Meet necessary governance requirements
Regulatory Compliance
Simplify regulatory compliance
Navigating the intricate web of rules, regulations, and updates is paramount for every pharmaceutical company. Regulatory compliance ensures that pharmaceutical products align with the stringent criteria established by governing bodies. BIP365 offers a user-friendly and centralized solution to facilitate your journey towards regulatory compliance.
Regulatory knowledge
Within the pharma industry it’s essential to keep track of regulatory updates, amendments, and new regulations. Which means that it’s important to regularly train and empower teams to with the knowledge needed to make informed decisions.
BIP365 has a built-in Training feature which lets you:
Send one or more documents as for training to a group of users.
Group members will receive a task to read through and electronically sign for their participation to complete the training.
Training managers can view progress and completion rates directly in BIP365.
Automatic reminders are emailed to participants not completing the training within a set time frame.
Risk Management
In an industry where even, the smallest mistake can have great consequences, risk management is nonnegotiable.
BIP365 can replace separate systems for CAPA’s and Deviations by gathering them in one centralized solution with:
Send documents and content for internal and external distribution, review and approval.
With or without electronic signatures.
Pre-configured document templates, workflow, lifecycles and approval chains for CAPA’s and deviations according to the organization.
Easily update lifecycles to match new requirements and implementations to reduce the evaluated risk.
Track changes and results in AI-powered reports. Visualized directly in BIP365!
Documentation & Record-keeping
Every step of the pharmaceutical journey, from pre-clinical to distribution, must be meticulously recorded. These records are the backbone of regulatory compliance and traceability.
Through BIP365 you can:
View detailed audit logs of every document and lifecycle action taken on the platform.
Use pre-configured document templates, lifecycles, and approval chains to maintain regulatory compliance for every user.
Easily update templates, lifecycles, approval chains, and permissions to adhere to new/updated regulations with disrupting current work.
Quality Control
Ensuring the highest level of product/service quality is essential to meet regulatory compliance. This is done by implementing quality control measures and quality assurance processes, which also imbue confidence in consumers and stakeholders.
BIP365 simplifies the challenges with a Quality Management System by centralizing the content and enforcing processes in one solution:
Gather all supporting documentation and content in a Lifecycle set.
Send Lifecycle set with accompanying documents and content to employees for Training.
Share Lifecycle set with accompanying documents and content with internal and external parties directly from the platform. Supporting files sizes of 2GB/each.
Visualize important processes to increase user acceptance.
Easily update document templates, lifecycles, approval chains, and permissions to adhere new/updated requirements with disrupting current work.
Set periodic reminders to review documentation and processes to ensure that the quality is maintained.
Combine Regulatory Compliance with BIP 365 the Intranet to ensure all employees stay compliant by providing quick access to relevant information in their own language!