As per FDA, compliant electronic signatures must include:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
Ref. FDA 21 CFR PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
The Sarbanes-Oxley act (SOX) is designed to combat financial crime with culpability placed as it tends to be in a corporate structure.
Review of corporate internal controls should address controls around information security.
Does LQATS give all users unique login credentials?
LQATS ensures that nobody can log on to the system without uniquely identifiable credentials.
Yes. When a supplier or any other defined user logs into LQATS, documents that have been flagged to be available to the user will be shown on the opening form. Users may view and download the document(s) to their local workstation. As users download files, a log is updated within LQATS that may be displayed to appropriate system users. For auditors, a product specification document may be shown during the audit process. Measurement and tolerance metrics are recorded in LQATS and compliance is automatically determined.
Yes. Each supplier who is allowed access to LQATS will see only information that they have entered or changed. Specific supplier reports may be designed for suppliers to use, or they may use any other common system reports depending upon how a system administrator has configured their permissions. Still, only information specific to the supplier may be viewed by the supplier. In addition, suppliers may download specific files, i.e., product specs, previously assigned by an authorized user or system administrator.
Yes. An unlimited number of AQL values may be used in the quality audit process. In addition, new AQL values may be mapped to user-defined sample size tables to automatically determine pass/fail limits for an audited product.
Lyons Information Systems, Inc.® has created a proprietary process to hasten the return of data in reports and queries. The process eliminates session timeouts while awaiting a report or query. The process becomes even more valuable as the amount of data grows large and the numbers of users increases.
With a roles-based security and permissions system, each user is mapped to a role based upon the types of tasks that the user will perform inside of the system. These may be changed at any time. Once the roles are established for users i.e., staff, suppliers, inter-company sites, etc., then each user is assigned to an individual role. A user may only be assigned to one role. Each role defines a user’s access to reports, menu items, types of quality functions that may be performed, etc.
1. Affordability: we offer a unique pricing model that allows procurement of LQATS ,or any of our systems, at a minimal customer price.
2. Global view of real-time quality performance at company production sites.
3. No seat licensing requirements.
4. No limit to the number of production sites that may use the system.
5.Managed by the customer.
6. Supports hosted and non-hosted environments
7. Imports data from external database systems
8. Built on non-proprietary technologies