Staying compliant is a top priority in the pharmaceutical sector and falling out of compliance is not an option.
At PEMAC, we understand that pharmaceutical and medical device manufacturers must adhere to the strict rules such as 21CFR Part 11 set down by regulatory bodies like the Food and Drug Administration (FDA).
Maintenance Teams must meet traceability, authentication and auditing requirements. All vendors must be ISO certified and Maintenance Strategies need to be implemented supporting risk mitigation and continuous improvements. Equipment downtime is a huge additional cost and managing staff and contractors to meet all health and safety standards is key.
PEMAC has a strong history working in the pharmaceutical sector and PEMAC Assets has been developed taking into account our experience with our clients. PEMAC Assets offers you the basic abilities to schedule, plan and track maintenance work orders and hours, while also delivering sophisticated live reporting. PEMAC CARE, our health and safety product, is available and integrated within PEMAC Assets giving you the automated assurance of knowing that contractors & work permits have been issued, the correct and qualified person has been applied to an order, and that all staff are safe while performing maintenance tasks. PEMAC Assets also contains a fully configurable, paperless forms module allowing you to define, control and manage paperless workflows across your facility. This enables you to remove paper from your workflow and alleviate the admin that comes with managing this process.
To support you with a new PEMAC partnership, we have developed a Pre-Qualification Pack significantly reducing your onsite validation time therefore lowering your total cost of ownership (TCO). Once live, our intelligent reporting allows Managers to make better decisions on people, stock and inventory so you can follow LEAN or AMIS Strategies and remain ISO55000 compliant.
Below are some further key features of PEMAC Assets. Speak to us directly for further information.
Key Features
21 CFR Compliance
PEMAC Assets contains auditing, authentication, traceability, automatic lockouts and many other attributes placed as required by this standard.
Calibrations
Ensuring accurate configuration of all instruments to provide sample results within acceptable ranges.
Paperless Forms
Easily configurable Forms approval system removing paper and wet signatures from workflow.
Health & Safety Management
Integrated tool containing Permit management, induction control, EHS event tracking, Risk assessment & contractor management.
Scheduler
Schedule, track and close work orders.
Pre-Qualification Pack
Evidence of the execution of protocols for a specific version of PEMAC Assets reducing the time required for onsite validation.
Stock Control & Inventory Management
Track and manage inventory, asset availability and spares consumption.
E-Learning training certification
Online programme for all staff at all sites to become proficient in PEMAC Assets.
Flexible integrations
Easily integrate with incumbent systems across your organisation such as Meter Reading Systems, OEE and Finance systems such as SAP and Integra.
Reporting and BI Tools
Intelligent and configurable dashboards reporting current and historical Asset Downtime, defect analysis, MTTR, Work Orders, Maintenance cost by asset, Work orders, cost of spares, and hours.
Active Directory SSO
Enables easier sign-on for all staff, less errors.
AMIS/ ISO55000 WorkRate reports
Monitoring and ensuring compliance with standards.
Our Clients
