Our Services #7385858

Total Laboratory Services Ltd can carry out laboratory equipment validation for lab machinery (both old and new) across quality control and analytical workrooms within the pharmaceutical, academic and life science industry. Our skilled engineers have many years experience performing laboratory validation, along with calibration, repairs and maintenance, and are qualified to perform all validation tests to current USP standards. We provide laboratory equipment validation to all laboratories that perform quality control and sample analysis where USP compliance is stipulated. We can easily validate TOC, Stability Chamber, HPLC, GC, LC, Mass Spectrophotometer, tablet hardness, dissolution and disintegration testers, as well as some other analytical devices too (but please check with us first). Apart from adhering to compliance, laboratory equipment validation is also very important because it confirms that your pharmacopeia apparatus is producing the correct data expected from analytical tests. Our equipment validation can help confirm your tool and machinerys output, making the likelihood of wrong data and unsuccessful tests far less probable. Laboratory equipment validation can also reduce your machine down time because problems that require consideration are often noticed during the validation process.

At ARIZONA, our compliance consultants have a strong working knowledge of requirements and can help implement the necessary quality systems to meet the regulations. Additionally, we have substantial experience helping clients with remediation when their quality systems implementation and management fall short of meeting regulatory requirements. We provide GMP consulting to proactively help our clients avoid issues with regulatory agencies. GMP consulting is often performed by a gap assessment of the current quality systems and determining if there are any observations that expose them to enhanced regulatory scrutiny. ARIZONA then provides recommendations for remediation and will provide hands-on support with the implementation of remediation activities, as necessary. We also provide a set of solutions unique to regulatory challenges faced by compounding pharmacies, including qualification and validation, response and remediation support like FDA 483s, warning letters, Drug Quality and Security Act (DQSA) assessment, compliance audits for USP and cGMP training. ARIZONA compliance services augment our clients internal capabilities to prepare for, execute and address compliance-related observations and deficiencies, thus mitigating our clients regulatory risk.

Excel is the universal standard for data handling and data processing and the vast majority of companies use Excel for handling regulatory data. Demonstrating that your spreadsheets are functioning correctly and produce accurate data is critical not only for your own business processes, but also for satisfying your regulatory auditors. If you cannot show with documented test evidence that spreadsheets are generating the correct data, then your auditors can stop the use of your Excel spreadsheets or worse still stop your operations until the situation is resolved. CSV offer a complete service to validate your spreadsheets and provide documented evidence of their correct functionality. The process is designed to maximise efficiency and focuses on repeatability for your whole inventory. Detailed user requirements and specifications ensure that your spreadsheets are designed to meet their needs. Comprehensive qualification testing to demonstrate correct functionality coupled with evidence that the operation is secure and maintained within a recorded environment. Validation Service BenefitsContinue the use of Excel, with your current spreadsheets and trained users and satisfy your regulatory auditors. Complete confidence in your spreadsheet outputs both for regulatory compliance and operational accuracy. An off the shelf documentation set, configurable for your own quality system and already proven in the top pharmaceutical companies worldwide. Receive a turn key solution from the world leaders in spreadsheet validation and developed with assistance from the FDA.

OEM Services

System Integrity Services

Retrofitting Services

Panel Design Services

Panel Maintenance Services