Ensure quality and compliance in life science productions
Regulatory bodies and agencies (Ministries, AIFA, EMEA, FDA, etc.) require the ability to track changes to the process and ensure compliance with the good manufacturing practices (GMP) used: it follows that manufacturers are looking for ways to make sure the process has not been tampered with without the necessary approvals.
MDT AutoSave is designed to ensure this compliance: it becomes part of the infrastructure for change management, approval and control. MDT Autosave tracks all changes on PLCs, HMIs, documents, workstations and more can ensure proper control and notification of changes. This can be invaluable in knowing if changes have been made to the software, why, and by whom. In addition to providing rollback and recovery data in case of device failures, the software periodically polls automation devices and compares the code running in the processor with the latest version stored on the backup server (in addition to managing all backups and the versions). If a mismatch is discovered (which could indicate that someone went around our system and made a change), a notification is sent to key personnel highlighting the mismatch and information to track the changes.
To further increase the level of change control, MDT AutoSave also provides an approval workflow and electronic signature functionality in support of 21CFR11 guidelines and regulation.
https://www.youtube.com/watch?v=X6LrjC-Jq5U&list=PL7sPYUlI_Z5Ho1SZ00ea50XpuZnpoSnqn
WHITE PAPER ON CHANGE MANAGEMENT AND CONFIGURATION CONTROL:
The strategic importance of system reliability
Change Management in the Pharmaceutical
Change Control in Life Sciences
Electronic Approval & Management Audit Trail
MDT AutoSave Software is also designed for the electronic approval and management control required in highly regulated environments. Now, workflows and approvals can be managed electronically, greatly simplifying the review process.
Features include: electronically signed approvals, multiple stages of review, verification and confirmation processes, additional security features (password control, log messages, configurable approval messages, and more).
This feature set can be enabled on devices that require a formal change process, allowing access to user-defined user groups for review and approval. As a change progresses through the review process, its status is updated to indicate that the change has been reviewed. Approved changes can be downloaded for testing, and only after validation can they be "put into production". All activity is logged, and some reports can be generated on demand to show activity and status changes.
MDT Autosave is used by a number of major life science manufacturers
A partial list of AutoSave MDT customers includes: Abbott Nutrition, Hospira Inc., Arla Foods, Johnson & Johnson, BASF Chemical, Merck & Co., Proctor & Gamble, Bristol-Meyers Squibb, Wrigley, Nestlè Purina, Tsb Sugar, 3M, Eli-Lilly, American Sugar, C&H Sugar, Coca- Cola, Ingredion, Medica-Go, Patheon, Purac Biochem, Rich Products, Santa Cruz Nutritionals, Synlait, Lyle & Tate Sugars Ltd, …
White Papers and Case Histories:
Change management for life sciences
Change Management & Control at Airport
Change control in Food&Beverage