Solutions for the Pharmaceutical Industry

Along with the Food sector the Pharmaceutical faces among the highest levels of regulation of any industry. Once again we see the emphasis on the need to provide simple and intuitive manufacturing instructions to end users and their supervisors. Outdated or incorrect information circulating around the company is an ever present danger. Key quality processes, although fully documented, are often manual in nature and lacking in value.

These same processes in Singlepoint become dynamic, efficient and rich in data to help your company get progressively better at what it does. Some of the biggest names in the industry have assisted us directly in developing the specifications for Singlepoint.

SinglePoint brings process based solutions to virtually any activity.

• ISO9001 / ISO17025 / 21CFR Part 11 – Singlepoint’s many modules and process management capabilities give you the power to get on top of the task of managing your compliance to key industry standards such as ISO9001 and ISO17025. Virtually any process can be formalised within Singlepoint; stand alone spreadsheets and databases can be replaced with slick, highly visible workflows. Human error can be reduced or even eliminated; easy to use screens can replace lengthy input documents. On-demand, live data can replace business critical information buried in spreadsheets. Visibility and efficiency can replace countless hours lost to manually housekeeping the process. Applications include document control, complaints management, change management, product development, auditing, non-conformance management, LIMS and training records.

• Document Control – not only does Singlepoint DCS meet the compliance standards of 21CFR Part 11 it makes documents and other media available to end users within the context of the actual work they are doing. Easy and fast end user navigation is one of two key objectives. The second is tight, auditable control that ensures that your users can only ever be accessing the current revision of any given document.

• LIMS – Singlepoint is perfect for automating laboratory samples inspection processes. Because of its flexibility, you can configure your analytical parameters and formulas and combine these with powerful workflows to manage data entry, data validation, out-of-spec alerts, sign-offs and report generation. Individual records are archived to provide the all-important audit trail traceability and you can even configure companion modules to manage product specifications, lots, batches and product change management, non-conformances etc. All report formats are exportable into PDF, Excel and Word. An effective LIMS implementation will form the backbone of managing compliance to ISO17025.

• Program Management – some of our customers talk about Programs, others talk about Projects – some even talk about NPI (New Product Introduction). However, whatever they call it the problem seems to be the same and that is a lack of visibility between team members, between customers and suppliers and for management. Our flexible web based approach means that wherever you are you can see your project tasks, documents, reports, timelines and risk alerts. Built in to our Program Manager software is a fully integrated APQP authoring suite for FMEA's, Control Plans, Process Flow Diagrams etc.

• Reporting – top of the list of the “must have” features of Singlepoint is powerful and flexible management reporting. We have more than delivered on this requirement with Absolute Reporting. It matches the Singlepoint modules in terms of its ability to be configured to produce the exact reports you want and comes with superb features such as automatic run and delivery, compare and various export options such as PDF, XML and Microsoft Excel™.

• Application X – our commitment to flexibility is never better demonstrated than by the addition of this powerful custom module creation tool. Basically, there are more business processes out there than we can write separate modules for – so why even try? Instead, we give the ability to clone any of the existing modules and then re-name and customise the module to fit an entirely new application such as Supplier Quality, Auditing, Human Resource management – in fact virtually any business process can be captured and managed in this way.