SL Controls has a proven track record in applying ‘Validation Compliant Software’ and providing ‘Validation Support’ to some of the largest manufacturing companies in regulated environments.
SL Controls can develop and implement a validation solution, specific to your needs, that will comply with the most rigorous auditing process. We have specialist teams of experienced ‘Validation Engineers’ servicing projects in the Pharmaceutical, Medical Device, Healthcare and Food & Beverage sectors. Our teams comprise of Automation, Integration and Software Development specialists with a depth of experience in each of these sectors. Our policy across all our service areas is to identify the optimum software or support solutions available to support a client project.
The software requirements on our validation projects primarily relate to the following validation software services:
21 CFR Part 11 Compliance Software
Batch Execution Systems
The support requirements on our validation projects primarily relate to the following validation support services:
Source Code Reviews
SL Controls’ Validation Services
SOURCE CODE REVIEWS
We ensure that your source code reviews are carried out in accordance with documented procedures and are performed by an independent reviewer in conjunction with the developer of the code. We have performed source code reviews on multiple platforms and can cater for any customer specific deployments.
When developing and introducing new processes, or making changes to existing processes, you need the expertise to ensure that you meet all the applicable regulatory compliance requirements to your industry. We will provide the expertise to assist you from the requirements, design and qualification phases of the project, through to continued support and re-validation.
Our software validation service consists of Planning, Verification, Testing, Traceability and Configuration management to provide clients with documented evidence that their software is validated. We apply a quality risk management approach to all validation projects to ensure that quality is built into the design from the offset, ensuring that all defects are detected early in the project, delivering significant time and cost savings for companies.
We provide technically experienced Equipment Validation Engineers to qualify your equipment. We can assist you in completing your equipment qualification from initial design stage through to execution of test protocols and generation of reports.
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SL Controls has the ability to provide the bespoke reporting and
visualization each customer requires from their process.