Almac Clinical Services is delighted to notify you of a number of enhancements to your overall customer experience.
Our aim is to make Almac easy to work with, flexible, innovative and efficient – to reduce the burden on you, our customer. Relentless in our pursuit of operational excellence, we’d like to present the initial projects under this initiative.
We aim to improve processes and procedures without compromising on GXP or compliance, whilst streamlining and simplifying the delivery of your projects. Let’s take a closer look at these below.
For more information, you can contact us directly.
Reducing Documentation:
1. Streamlined Quotations
We have reduced the volume of fixed text in our quotes by 50%, keeping the budget to the forefront. The Executive Summary section of the quote remains, with an additional section providing an overview of services, capturing all study related information and assumptions made from the customer RFP. All necessary terms and conditions remain.
2. Opt-out of Doc Approvals
Almac is pleased to give you, our customer, the option to opt-out of Almac document review and approval. Our documents are generated from your source documentation and all documents are independently approved by experienced staff. Independent review is completed against the customer source documentation and much of the information is Almac derived. Benefits: reduces lead times, removes duplication of effort across multiple documents – saving you time and money.
3. Streamlined Batch Records
Enhancing the structures and processes you are already familiar with, we have significantly reduced the scale and complexity of our Batch Records. Benefits: tailored documents responding to your needs, clear instructions for operational staff and reduced effort to review and approve – saving you time and money.
4. Quality Investigations
We have streamlined our quality investigation process and reports, removing the requirement for customer approval. Benefits: reports will focus on the essential details to arrive at true root cause and generate effective CAPAs to reduce repeat deviations: omitting long, complex descriptions of our processes.
Implementing Electronic Documentation:
5. Docusign®
In order to increase efficiencies and enhance your user experience in obtaining signature approvals, we have implemented a product for the electronic approval of documentation – Docusign®. Benefits: CFR Part 11 module that has additional security around user authentication to ensure compliance, electronic web-based platform allowing users to sign a document electronically instead of using handwritten/wet signatures, increasing efficiencies while providing a paperless and secure user experience – saving you time and money.
6. True Copy
Intelligent workflow solution that utilises Optical Character Recognition (OCR) and an e-signature capture capability, to electronically verify and store documentation in a secure environment, all while maintaining GxP and data integrity compliance. Benefits: provides assurance when making GxP decisions from electronic documents, reduces your company’s ecological footprint and removes the need to retain hard copies, – saving you time and money.
7. Label Approval System (LAS)
Understanding your needs we have applied our expertise to supply you with the most advanced and user friendly label approval system in the industry. Benefits: enables you to directly access, review and mark-up master label text and support regulatory translation, all whilst ensuring GxP and data integrity compliance. Benefits: improved timeline management, task notifications, email reminders of overdue approvals, built in workflows, full audit trails of comments and approvals – ensuring clinical labels that are regulatory compliant, country specific and right first time – saving you time and money.