User Access Management System for Life Sciences

Corporate security relies greatly on User Access Management. A US FDA 483 Observation for Pharmaceutical and Biotech Companies may be issued in GMP environments if illegal access authorization is granted to application software and instrument software.

User Access Management System

 

The number of automated applications continues to increase in the Life Sciences Industry. Among these various software packages are ERP, LIMS, LMS, QMS, DMS, eBMR, eLogs, and Chromeleon, to mention just a few. Several Cloud solutions are also available to them along with on-premise ones. It is not uncommon for major corporations to have between 100 and 200 software applications.

It’s difficult to keep track of users, access permissions, role updates, license utilization, and compliance. Many leading pharmaceutical and biotech firms still use paper-based requests for access management. In the present-day manual procedures, unsafe access-related issues including duplicate identities, illegal access, limited or no validation of pre-requisites for access provisioning, absence of audit trails for access assignments, and other difficulties lead to major vulnerabilities. Identity and access management for users cannot be centrally managed.

Assuring regulatory compliance and ensuring a smooth audit process can be made easier by providing a reliable system that can oversee, maintain, and manage user access permissions for the workforce, as well as track management authorizations for exceptions.

According to data, more than 40% of user access rights are still in place after an account has been terminated. Inability to revoke access puts the firm open to attack (especially for SAAS applications) and makes it difficult to effectively employ User Licenses.

AmpleLogic User Access Management Software, commonly known as identity and access management (IAM), is written in LOW CODE. It aids in the provisioning and management of users’ access to internal and external apps, as well as third-party SAAS permissions, based on their function and designation.

Using this software, IT managers can ensure that their employees have safe and secure access to the organization’s services and facilities. A Universal Directory allows this to happen.

User Access and Permission Management Software ensures that your organization’s security regulations are followed. It is linked to the Active Directory. AmpleLogic Identity and Access Management Software integrates seamlessly with SAP, HRMS, and Active Directory or LDAP.

Challenges with Manual User Management, Access Privileges in Pharma and Biotech Companies

Manual User Access Requests
  • Filling out hardcopy documents that must be signed and authorized by several administrators is time-consuming, tedious, and prone to mistakes.
  • Manual requests will take longer than normal owing to the time it takes to transfer paper by hand.
Tracking of large volumes of End User Access Requests:
  • It becomes nearly impossible to keep track of the number of users who have sought new accounts, terminated their subscriptions, or requested updates to their access permissions.
The difficulty of Managing several software licenses:
  • The vast majority of software applications are licensed on a per-user basis.
  • When an employee leaves, their licenses expire.
  • It’s difficult to make good use of end-user licensing. It’s hard to keep track of and update the list of expired end-user licenses across the organization.
Inappropriate Account Closure
  • Erroneous deactivations of user access.
  • Poses a threat to the security of the system and requires an extra licensing fee.
An unnecessary complication of the on-boarding and off-boarding process:
  • The manual approach makes it difficult to deal with multiple account activations or deactivations when employees join or leave the organization.

User Access Management Software Features

Application and License Manager
  • User licenses for software are stored in a database.
  • It is easy to manage the roles and permissions of users across all of your available software.
User Life Cycle Management
  • Automate the process of bringing on and removing users.
  • Active Directory is automatically populated with data from the SAP/HR System for new employees.
Electronic Access Requests
  • The web-based software can be used to make any requests for software or instruments.
  • It saves time by removing the need for manual form filling.
Secure Audit Trials
  • Produces a comprehensive user audit trail report with e-signature.
  • Creates a unique report of a user’s duties in a software or a tool.
Changes in Role Permissions:
  • Different permission levels can be set dependent on the organizational structure
User Access Permission Reports
  • You can automatically generate a report showing how many software/instruments a person has access to using User Access and Permission Management Software.
  • This program generates reports at the plant level that may be used to identify plant-specific software and plant-specific personnel. It also provides information on active and inactive users on a plant-by-plant basis.
Account Deactivation Instantaneously:
  • Sends an email notification to system administrators when a task is scheduled for deactivation.
  • Aids in software and instrument license management.
Managing Compliance Over Time:
  • AmpleLogic User Permissions Management Software adheres to all policies and laws specified by regulatory agencies such as the FDA 21 CFR Part 11, the MHRA, ISO, the EU Annex 11, and other national and international standards

Advantages of User Access Management Software

Enhanced Efficiency
  • Responds quicker and efficiently to users’ needs, while also providing better service
24*7 Accessibility
  • It is accessible from any system at any time
Data Security
  • Ensures the data security of information stored in electronic form
Cost Reduction
  • It increases the companies’ cost-efficiency
  • It makes employees more productive
  • It ensures adherence to legal and regulatory requirements
  • It automates admins’ time-consuming tasks
  • Licenses will be used efficiently

Additionally, AmpleLogic Identity Access Management Software complies with electronic record standards established by the TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.

Other industries that can take advantage of User Permissions Management Software
  • Biologics
  • Medical Devices
  • Contract Development and Manufacturing(CDMO)
  • Chemical Industry
  • Contract Manufacturing
  • General Manufacturing
  • Contract Research Organization (CRO)
  • Food & Beverages

f you would like to learn more about how AmpleLogic Pharmaceutical Identity and Access Management Solution may assist your company, please get in touch with us.

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