EAM (Enterprise Asset Management) For Life Sciences
Regulated industries - such as pharmaceuticals and biotechnology face a
unique set of challenges to meet compliancy requirements mandated by
regulating agencies. Failure to comply can delay time to market and result
in regulatory fines, plant closings, and lost revenue.
A single, comprehensive solution for streamlining compliance
EAM for Life Sciences provides companies in these sectors with a comprehensive, validated asset
management solution—offering unparalleled security, stability, and configurability—that improves
complex EAM processes to meet regulatory requirements while increasing efficiency and growing
the bottom line.
Enterprise Asset Management solutions for life sciences help you:
- Track, manage, maintain, and extend the life of critical assets
- International Organisation for Standardisation (ISO) standards
- Comply with US Food and Drug Administration (FDA) 21 CFR 11 regulations
- Improve operational productivity and processes
- Increase both equipment and staff productivity
EAM software is a comprehensive, easy-to-use, web-based asset management solution for pharmaceutical
and biotechnology companies that streamlines compliance and reduces its cost. The following additional capabilities are included:
Audit Trails - auditing and tracking tools to ensure FDA accountability with guaranteed accuracy, quality,
and safety for practices, systems, and equipment.
Calibration Software - equipment, instrument, and process calibration, testing, and verification for ISO 9000, FDA, Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and other regulatory standards.
Document Control - access and distribution rights management that safeguards sensitive documents to comply with protocols and procedures, including screening and approval for submissions, reviews, and approvals.
Electronic Signatures - advanced, criteria-based signature controls that can be tailored to operational needs in order to meet regulation requirements and enable an audit trail that shows when a document was altered and by whom.
Preventive Maintenance Revision Control - built-in revision control to help ensure document integrity, protect and preserve documented maintenance procedures.
Record and Data Availability - ability to print and export records in multiple formats, including Microsoft® Excel spreadsheets and Adobe® Acrobat® PDF files, with record library that documents alterations for FDA tracking.
Security - protection that exceeds regulations for authorised use and system access to ensure optimal protection levels against record tampering and malicious attacks.
Call +44 (0)1923 201999 for more details.