

The Kiteworks Private Data Network consolidates email, file sharing, SFTP, MFT, and web forms, so every file sent, shared, or received is controlled, protected, tracked, and recorded in adherence to rigorous standards and regulations like HIPAA, GxP, ISO 27001, Cyber Essentials Plus, NIST CSF, and more.

Protecting Critical IP in Drug Discovery, Trials, and Manufacturing

Pharmaceutical companies often need to share sensitive information related to drug discovery and clinical trials. Insecure file sharing can lead to data breaches and loss of critical intellectual property. Kiteworks provides a secure file sharing platform that allows companies to share sensitive information related to drug discovery and clinical trials securely. The platform’s encryption, access controls, and version control features ensure data integrity, confidentiality, and protection of critical intellectual property.

Secure File Sharing for Genome Sequencing

Pharmaceutical and biotech companies often need to share sensitive genome sequencing data. Insecure file sharing can lead to data breaches and loss of intellectual property. Kiteworks provides a secure file sharing platform that allows companies to share sensitive genome sequencing data securely. The platform’s encryption, access controls, and version control features ensure data integrity, confidentiality, and protection of intellectual property.

Secure Communication for Clinical Trials

Pharmaceutical companies often need to share sensitive patient data during clinical trials. Insecure communication can lead to data breaches and noncompliance with privacy regulations. Kiteworks provides a secure communication platform that allows pharmaceutical companies to share sensitive patient data securely. The platform’s encryption, access controls, and audit logging features ensure data integrity, confidentiality, and compliance with privacy regulations such as PIPEDA, GDPR, CCPA, HIPAA, PDPA, and others.

Secure File Sharing for Research Collaboration

Pharmaceutical companies often need to share sensitive research data for collaborative projects. Insecure file sharing can lead to data breaches and loss of intellectual property. Kiteworks provides a secure file sharing platform that allows pharmaceutical companies to share sensitive research data securely. The platform’s encryption, access controls, and version control features ensure data integrity, confidentiality, and protection of intellectual property.

Managed File Transfer for Regulatory Submissions

Pharmaceutical companies often need to transfer large files for regulatory submissions. Traditional file transfer methods can be slow, unreliable, and insecure. Kiteworks provides a managed file transfer solution that allows pharmaceutical companies to transfer large files quickly, reliably, and securely. The platform’s high-speed transfer, reliability, and security features ensure efficient and secure file transfer.

Secure Web Forms for Patient Recruitment

Pharmaceutical companies often need to collect sensitive personal information for patient recruitment. Insecure data collection can lead to data breaches and noncompliance with privacy regulations. Kiteworks provides secure web forms that allow pharmaceutical companies to collect sensitive personal information securely. The platform’s encryption, access controls, and audit logging features ensure data integrity, confidentiality, and compliance with privacy regulations such as GDPR, PIPEDA, PDPA, HIPAA, and others.

Email Security for Internal Communication

Pharmaceutical companies often need to share sensitive information via email. Insecure email communication can lead to data breaches and noncompliance with privacy regulations. Kiteworks provides email security features that allow pharmaceutical companies to share sensitive information via email securely. The platform’s encryption, access controls, and audit logging features ensure data integrity, confidentiality, and compliance with privacy regulations.

Secure File Sharing for Manufacturing Processes

Pharmaceutical companies often need to share sensitive manufacturing process data. Insecure file sharing can lead to data breaches and loss of intellectual property. Kiteworks provides a secure file sharing platform that allows pharmaceutical companies to share sensitive manufacturing process data securely. The platform’s encryption, access controls, and version control features ensure data integrity, confidentiality, and protection of intellectual property and compliance with GxP regulations.

Managed File Transfer for Supply Chain Management

Pharmaceutical companies often need to transfer large files for supply chain management. Traditional file transfer methods can be slow, unreliable, and insecure. Kiteworks provides a managed file transfer solution that allows pharmaceutical companies to transfer large files quickly, reliably, and securely for supply chain management. The platform’s high-speed transfer, reliability, and security features ensure efficient and secure file transfer.

Secure Web Forms for Adverse Event Reporting

Pharmaceutical companies often need to collect sensitive personal information for adverse event reporting. Insecure data collection can lead to data breaches and noncompliance with privacy regulations. Kiteworks provides secure web forms that allow pharmaceutical companies to collect sensitive personal information securely for adverse event reporting. The platform’s encryption, access controls, and audit logging features ensure data integrity, confidentiality, and compliance with privacy regulations such as HIPAA and GDPR.

Email Security for External Communication

Pharmaceutical companies often need to share sensitive information with external partners via email. Insecure email communication can lead to data breaches and noncompliance with privacy regulations. Kiteworks provides email security features that allow pharmaceutical companies to share sensitive information with external partners via email securely. The platform’s encryption, access controls, and audit logging features ensure data integrity, confidentiality, and compliance with privacy regulations.

Secure File Sharing for Patent Applications

Pharmaceutical companies often need to share sensitive patent application data. Insecure file sharing can lead to data breaches and loss of intellectual property. Kiteworks provides a secure file sharing platform that allows pharmaceutical companies to share sensitive patent application data securely. The platform’s encryption, access controls, and version control features ensure data integrity, confidentiality, and protection of intellectual property.

Managed File Transfer for Data Backup

Pharmaceutical companies often need to transfer large files for data backup. Traditional file transfer methods can be slow, unreliable, and insecure. Kiteworks provides a managed file transfer solution that allows pharmaceutical companies to transfer large files quickly, reliably, and securely for data backup. The platform’s high-speed transfer, reliability, and security features ensure efficient and secure file transfer.

