• Site Info
  • About PCS
  • About Ian Sykes
  • About René Maassen
  • About Wilma Meijs
  • About Jaap Koster
  • Customer Profile
• Training Services
  • External Training
  • In-House Training
• Cooperation
  • Facilities
  • Equipment
  • Training
  • Drug Development
  • Quality Systems
  • Regulatory Affairs
  • Process Validation
  • Ongoing Support
• Contact

 

Ongoing Support

"Good Project Delivery" will significantly reduce and control the ongoing support costs, including maintenance, regulatory compliance and operations effectiveness - production delivery. On the other hand, "Bad Project Delivery" - often the least cost alternative - does exactly the opposite.

It is still vitally important to plan for ongoing support activities as part of the project. HPCS Quality Systems Support will deliver the documented systems for Operation and Maintenance Procedures and practices. In addition to this ?set up? support, we provide:-

Troubleshooting Support

Our team of engineers and scientists cover all disciplines required for pharmaceutical manufacture and process control. Therefore ,we are very well placed to assist in any troubleshooting activities. Unlike the equipment vendors, we can take an holistic view and identify the root causes of problems, rather than just looking for a quick / temporary fix. We are generally able to get an engineer or technical specialist to site the next day to assist in times of urgent need.

Change Control and Continuous Compliance

Changes to processes and equipment are inevitable during the life of a process, either because of obsolescence or the need for process / capacity improvements. We can help manage this change process, assess the requirements, control the work and requalify / revalidate as necessary following the change. Again, our range of technical expertise and disciplines ensures we have the skills necessary to assess and manage the change and implications.

Requalification

 The need for requalification may be driven by regulatory changes, site/equipment changes or just loss of confidence in the process and existing validation. We can both deliver engineering and technical resources to complete the requalification, and also manage the whole process from definition through to documentation and delivery.

Audit and Inspection

We perform a range of audits, from pre-inspection readiness audits looking at the overall process and quality systems, to specific equipment audits targeted at compliance or supportability in a certain area. The scope of the audit is clearly defined up front, with deliverables agreed. Typical audits include:-

• Equipment / Process Health checks.
• Complete Process Review for Compliance, Operations, Maintenance and Validation.
• Needs Assessment Audits: Perhaps as a precursor to a project to help define requirements.
• Pre-inspection Audits. These can be targeted at particular regulatory bodies? requirements.

Interim Management

In addition to managing the projects and work packages that we deliver, HPCS provides interim management resources to help you through particular periods of high workloads and technical skill shortages. This can sometimes be incorporated as part of a major project that we are delivering for you, or as a single resource to fit into your management structure for a period of time.