Virtual GMP Design Office

How does it work?

Our processes ensure that your company is audit compliant at all times. We can help develop audit readiness inspection packs, master drawing racks and we can also help digitize your files. We have our own internal SOP for drawing, document and model management to ensure regulatory compliance and we can also help your teams adapt to a new or modified SOP to ensure complete audit compliance at all times. All of our files are revision controlled, with full audit trail available on superseded information. We use the latest applications available to achieve a streamlined approach to GMP drawing, document and model management.

Each client has their own internal Drawing System Owner, this person will have full visibility and must approve all update requests, this gives you full control on what work is carried out, ensuring full transparency with workloads and also providing a dashboard metric of hours spent and what projects/ departments they were spent on.

The Procedure

All workflows are backed up by our own Standard Operating Procedure (SOP) that dictates the process for updates, we can modify this to suit your process whilst remaining compliant with the application workflow and most importantly, compliant with all GMP regulatory requirements.

We have over 20 years of experience managing drawings & documents within a GMP environment. We can help you prepare the necessary files for GMP audits. Helping you develop a straight forward process to manage all regulatory inspections and walkdowns of GMP drawings.

You can outsource your BIM and drawing management to us. We can maintain any model/drawing format in any application. We will work with your project and operations teams to ensure a robust and concise BIM turnover. We can work hand-in-hand with your training and development teams to create interactive AR or VR
training simulations for complex processes.

Our GMP VDO services include; Architectural, Mechanical, Electrical and Piping drawing/model modifications (& design). All of our modifications to your information is verified by our own in-house Quality Review, this means that you will get the right information and help ensure accuracy when final approval is made by your QA teams for GMP drawings & models. All backed up by our own in-house SOP that has been developed to ensure full GMP control over all modifications & new designs.

The Benefits

Reduce Costs and Increase Efficiency

We can utilize the latest versions of applications out there to create a process for your company, or, we could use our own proprietary software to manage and maintain the information for you.

We will ensure that your teams can share, remove, approve, create and collaborate on multiple projects. View all regulatory required drawings within a GMP environment, so you are always ready for inspections!

Request instant feedback and gain immediate access at the click of a button. Remain fully compliant to all regulatory guidelines while experiencing full team and company wide transparency for increased work flow, improved quality, and instantly achieve and expand productivity goals.

Why Our

Solution

Hard Copy Master GMP & Site Saftey Drawings

We can help maintain your hard copy master drawings (audit master drawing file) and ensure all superseded revisions are securely stored, scanned to PDF and available for any regulatory inspections. We can also provide all hard copies of any drawing and maintain the updates to those drawings for you. All within a controlled GMP environment.

We can also help you develop “Site Safety Drawings”, in the event of a mass evacuation, we can provide your teams with hard copy safety drawings to access from outside your main building.

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Have Any Questions?

Thank you very much for your interest in our company and our services and if you have any questions, please write us a message now!