Secure Web Forms for Customer Feedback

Pharmaceutical companies often need to collect sensitive personal information for customer feedback. Insecure data collection can lead to data breaches and noncompliance with privacy regulations. Kiteworks provides secure web forms that allow pharmaceutical companies to collect sensitive personal information securely for customer feedback. The platform’s encryption, access controls, and audit logging features ensure data integrity, confidentiality, and compliance with privacy regulations such as GDPR, PIPEDA, PDPA, HIPAA, CCPA, and others.

Secure File Sharing for Quality Assurance

Pharmaceutical companies often need to share sensitive quality assurance data. Insecure file sharing can lead to data breaches and loss of intellectual property. Kiteworks provides a secure file sharing platform that allows pharmaceutical companies to share sensitive quality assurance data securely and in compliance with GxP regulations. The platform’s encryption, access controls, and version control features ensure data integrity, confidentiality, and protection of intellectual property.

Managed File Transfer for Data Migration

Pharmaceutical companies often need to transfer large files for data migration. Traditional file transfer methods can be slow, unreliable, and insecure. Kiteworks provides a managed file transfer solution that allows pharmaceutical companies to transfer large files quickly, reliably, and securely for data migration. The platform’s high-speed transfer, reliability, and security features ensure efficient and secure file transfer.

Secure Web Forms for Patient Consent

Pharmaceutical companies often need to collect sensitive personal information for patient consent. Insecure data collection can lead to data breaches and noncompliance with privacy regulations. Kiteworks provides secure web forms that allow pharmaceutical companies to collect sensitive personal information securely for patient consent. The platform’s encryption, access controls, and audit logging features ensure data integrity, confidentiality, and compliance with privacy regulations such as GDPR, PDPA, PIPEDA, HIPAA, DPA 2018, and others.

Frequently Asked Questions

GxP is a general term for “good practice” quality guidelines and regulations, primarily used in the pharmaceutical, medical device, and food industries. The “x” in GxP can be replaced with various letters to denote specific types of good practices. Here are the most common examples:

GMP (Good Manufacturing Practice): Guidelines for the manufacturing, testing, and quality assurance of products to ensure they are safe and effective
GLP (Good Laboratory Practice): Standards for non-clinical laboratory studies that ensure the consistency, reliability, and quality of the results.
GLP (Good Laboratory Practice): Standards for non-clinical laboratory studies that ensure the consistency, reliability, and quality of the results.

These guidelines ensure that products are produced and controlled consistently, meeting quality standards appropriate for their intended use and regulatory compliance.

GxP guidelines do not explicitly cover cybersecurity, as they are primarily focused on ensuring the quality, safety, and efficacy of products through good practices in manufacturing, laboratory, and clinical processes. Nevertheless, cybersecurity is inherently relevant to GxP compliance because protecting the integrity, confidentiality, and availability of data is crucial to GxP compliance. Examples of cybersecurity practices or uses of cybersecurity technologies that align with GxP include:

Data Integrity: Ensuring the accuracy and consistency of data throughout its lifecycle helps organizations protect data from unauthorized access, alterations, and loss.
Electronic Records and Signatures (ERES): Regulations like 21 CFR Part 11 in the US specify requirements for electronic records and electronic signatures, which include cybersecurity measures to ensure data integrity and security.
Risk Management: Implementing robust cybersecurity practices like multi-factor authentication (MFA), incident response plan, encryption, and granular access controls are essential for compliance with GxP guidelines.
Audit Trails: Capturing and recording who accesses, edits, shares, sends, or receives files containing intellectual property (IP), personally identifiable or protected health information (PII/PHI) ensures these and other file activities are tracked and traceable in comprehensive audit logs, which is a requirement under GxP for accountability and transparency.

Yes, the FDA requires GxP compliance for the industries it regulates, particularly in the pharmaceutical, biotechnology, and medical device sectors. GxP guidelines ensure that products are safe, meet their intended use, and adhere to quality standards. The FDA conducts inspections and audits to ensure that organizations adhere to GxP standards. These following GxP components apply to FDA regulations: Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Distribution Practices (GDP), and Good Pharmacovigilance Practices (GVP).

Compliance with these GxP guidelines is critical for obtaining and maintaining FDA approval for products, ensuring public safety, and avoiding legal and financial penalties.

The terms “bio sciences” and “life sciences” are often used interchangeably, but there are subtle differences in their scope and emphasis. Bio sciences, or biological sciences, typically refers to the study of living organisms and their interactions with the environment. Key areas include: molecular biology, microbiology, genetics, biochemistry, and cell biology. Life sciences, by contrast, is a broader term that integrates biological sciences with related fields to understand life from a holistic perspective. Key areas include: bio sciences, biomedical sciences, environmental sciences, agricultural sciences, biotechnology, and neuroscience.

Both fields of study receive public and private sector funding, utilize cutting edge technology, and develop critical research. As a result they process, share, and store massive amounts of sensitive information that must be protected to protect personally identifiable and protected health information (PII/PHI) and intellectual property (IP) to maintain a competitive edge and demonstrate regulatory compliance with data privacy laws and standards like GxP.

Pharma and life sciences organizations handle a variety of sensitive content that must be protected to ensure compliance with regulations, maintain patient confidentiality, and safeguard proprietary information. Key types of sensitive content include: personally identifiable or protected health information (PII/PHI), clinical trial data, intellectual property (IP), research and development (R&D) data, patents and trade secrets, FDA or EMA filings, compliance documentation, supply chain data, financial statements, contracts, and more.

Protecting this sensitive content is essential to maintain trust, ensure regulatory compliance, and protect an organization’s competitive edge. This typically involves implementing robust cybersecurity measures like: access controls, end-to-end encryption, and strict adherence to industry regulations and standards like GxP.