End User Access Management in Life Sciences Industry
User Access Management is at the heart of corporate security. In GMP environments, Improper Access permission to the Application software and Instrument software may lead to a US FDA 483 Observations for Pharmaceutical and Biotech Companies
In the Lifesciences Industry the number of automated applications keep growing. To name a few ERP, LIMS, LMS,QMS, DMS, eBMR, eLogs, Chromeleon software programs and many more. In addition to on premise solutions, they have access to multiple Cloud solutions too. In a large scale organization, the number of software applications can range from 100 to 200.
Managing the Users, Access Permissions, Role Updates, License utilization and compliance is challenging. Today access management in leading Pharmaceutical and Biotech companies relies on paper based requests. The current manual processes result in risky access-related issues such as duplicate identities, unauthorized access, limited or no validation of pre-requisites for access provisioning, absent audit trails for access assignments and other matters that create significant security concerns. There is no one place to manage user identities and access.
Providing a robust system which can monitor, maintain and manage user access privileges for the workforce, keep a track of management approvals for exceptions, and document information on who has accessed what date and when the data was accessed, can go a long way to easing the burden of regulatory compliance and ensuring a smooth audit process.
Research shows that over 40% of user access rights are not removed upon termination. Not revoking access, leaves the company vulnerable (Specifically SAAS Applications) and leads to ineffective use of User Licenses.
AmpleLogic User Access Management software, also known as identity and access management (IAM) is developed on LOW CODE PLATFORM. It helps in the providing permissions and administration of individual users and their access to Internal Applications, external applications and third party SAAS permissions based on their role and Designation.
The software enables IT administrators to provide secure access of the organization’s services and features for the company’s workforce. This is achieved simply within a Universal Directory.
User Access and Permissions management ensure compliance with your organization’s security policies. It is Integrated with the Active Directory. End User management software can easily integrate with SAP, HRMS and with the Active Directory or LDAP.
Challenges with Manual User Management, Access Privileges in Pharmaceutical & Biotech Companies
Manual User Access Requests
- The process of filling physical forms which are signed and approved by different administrators is tiresome, time consuming and error prone.
- Manual Requests will take time due to manual movement of paper
Tracking of large of volumes of End User Access Requests
- Tracking the number of users requested for new account creation, termination or updating the access permissions based on previous approvals becomes extremely difficult.
Complexity in managing various software licenses
- Majority of the software programs come with user-based licenses
- Termination of user licenses during employee separation
- Effective utilization of end user licenses is challenging. It is difficult to track and maintain the list of end user licenses across the enterprise which nearing their expiry date and time
Improper Account Termination
- Unreliable access deactivations.
- Poses security risks and additional license costs.
Redundant On-Boarding and Off-Boarding Process
- Due to slow manual process, whenever employees are joining or leaving the organisation, it will become difficult to handle multiple account activation or deactivation requests.
Identity and Access Management Software Features
Application and License Manager
- Data base of the Software applications and their User licenses
- Easily manage the user roles and permissions across all accessible software.
User Life Cycle Management
- Automate user on-boarding and off-boarding process.
- Auto Populates the New joinee’s data from SAP/HR System into active directory.
Electronic Access Requests
- All requests for a software/instrument can be placed through the Web based software.
- Saves time by eliminating manual form filling.
Secure Audit Trials
- Generates a complete user audit trial report with e-signatures.
- Generates a dynamic report showing the roles of a user in a software/instrument.
Role Permission Changes
- Allows different levels of permissions based on levels of hierarchy.
Access User Access Permission Reports
- Auto-generates a report displaying the number of software’s/instruments that the user has access to.
- Generates reports on the plant level which can help in identifying information related to plant-wise accessible software, and plant-wise employees. It also shares details of the activated and deactivated users on a plant-wise basis.
Instant Account Deactivation
- Generates an email alert for deactivation task to system admins.
- Helps in managing licenses of software and instruments.
Sustained Compliance Management
- Complies with all policies and regulations outlined by regulatory authorities like FDA 21 CFR Part 11, MHRA, ISO, EU Annex 11 and other national and international standards.
User Access Management Software benefits
- Improve response time, user service, and increase efficiency, etc
- 24×7 accessibility and can be accessed anytime from any system.
- Ensures data Security of the information contained in the electronic form.
- Improves cost efficiency for the organizations
- Higher productivity among employees
- Better compliance with regulatory policies
- Automation of repetitive tasks performed by admins
- Effective Utilization of Licenses
AmpleLogic Identity Access Management Software will also comply with electronic Record standards defined by 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
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages