Solutions & Services
We build validation into our projects and we can build it into yours too. We believe in the integrated life-cycle approach to validation. This means working closely in partnership with you, the end user, to ensure that systems are fully documented and that you have full understanding, and the resulting control.
We firmly believe that validation is not a burden or an added extra, but adds value. This 'common sense' attitude is our approach to validation. We consider validation a key Quality Assurance management tool and something that remains 'alive' throughout the life of systems and processes.
We have the capability to provide 'fully validated' turnkey automation and process technology solutions to industry. Within ProsCon the validation group is independent from the engineering and technology groups. This ensures that validation activities performed under the scope of turnkey projects is fully objective.
We also provide validation services independent of our turnkey automation and process technology solution offerings. We have extensive experience in planning, implementing, and managing all aspects of prospective and retrospective validation projects. We can work with the engineering and/or automation company that you engage to provide all validation services during your project.
We can provide you with a team of engineers to manage and implement the day-to-day activities associated with maintaining your systems in a validated state throughout their life. We can enhance the skills of your team by developing tailor-made validation training solutions to meet your exact needs.
Our Validation team has extensive experience in the following life science areas:
- Bulk Pharmaceutical Chemicals (BPC/API)
- Finished Pharmaceutical Production
- Excipient Manufacture
- Medical Device Industry
Our experience and expertise in the validation of computer systems in regulated industry includes:
- Control Systems (DCS and PLC/SCADA)
- Business Systems (e.g. ERP)
- Laboratory Information Management Systems
- Bespoke software applications
- Manufacturing Execution Systems
- Electronic Batch Records
- 21CFR Part 11 assessments and remediation strategy support
We can assist with, do and/or manage the qualification and commissioning of all your plant equipment, from the initial vendor selection to the production support. We have in-house expertise in the following:
- Filling lines, washers, centrifuges, freezers, lab equipment, autoclaves, compounding equipment, lyophilisers, filter dryers, pan dryers, vacuum skids, USP water generation and distribution systems, clean steam generators, solvent recovery systems, reactors, pilot plants, fermentors, etc.
We have years of experience in the pharmaceutical industry and expert understanding of the processes employed. We offer the following expertise:
- Process Validation — Lyophilisation, fermentation, purification, tabletting, solvent recovery, water / solvent batching, cleanroom qualification, filling, hydrogenation, extraction, etc.
- Sterile Validation — Temperature mapping, bio-kill, filtration, autoclaves, SIP systems, aseptic processing, media processing, etc.
- Cleaning Validation — Sampling techniques, analytical methods, models of contamination, decontamination procedures, CIP, etc.
- We offer a unique solution in that we have a keen understanding of the industry and its regulation.
- Our validation engineers have experience of working with a diverse range of life science companies, and so their knowledge of industry best practice can bring new perspective to your company.
- We have a proven track record in delivering aggressively scheduled projects.
- We are experienced in planning, implementing, and managing risk-based validation projects.
- We will partner with your team to develop a validation strategy which fits your company best.