CMMS Software Qualification Services
PEMAC’s Software Qualification Services Guarantee Completeness, Accuracy, and Compliance
For an uncomplicated validation of your PEMAC ASSETS CMMS software, entrust in PEMAC’s Software Qualification Services.
We guarantee completeness, accuracy, and compliance, giving your team assurance and peace of mind.
Collaborate with PEMAC to safeguard the performance of your solution and achieve exceptional results.
We Make It Easier to Work in Complex and Highly Regulated Industries
Our CMMS software will maximise the reliability, availability, and maintainability of your equipment and assets. The key to this is knowing that your data is always accurate and verifiable – especially when operating in markets that face high regulatory scrutiny.
This is not a ‘fit and forget’ service because we recognise that working conditions are always subject to change. You can trust PEMAC to keep your CMMS software at pace with the latest industry changes.
Our team will provide expert guidance, strategies, and methods to ensure your CMMS software complies with data and system regulations, delivering a fully compliant solution.
How Do PEMAC’s Software Qualification Services Work?
PEMAC understands the importance of accommodating our customers’ challenging manufacturing schedules and regulatory compliance requirements. We prioritise customer satisfaction by allowing businesses to work according to their own schedules and implementing meticulous change management procedures for software modifications. Our Software Qualification Services are tailored to meet the rigorous standards of the life sciences industry.
PEMAC ensures that our CMMS software is fully qualified and compliant, enabling you to streamline operations and deliver high-quality products. Our approach is flexible, supporting clients with existing schedules and carefully planning change management procedures for CMMS software updates.
The benefits of our Software Qualification Services include:
- Thorough qualification processes that follow industry best practices.
- Comprehensive qualification documentation for compliance.
- Effective change management procedures, and expert guidance throughout the qualification process to stay aligned with evolving compliance requirements.
We Know How to Deliver Effective CMMS Software in the Most Demanding Environments
Carefully planned and documented change management processes demonstrate to regulators that validated systems remain in a controlled state after changes have taken effect.
We provide several offerings to support the qualification of PEMAC ASSETS CMMS Software in the life sciences. These include:
Protocol Package
With our Protocol Package, your organisation can confidently navigate the Software Qualification tests for PEMAC ASSETS CMMS software using your own validation staff. By providing clear documentation, alignment with regulations, and traceability between requirements and tests, PEMAC empowers you to achieve compliance, streamline operations, and maintain the highest standards of quality and regulatory adherence.
Our Protocol Package Includes:
- Business Requirements Document (BRD).
- Installation Qualification (IQ) Protocol.
- Operational Qualification (OQ) Protocol.
- Traceability Matrix of Business Requirements Document to Operational Qualification.
- PEMAC Assets CMMS Software 21 CFR Part 11 Assessment.
Pre-Qualification Package
PEMAC’s Pre-Qualification Pack expedites CMMS software qualification for customers in the life sciences industry. It includes IQ and OQ script documentation, a Validation Summary Report, and System Release Configuration, reducing validation efforts by up to 70% while ensuring compliance.
Our Pre-Qualification Package Includes:
Our Pre-Qualification Package Includes:
- IQ Scripts and Results – this documents the setup on a typical server in PEMAC ASSETS CMMS Software.
- OQ Scripts and Results – executes the OQ tests on the same server that the IQ was performed.
- Validation Summary Report (VSR) – summarises the executed validation process, documents any deviations and their remediation, and acts as a final sign-off on the validation of the system.
- System Release Configuration – parameters, set up and configuration used for the OQ tests.
PEMAC’s Experience in Highly Regulated Industries is Second to None
Businesses working in regulated industries need suppliers they can trust. Our Software Qualification Services eliminate uncertainty and give you the confidence needed to continue working unimpeded once your CMMS is live.
What Our Clients Say About Us
At PEMAC, we have vast experience serving clients from a range of tightly regulated industries, including life sciences, food and beverage, chemicals, energy and manufacturing. We understand the unique challenges and specific needs of each industry, and work closely with our clients to tailor solutions for their individual requirements.
As our client testimonials show, this has given us a deep understanding of what’s needed to develop and deliver effective maintenance and asset management solutions.
“We’ve been working with the PEMAC Services team since we implemented PEMAC across our multi-site Scottish operations in 2021. They have been a joy to work with, ensuring we have robust maintenance procedures and processes in place, and making the PEMAC ASSETS CMMS software a cornerstone for LumiraDX in achieving regulatory compliance.”
Liam Mills, Engineering Director, LumiraDx
We Have Transformed Maintenance Strategies Across a Wide Range of Sectors
Our Services Give You Everything Needed to Thrive in a Digitalised Era
Whether you’re just beginning to move maintenance processes online or looking to upgrade your existing system, PEMAC covers all operating scenarios. Our team will understand your requirements and offer one or several services to deliver the most straightforward and effective CMMS solution. These include:
- Project Services
- Optimisation Services
- Business Intelligence Services
- Training Services
- Validation Services
Expert Consultancy and Powerful CMMS Software from a Trusted Supplier
There are many CMMS providers available in the market. But few will have in-depth knowledge and experience in your sector.
PEMAC is different. Our team keeps track of the latest industry trends, issues, and regulatory requirements to build a CMMS that truly transforms the way you work.
Be confident the data you’re seeing is accurate. Work with PEMAC to validate your solution.
