RISE for chemicals and life sciences manufacturing.

RISE with SAP deployments inside chemicals manufacturers and life sciences manufacturers carry a regulated environment that combines the GxP framework administered by the United States Food and Drug Administration, the European Medicines Agency, and the equivalent national medicines authorities, with the process safety frameworks that apply to chemical manufacturing including the Seveso Directive in the European Union and the Process Safety Management standard in the United States. The deployment also carries the intellectual property dimension that protects the recipe data, the formulation data, the clinical data, and the operational data that the manufacturing site generates. The buyer team that approaches the RISE negotiation without these dimensions as structuring constraints will produce a contract that fails the inspection cycle, that creates exposure during a process safety event, or that compromises the protection of the intellectual property that the manufacturing operation depends on. This article walks through the regulatory landscape, the validation and qualification requirements, the process safety dimension, the intellectual property protection, and the negotiation of the validation schedule.

The regulatory landscape for chemicals and life sciences manufacturing

The regulatory landscape combines three frameworks that apply across the data, the operating environment, and the lifecycle of the regulated product. The GxP framework covers the good manufacturing practice, the good laboratory practice, the good clinical practice, and the good distribution practice that the regulated product must satisfy across the lifecycle. The framework applies to the SAP estate as the system of record for the manufacturing transactions, the batch records, the quality records, and the supply chain records that support the regulated product.

The process safety framework applies to the chemical manufacturing site and to any life sciences site that processes hazardous materials at scale. The framework establishes the documentation requirements for the process safety information, the process hazard analysis, the operating procedures, the training records, the management of change, and the incident investigation. The framework applies to the SAP estate as the system that captures many of the operating transactions that support the process safety documentation.

The data integrity framework applies across the regulated industries and combines the regulatory expectations of the inspecting authorities with the operating expectations of the buyer quality organisation. The framework establishes the controls on the data that the system processes, the audit trail that records any change to the data, the access controls that govern who can change the data, and the operational procedures that ensure the data is complete, consistent, accurate, attributable, legible, contemporaneous, original, and durable.

GxP, validation, and qualification requirements

The validation and qualification requirements establish the documented evidence that the SAP estate satisfies the regulatory expectations across the validated state of the system. The requirements apply to the initial implementation, to any change to the system across the operating period, and to any periodic review that the buyer quality organisation conducts against the system. The RISE contract introduces the additional dimension that the SAP delivery organisation operates many of the changes that would historically have been managed by the buyer IT organisation, and the validation framework needs to accommodate the SAP managed changes within the buyer validation lifecycle.

The initial validation covers the user requirements specification, the functional specification, the design specification, the installation qualification, the operational qualification, and the performance qualification that the regulatory framework expects. The validation is the buyer responsibility and the buyer quality organisation operates the validation through the standard validation lifecycle. The RISE contract should support the validation through the provision of the technical documentation that the validation requires and through the cooperation of the SAP delivery organisation with the validation activities that touch the operating environment.

The change validation covers the changes that occur across the operating period, including the changes that the SAP delivery organisation operates on the regulated estate. The contract should establish the change classification framework that defines the changes that the buyer can accept without revalidation, the changes that require a partial revalidation, and the changes that require a full revalidation. The framework should be supported by the obligation on SAP to provide advance notification of any change that crosses the defined thresholds, with the documented assessment of the change against the validation framework.

The periodic review covers the buyer review of the system at the defined frequency that the validation policy requires. The review confirms that the system remains in the validated state and that any change across the review period has been processed through the validation lifecycle. The review is the documentary basis that the buyer quality organisation will present to the inspecting authority at the next inspection cycle.

Process safety and operational continuity

The process safety provisions cover the data integrity and the operating continuity that the chemical manufacturing site requires. The provisions begin with the recovery time objectives and the recovery point objectives that the chemical manufacturing operation requires, which are typically more stringent than the recovery objectives that the SAP delivery organisation provides as standard. The buyer team should negotiate the recovery objectives against the operational continuity requirements of the manufacturing site, including the impact of any outage on the safety critical operations that the SAP estate supports.

The provisions should also cover the data integrity of the safety critical transactions, including the batch records, the calibration records, the maintenance records, the deviation records, and the operating procedures that the SAP estate captures. The data integrity should be supported by the technical controls that prevent any unauthorised modification of the records and by the audit trail that records any authorised modification with the full attribution that the regulatory framework requires.

The continuity provisions should include the documented arrangements for any extended outage that exceeds the operational tolerance of the manufacturing site, including the manual procedures that the operating team will follow during the outage, the documentation requirements that apply to the manual operation, and the reconciliation requirements that apply when the system is restored. The arrangements should be tested at the defined frequency that the buyer continuity policy requires.

Recipe and intellectual property protection

The recipe and intellectual property protection provisions cover the formulation data, the recipe data, the clinical data, the manufacturing process data, and the operational data that the SAP estate processes. The data is among the most sensitive that the buyer organisation holds, with the commercial value of the regulated product depending on the protection of the data against any unauthorised access or disclosure.

The protection should combine the contractual provisions on the confidentiality and the data handling with the technical controls on the encryption, the access management, and the audit trail. The contractual provisions should specify the sensitivity classification of the data, the controls that the SAP delivery organisation operates against the classification, and the obligations on the SAP organisation in the event of any access by an unauthorised party. The technical controls should include the customer managed key encryption, the logical isolation of the sensitive data from the wider deployment, and the audit trail that records any access to the data with the full attribution.

Negotiating the validation schedule

The validation schedule consolidates the GxP, the process safety, and the data integrity provisions into a single addendum to the RISE contract and provides the documentary basis that the buyer quality organisation will present to the inspecting authority. The schedule should be drafted in the language of the regulatory framework rather than in the language of the standard cloud contract, because the inspecting authority will read the schedule against the regulatory expectations rather than against the commercial expectations of the cloud arrangement. The schedule should cover the validation responsibilities, the change classification framework, the notification obligations on SAP, the cooperation obligations during the validation activities, the periodic review obligations, and the inspection support obligations that apply when the inspecting authority engages with the deployment. The schedule should be supported by the operating documentation that the SAP delivery organisation produces under the regulated cloud framework that SAP offers to regulated buyers.

Conclusion: the regulated environment shapes the contract

The RISE with SAP deployment for a chemicals or life sciences manufacturer is a regulated arrangement before it is a commercial arrangement. The regulated environment shapes the validation framework, the change management discipline, the process safety provisions, the data integrity controls, and the intellectual property protection that the deployment depends on. The buyer team that engages with the regulated environment as the structuring constraint produces a contract that supports the regulated operation across the contract term and that defends the deployment at every inspection cycle. The buyer team that treats the regulated environment as an addendum to a standard commercial negotiation produces a contract that fails the inspection, that creates exposure during a process safety event, or that compromises the protection of the intellectual property. The structuring approach is the difference between a sustainable regulated deployment and a deployment that creates regulatory and operational risk across the seven year contract term.