A Virtual Data Room can streamline the regulatory audit process even as it adds significant safeguards that protect confidential and proprietary documents and data files:
Centralized Data Repository: A VDR serves as a secure and centralized location to store all relevant documents and data required for the audit. Having all this data in one place makes it easier for the biotech firm to assemble the necessary documents and for auditors to access the information they require.
ShareVault is the preferred VDR provider for the Biotechnology Innovation Organization (BIO), the leading global trade association for the biotech industry.
Secure Data Storage: A virtual data room provides a highly secure environment for storing documents for regulatory review, as well large numbers of supporting documents. Stored documents can include regulatory submissions, clinical trial data, research reports, manufacturing procedure records, quality control documentation, intellectual property information, and other critical documents.
- Documents stored on a ShareVault VDR protect patient health information (PHI) and are 21 CFR Part 11 Compliant.
- When regulatory submissions are required, ShareVault’s secure VDR is the preferred platform for sharing Electronic Trial Master Files (ETMF), Investigational New Drug (IND) applications, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologics License Applications (BLA), Drug Master Files (DMF), Biologics Master Files (BMF) Emergency Use Authorizations (EUA), and other requisite submissions.
Data Integrity and Authenticity: A biotech product proposal includes large numbers of data files and documents that are subject to review during an audit. To protect the integrity of these files, a virtual data room provides multiple document security features.
- ShareVault automatically encrypts every document with 256-bit encryption at upload
- Additional ShareVault protections include document watermarks and the ability to shred documents remotely, even after they have been downloaded
Controlled Access: Access controls are necessary to protect the confidential documents in the VDR environment. Only authorized individuals are allowed access during the product development stage and subsequent audit review.
- With ShareVault, the VDR administrator sets up strict access controls to protect the VDR for in-house use with an internal team and in their collaborations with remote third-party subject matter experts, and then extended to the regulatory team during an audit
- ShareVault access protocols include multi-factor authentication (MFA) passwords and role-based access control (RBAC) that restrict a user’s activities to specific actions, such as read-only, print, share, and download.
Easy Accessibility: Regulatory audits involve multiple stakeholders, from the internal teams who generate and organize primary and supportive documents to the regulatory authorities who perform the audit. With a virtual data room, all authorized parties can access the necessary documents and information at any time, and from any location. This accessibility streamlines the audit process, reduces delays, and allows for efficient collaboration among all involved parties.
Version Control: Version control features allow the biotech firm to track changes and access previous versions of documents in their preparation for their product proposal. During an audit, regulators may ask to see previous versions of documents to explore how and why certain features of the proposed product were generated.
Real-Time Communication: During product development and preparation for an audit, the biotech team can use communication tools to pose questions to designated experts. These real-time tools streamline the back-and-forth communication that is common during product development and regulatory audits. ShareVault’s Q&A tool can be used not only by the internal team, but also by regulators to question assumptions or claims during the audit process.
Audit Trail: A quality virtual data room provider includes software that generates an audit trail that logs all user activities. An audit trail provides an additional layer of transparency and accountability during the regulatory audit process. ShareVault’s user activity monitoring creates a granular record of all activity, by date, time and user: sign-in/signoff, document uploads and downloads, views, and actions taken with a document or data file, such as print, revise, download.
Time and Cost Efficiency: Using a virtual data room to conduct a regulatory audit can significantly reduce the time and cost associated with traditional paper-based audits. It eliminates the need for physical document handling, printing, and courier services.
Use a ShareVault VDR to Secure and Streamline the Audit Process
A virtual data room (VDR) provides enterprise-grade security for confidential documents and data files used in critical biotech projects: product development, regulatory audits, partnership agreements, and financial projects like mergers & acquisitions (M&A). By leveraging the features of a leading VDR provider, a biotech firm can enhance data security, streamline the audit process, and demonstrate their commitment to compliance and transparency to regulatory authorities.
ShareVault: A Secure and Cost-effective Solution
A ShareVault virtual data room is the perfect platform for protecting and streamlining the biotech development process and the attendant regulatory audits.
Since each biotech company has its unique needs, ShareVault pricing is based on the feature sets most important to you. Whatever choice you make, you have the protection of a 30-day money-back guarantee. To receive a customized ShareVault proposal, contact us today!